THE EFFECT OF MOBILE PHONE SHORT MESSAGE SERVICE (SMS…

1

THE EFFECT OF MOBILE PHONE SHORT

MESSAGE SERVICE (SMS) ON DRUG

ADHERENCE AMONG ADULT HYPERTENSIVE

PATIENTS ATTENDING THE GENERAL OUT-

PATIENT DEPARTMENT OF JOS UNIVERSITY

TEACHING, JOS

A DISSERTATION SUBMITTED TO THE NATIONAL

POSTGRADUATE MEDICAL COLLEGE OF NIGERIA IN PARTIAL

FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF

FELLOWSHIP OF THE COLLEGE IN FAMILY MEDICINE (FMCFM)

BY

DR WAKDOK, SABASTINE STEPHEN

M.B.B.S JOS (2006)

DEPARTMENT OF FAMILY MEDICINE,

JOS UNIVERSITY TEACHING HOSPITAL,

JOS, NIGERIA

MAY 2013

2

Declaration

It is hereby declared that this work is original. It has not been presented to any College for

award of fellowship or any University for award of degree. It has not been submitted elsewhere

for publication.

________________________________________

DR WAKDOK, SABASTINE STEPHEN

Date_______________

3

Certification

The study reported in this dissertation was carried out by Dr WAKDOK, SABASTINE

STEPHEN under our supervision. We have also supervised the writing of this dissertation.

SUPERVISORS:

1. SIGNATURE AND YEAR OF FELLOWSHIP_______________________________

DR NIMKONG LAR-NDAM (MBBS, FMCGP)

Consultant Family Physician

Jos University Teaching Hospital, Jos

DATE_______________________

2. SIGNATURE AND YEAR OF FELLOWSHIP__________________________________

DR SIMON L. PITMANG (B.M.B.Ch, FMCGP)



DATE_______________________

3. HEAD OF DEPARTMENT: SIGNATURE_______________________________

DR. J. K. A. MADAKI (MBBS, MA-HMPP, FWACP)


Head, Department of Family Medicine


DATE_______________________

4

DEDICATION

This work is dedicated to my wife, Olije. It was tough for both of us preparing

for the same examination in the same faculty at the same time. Thanks for your

support through this journey.

It is also dedicated to my elder brother Samuel, without whom I would not have

seen the four corners of a University.

To my dad and mum, Mr and Mrs Stephen Wakdok, thanks for giving me life and

to my sisters, Felicia and Priscilla you are the best.

5

Acknowledgement

My gratitude goes to God for the gift of life and his unrelenting faithfulness in my life.

This work would not have seen the light of the day if not for Dr Nimkong Lar-Ndam and Dr

Simon L. Pitmang, my supervisors who led me to the practice of holistic and psychosocial

medicine. Thank you for your sacrifice, dedication and support even when it was not

convenient for you. You donated your leisure time to me, I will never forget this!

I sincerely appreciate my teachers Dr Madaki, Dr Obadofin, Dr Longmut, Dr Dawam and Dr

Isandu for fine tuning my ideas and for their selfless efforts during the development of this

work.

I wish to express my gratitude to the consultants and residents of the Department of Family

Medicine of the Jos University Teaching Hospital for being there for me through my training

period. I appreciate your encouragement and support.

6

TABLE OF CONTENTS

Declaration...........................................................................................................................i

Certification.........................................................................................................................ii

Dedication…………...........................................................................................................iii

Acknowledgement...............................................................................................................iv

Table of Contents ................................................................................................................v

List of Tables ......................................................................................................................ix

List of Figures .....................................................................................................................x

List of Abbreviations ..........................................................................................................xi

Abstract ..............................................................................................................................xiv

Chapter One

1.0 Introduction………………………………………………………………………….....1

1.1 Background .....................................................................................................................1

1.2 Statement of the Problem……….. ..................................................................................5

1.3 Justification of the study…………………………………………………………..........9

1.4 Aim and Objectives………………………………………………………………........10

1.4.1 Aim…………………………………………………………………………………..10

1.4.2 Objectives…………………………………………………………………………....10

Chapter Two

2.0 Literature Review...........................................................................................................12

2.1 Hypertension ...................................................................................................................12

2.1.1 Brief History of Hypertension .....................................................................................12

2.1.2 Definition and classification of Hypertension…..……………………………………12

2.1.3 Epidemiology ...............................................................................................................19

2.1.4 Pathophysiology............................................................................................................26

7

2.1.6 Complications...............................................................................................................31

2.1.7 Management of Hypertension….. ...............................................................................34

2.2 Drug Adherence...............................................................................................................45

2.2.1 Overview.......................................................................................................................45

2.2.2 Definition of Adherence ..............................................................................................45

2.2.3 Measures of drug Adherence........................................................................................46

2.2.4 Drug Adherence in Management of Hypertension…...................................................50

2.2.4.1 Non-Adherence to HypertensionTreatment...............................................................50

2.2.5 Interventions to improve drug Adherence ....................................................................55

2.2.6 SMS and Drug Adherence ............................................................................................58

2.2.6.1 Definition of SMS ......................................................................................................58

2.2.6.2 Role of SMS in Drug Adherence................................................................................58

2.2.7 SMS and Hospital Missed Appointments......................................................................63

Chapter Three

3.0 Methodology ....................................................................................................................68

3.1 Study Design ....................................................................................................................68

3.2 Study Area.........................................................................................................................68

3.3 Study Population................................................................................................................69

3.4 Study Hypothesis ..............................................................................................................69

3.5 Sample size determination.................................................................................................69

3.6 Eligibility ..........................................................................................................................70

3.6.1 Inclusion Criteria...........................................................................................................70

3.6.2 Exclusion Criteria..........................................................................................................70

3.7 Recruitment, Allocation and Randomization...................................................................71

3.8 Instruments of data collection…………………………………………………………..72

8

3.9 Data collection..................................................................................................................72

3.10 Period and duration of Study…………………………………………………………..75

3.11 Data Analysis..................................................................................................................75

3.12 Ethical consideration……………………………………………………………….......76

Chapter Four

4.0 Results .............................................................................................................................77

4.1 Subjects flow through the study ......................................................................................77

4.2 Baseline characteristics of the study groups....................................................................79

4.3 Baseline medical history of the study groups...................................................................82

4.4. Baseline clinical characteristics of the study groups.......................................................86

4.5 Drug Adherence of the study groups………………………………………………........87

4.5.1 Pre-intervention drug Adherence of the study groups………………………………...87

4.5.2 Post-intervention drug Adherence of the study groups……………………………......88

4.6 Blood Pressure of the study groups………………………………………………………91

4.6.1 Baseline blood pressure of both groups……………………………………..................91

4.6.2 Post-intervention blood pressure of both groups………………………….....................93

4.7 Proportion of missed hospital appointments in the study groups…………………….......96

Chapter Five

5.0 Discussion........................................................................................................................99

5.1 Socio-demographic characteristics of the study groups……………………………….100

5.2 Medical history of the study participants………………………………………….......101

5.3 Drug Adherence of the study groups…………………..................................................102

5.4 Blood pressure of the study groups……………………………………………….........105

5.5 Proportion of missed hospital appointments in the study groups……………………...107

9

5.6 Strengths of the study …………………………………………………………………108

5.7 Limitations of the study……………………………………………………………….109

5.8 Conclusion…………………………………………………………………………......110

5.9 Recommendation………………………………………………………………………111

References……………………………………………………………………………….....113

Appendices…………………………………………………………………………….131-140

10

LIST OF TABLES

Table 2.1: JNC classification of blood pressure for Adults……..........................................17

Table 2.2: WHO/ISH classification of blood pressure..........................................................18

Table 2.3: Classes of antihypertensive drugs………………………………........................41

Table 4.1: Baseline socio-demographic characteristics of the study subjects………….......80

Table 4.2: Baseline medical history of the study groups…………………...........................83

Table 4.3: Pre-intervention clinical characteristics of the study groups…………………...86

Table 4.4: Baseline drug Adherence of the study groups………………………………….87

Table 4.5: Post-intervention drug Adherence of the study groups………………………...89

Table 4.6: Logistic regression of factors associated with improvement in Morisky score…90

Table 4.7: Baseline blood pressure of the study groups…………………………................92

Table 4.8: Post-intervention blood pressure of the study groups…………………………...94

Table 4.9: Proportion of missed hospital appointments at 12 weeks in both groups……......96

Table 4.10 Other post-intervention clinical characteristics of the study groups…………....98

11

LIST OF FIGURES

Figure 4.1: Study trial profile................................................................................................78

Figure 4.2: Showing reasons for missed medications in the study groups…………………85

Figure 4.3: Showing number of medications taken by study participants………………….85

Figure 4.4: Showing drug adherence of the study groups at baseline....................................88

Figure 4.5: Showing drug adherence of the study groups at 12 weeks.................................89

Figure 4.6: Showing SBP of the study groups at baseline…………….................................92

Figure 4.7: Showing DBP of the study groups at baseline….................................................93

Figure 4.8: Showing SBP of the study groups at 12 weeks………………………………...95

Figure 4.9: Showing DBP of the study groups at 12 weeks……………………………….95

Figure 4.10: Proportion of missed hospital appointments at 12 weeks……………….........97

Figure 4.11: Number of missed hospital appointments at 12 weeks……………………….97

12

LIST OF ABBREVIATIONS

% Percentage

< Less than

< More/greater than

± Plus or minus

≤ Less than or equals to

≥ More than or equals to

0C Degree(s) Celsius

ACE Angiotensin converting enzyme

ALLHAT Antihypertensive and lipid lowering treatment

to prevent heart attack trial

AIDS Acquired immune deficiency syndrome

BMI Body Mass Index

CVD Cardiovascular disease

Cm Centimetre

DALYS Disability adjusted life years

DASH Dietary Approaches to Stop Hypertension

DBP Diastolic blood pressure

ft feet/foot

g/dl gram(s) per decilitre

g/L gram(s) per litre

Hb Haemoglobin

HDL High density lipoprotein

HIV Human immunodeficiency virus

ISH International society of hypertension

13

JNC Joint National Committee on Prevention, Detection,

Evaluation and Treatment of High Blood Pressure

GOPD General Out-patient Department

JUTH Jos University Teaching Hospital

Kg Kilogram

LVH Left ventricular hypertrophy

M metre(s)

Mm Millimetre(s)

mEq Miliequivalent

NHANES National health and nutrition examination survey

MMAS Modified Morisky Adherence scale

PCV Packed Cell Volume

PHC Primary health care

SMS Short Message Service

SSA Sub-Saharan Africa

SBP Systolic blood pressure

UK United Kingdom

UK NHS United Kingdom National Health Service

USA United States of America

W.H.O World Health Organisation

χ2 Chi- square

14

APPENDICES

Appendix 1: Consent Form ..........................................................................................140

Appendix 2: The Study Questionnaire .........................................................................141

Appendix 3: Drug Adherence instruction sheet ...........................................................145

Appendix 4: Short Message Service (text reminder) ...................................................146

Appendix 5: Modified Morisky scale............................................................................147

Appendix 6: Ethical Clearance......................................................................................149

15

ABSTRACT

Introduction: Non-adherence to medication in hypertension is a major problem worldwide.

Adherence to medications among adult hypertensive patients ranges between 50% to 72% in

the developed countries and 23% to 65% in most African countries including Nigeria. At the

beginning of this study the drug adherence rate in both study groups was only 27%. This is

below the World Health’s organisation recommended drug adherence rate of 80-85% for

chronic diseases like hypertension and this has led to poor blood pressure control and

complications of hypertension.

Objectives: To determine the effect of mobile phone short message service (SMS) on drug

adherence among adult hypertensive patients with a view to recommending such intervention

to achieve optimum blood pressure control.

Study Design/Setting: A randomized controlled trial involving 78 adult hypertensive patients

aged 18 years and above on antihypertensive drugs attending the General Out-patient

Department of Jos University Teaching Hospital, Jos.

Methods: Subjects were randomly allocated to the control and the intervention groups. The

intervention offered was weekly SMS reminders over a 12 weeks period. Data collected from

the subjects include socio-demographic data, medical and drug history. Drug adherence rate

was measured using the modified Morisky adherence scale (MMAS) questionnaire that was

self-administered. Focused physical examination was done including blood pressure. Subjects

were followed up monthly over 12 weeks during which measurements were repeated.

Results: There was a higher mean change in Morisky score at the end of 12 weeks in the

intervention group of -3.31 versus -0.98 in the control group. This was statistically significant

(t-test=12.67, p<0.001). At the end of 12 weeks, there was a higher drug adherence rate in the

16

intervention group of 88.9% following weekly SMS reminders and drug adherence counselling

compared to 54.1% in the control group that had only drug adherence counselling. This

difference in drug adherence rate between the two groups was statistically significant

(χ2=5.9932, p=0.015).

There was also a higher mean reduction in systolic blood pressure of -22.99mmHg and diastolic

blood pressure of -19.09mmHg in the intervention group compared to -7.26mmHg systolic

blood pressure and -5.29mmHg diastolic blood pressure in the control group. The mean SBP

reduction between the two groups was statistically significant (t-test=8.85, p=<0.001) and the

mean DBP reduction between the two groups was also statistically significant (t=9.17,

p=<0.001).

There was no statistical significant difference in the proportion of missed hospital appointments

between the intervention and control group at the end of 12 weeks; 7.7% versus 17.9%

respectively (χ2=1.84, p=0.18). However, the intervention group had less proportion of study

participants with missed hospital appointments at the end 12 weeks following weekly SMS

reminders.

All data was analysed by Epi info version 3.5.1 2011 (Centre for Disease control and

Prevention, Atlanta Georgia, USA).

Conclusion: Weekly SMS reminders along with drug adherence counselling led to significant

improved drug adherence rate and mean reduction in blood pressure among adult hypertensive

patients attending General Out-patient Department of Jos University Teaching Hospital. There

were also a less proportion of subjects with missed hospital appointments following the

intervention at the end of 12 weeks.

SMS technology proved to be an important tool in improving the clinical outcome of

hypertensive patients in this study.

17

CHAPTER ONE

1.0 INTRODUCTION

1.1 BACKGROUND OF THE STUDY

Chronic diseases are now the major cause of death and disability worldwide, responsible for

59% of deaths and 46% of the global burden of disease.1 The number of persons with chronic

illness is growing at an astonishing rate because of the rapid aging of the population and the

greater longevity of persons with many chronic conditions.2 Diabetes, an important component

of the non-communicable diseases, is undoubtedly a rising problem globally.2

Diabetes mellitus is a metabolic disorder characterized by chronic hyperglycaemia due to

disturbances of carbohydrate, fat, and protein metabolism that are associated with absolute or

relative deficiencies in insulin secretion.3 The number of people with diabetes is increasing due

to population growth, aging, urbanization, and increasing prevalence of obesity and physical

inactivity.4 The dramatic worldwide increase in the prevalence of type 2 diabetes is posing a

massive health problem in both developed and developing countries.5 Interestingly, in

developed countries, lower socioeconomic groups are most affected, while, in developing

countries, the reverse applies.6 The magnitude of the healthcare problem of type 2 diabetes

results not just from the disease itself but also from its association with obesity and

cardiovascular risk factors, particularly dyslipidaemia and hypertension.7

Type 2 diabetes is the predominant form of diabetes in sub-Saharan Africa, accounting for over

90% of cases. As 50% of cases of type 2 diabetes are currently undiagnosed, enhanced

detection and diagnosis are critical.7

Diabetes presents a major challenge to the health care industry now and in the foreseeable

future. However, strategies for the improved management of diabetes and its associated

18

conditions are available. Compelling evidence indicates that controlling glycaemic levels as

well as hypertension and dyslipidaemia in diabetes patients cost-effectively reduces the risk of

related morbidity and mortality and improves their quality of life.8

The epidemic of type 2 diabetes and the recognition that achieving specific glycaemic goals

can substantially reduce morbidity have made the effective treatment of hyperglycaemia a top

priority.9

Diabetes is a complex chronic disorder with major short- and long-term health implications.

Diabetes care hinges on the daily commitment of the person with diabetes to self-management,

balancing appropriate lifestyle choices and pharmacologic therapy. Improving clinical

outcomes in diabetes requires patients to undertake and sustain a complex array of self-care

behaviours, including taking medications, monitoring blood glucose levels, following a diet,

engaging in regular exercise, and caring for their feet. These and other skilled behaviours to

promote health and prevent complications are often called “self-management.” How best to

evaluate and support patients’ diabetes self-management is a critically important question.10

Improving diabetic self-management is critical in improving glycaemic control. Multiple

studies have found that diabetes self-management education (DSME) is associated with

improved diabetes knowledge, improved self-care behaviour and improved clinical outcomes

such as lower HbA1c, improved quality of life, healthy coping, and lower costs. Patients’

behaviour alone does not determine glycaemic control but these studies have shown significant

association between self-management and glycaemic control. However; the studies are cross-

sectional and so it might be that patients with better glycaemic control assess their self-

management as better.

Medical care then must assure that persons with chronic illness have the confidence and skills

to manage their condition; the most appropriate treatments to assure optimal disease control

19

and prevention of complications; a mutually understood care plan; and careful, continuous

follow-up.1

Decades ago, pioneers such as John Runyon recognized that the effective management of

chronic illness requires a new kind of practice designed expressly to help patients meet the

challenges of chronic disease.2 More recently, stronger evidence suggests that busy practices

can redesign their care and do much better than “care as usual.” For example, a Cochrane

Collaboration review carefully examined the more rigorously tested interventions to improve

primary care for diabetes. Among the forty-one studies examined, many showed increases in

recommended care processes such as the prevalence of eye or foot examinations and a few

improved health and disease-control outcomes. Also a few randomized controlled trials

revealed that the group receiving the experimental program achieved average improvements in

blood glucose control (reduction in HbA1c of 1 percent or more) that, if sustained over time,

would result in a 21 percent reduction in mortality, a 14 percent reduction in myocardial

infarction, and a 37 percent reduction in microvascular complications.2

Today’s medical system is optimized for the delivery of acute, episodic care by individual

physicians, yet the primary burden on the system is from chronic illnesses that are not

effectively managed under the current healthcare system.12 Evidence-based guidelines from the

American Diabetes Association (ADA) describe a care pattern that, if followed, would greatly

reduce the impact of diabetes and its complications, yet repeated studies in a variety of settings

continue to show suboptimal processes or outcomes of care.13 The Chronic Care Model (CCM)

was designed by Wagner and colleagues to build on the interrelationships between six

evidence- based elements that lead to improved clinical quality. It aims to facilitate productive

interactions between “informed and activated patients” and “prepared, proactive practice

teams” For example, for patients to engage in proactive care (delivery system design), practices

need to be able to view all of the patients in their panels (clinical information systems) who

20

need certain guideline-based treatments (decision support), and patients must agree to any

changes in their care and integrate them into their lives (self-management support). Increasing

access to effective programming in the community through linkages with the relevant agencies

is a cost-effective way to obtain important services such as nutrition counseling or peer-support

groups (integration of community resources). For all these to occur chronic illness

improvement should be represented in the organization’s goals (healthcare organization

redesign).2,14

Implementation of the CCM from the patient perspective can be assessed using the Patient

Assessment of Chronic Illness Care (PACIC) survey. It focuses on the receipt of patient-

centred care and self-management behaviours. It is a 20-item patient report instrument that

assesses patient’s receipt of clinical services and actions consistent with the CCM.15

Studies done in Nigeria have shown that the morbidity and mortality associated with diabetes

is high due to suboptimal management and noncompliance with global standards.16 Though

these studies were cross-sectional and might not reflect the actual magnitude of the disease.

Studies have also shown the need for restructuring of the healthcare delivery systems in Nigeria

in order to adopt more appropriate and effective preventive treatment strategies in the

management of diabetes in Nigeria.

Interventions based on the CCM have not been widely or systematically adopted in primary

care practices, however, and few data exist to demonstrate that the incremental incorporation

of CCM elements in small, independent primary care practices is associated with better clinical

outcomes.12 These studies are limited by the self- reported nature of both clinician use of CCM

elements and processes of care measures. But the patient report of services and laboratory

ascertainment of physiologic data lends some strength to the associations.

21

Although quality diabetes care is essential to prevent long-term complications, care often falls

below recommended standards regardless of healthcare setting or patient population,

emphasizing the necessity for system change.16

1.2 STATEMENT OF THE PROBLEM

Diabetes is a common chronic disease. It also meets all 3 criteria for a public health disorder

“a high disease burden, changing burden suggesting preventability, and fear that things are

unknown and out of control.”17

The United States and the rest of the world are in the midst of a diabetes epidemic.18 The global

prevalence of diabetes was 8.3% in 2011 and is still on the increase, particularly in developing

countries, where provision and delivery of care is most difficult.4 In Africa, the prevalence is

3.8% and is rapidly on the increase, especially among urban communities. The reason can be

attributed principally to the nature of food consumed and lifestyles adopted. According to

Sobnigwe and colleagues, ‘the prevalence of diabetes mellitus and other non-communicable

diseases is on the rise in African communities due to the ageing of the population and drastic

lifestyle changes and accompanying urbanization and westernization.19

Sub-Saharan Africa is not immune to the process, and is experiencing a triple and in many

instances, a quadruple burden of disease, as the traditional infectious diseases such as malaria

and tuberculosis have been joined by non-communicable diseases in addition to HIV.6 All this

occurs in a region in which over 40% of the population live on less than US$1/day.20

It threatens to overwhelm the healthcare system in the near future. Sadly, the majority of the

people with diabetes in developing countries are within the productive age range of 45–64 years

(179 million). These are the same individuals who are expected to drive the economic engines

of their countries in order to achieve the agreed international development goals. Besides their

22

reduced productivity, diabetes further imposes a high economic burden in terms of healthcare

expenditure, lost productivity, and foregone economic growth.21

Diabetes and its complications impose significant economic consequences on individuals,

families, health systems and countries.21 The threat is growing, the number of people, families

and communities afflicted is increasing. This growing threat is an under-appreciated cause of

poverty and hinders the economic development of many countries.21 Diabetes takes a

staggering toll on the people in Nigeria and the economic burden is heavy.22

In resource-poor countries, shortage of insulin, other drugs, monitoring and laboratory

facilities and trained staff all lead to serious shortfalls in diabetes care.23 The rural areas of

Africa present particular problems, due to scattered populations, difficulties in access to clinic

facilities, poor provision of health care personnel, and shortage of drugs and equipment.24

These factors potentially lead to poor glycaemic control and a high burden of complications.25

Very little research has been carried out concerning care delivery and its problems in such

areas. 24

The growing number of persons suffering from major chronic illnesses face many obstacles in

coping with their condition, not least of which is medical care that often does not meet their

needs for effective clinical management, psychological support, and information.2 The

physical, social, and economic burden of diabetes mellitus result mostly from the complications

of the disease, which occur because of poor compliance to treatment. Studies done in Kano by

Lawan and colleagues showed that diabetic patients are being selective on the use of the disease

control measures prescribed to them by their physicians.26 However, Physicians commonly

ignore this important aspect of diabetic management.

Well-designed interactions between practice team and patient will be needed to complete the

important clinical and behavioral work of modern chronic illness care. Evidence suggests that

23

the typical acute problem–oriented visit practiced in the primary care settings, which is similar

to that practised in Nigeria is a barrier to such care.4

Type 2 diabetes accounts for 90% of diabetes and people living with type 2 diabetes are more

vulnerable to varied forms of both short- and long term complications, which often lead to their

premature death. This vulnerability to increased morbidity and mortality is as a result of the

commonness of this type of diabetes, its insidious onset, and late recognition, especially in

resource-poor developing countries like Nigeria.27 Studies have shown that in Nigeria and

many sub Saharan countries, professional adherence to approved guidelines for diabetes care

is poor. It also showed that Nigerians are at substantial risk of premature death and

complications related to diabetes even while in care.28 A study by Chijioke and collegues in

Ilorin showed that contributory factors to the high mortality were ignorance, poor hygiene,

infections, lack of foot care and inadequate glycaemic/blood pressure control. This emphasises

the importance of early diagnosis of diabetes and proper management.29

To curb this scourge of diabetes, public health interventions are required to prevent diabetes or

delay the onset of its complications.30 This will entail redesigning of the health care structure

with emphasis on self- management education. CCM emphasizes self-management training

and counselling and patient participation as essential in improving outcome in the management

of diabetes.

Diabetes is a major challenge for the health care system and especially for the primary care

provider. There is a dearth of information on the extent to which diabetic patients receive care

congruent with the chronic care model (CCM) and evidence-based behavioural counseling.31

While CCM has been shown to improve the care of patients with chronic illnesses, primary

care physicians have been unprepared in its use, and residencies have encountered challenges

in introducing it into the academic environment.14 The lack of physician training in chronic

illness management is an obstacle.14 This might be due to the fact that there is no laid down

24

CCM protocol in most health care settings, though the fact that aspects of CCM are difficult to

implement due to the low economic status of most patients and lack of electronic medical

records in most primary care settings might be a contributing factor. The public health care

system is overburdened and under-resourced, often leading to overcrowded clinics, inadequate

number of staff, high patient load, short consultation time and poor record keeping. A huge

burden is placed on these public health facilities and may contribute to the quality of care

delivered to chronic disease patients.32

1.3 JUSTIFICATION OF STUDY

The main justification for this study is that the findings may lead to recommendations that

would improve the management of diabetes and outcome of care. Although diabetes, especially

type 2 DM, is a major cause of morbidity and mortality world-wide, the associated burden is

felt more in developing countries like Nigeria because of delays in diagnosis, and late

presentation and poor compliance with recommended management guidelines. Interventions

based on the CCM have not been widely or systematically adopted in primary care practices in

Nigeria. Studies have shown that small primary care practices have been able to incorporate

elements of the CCM into their practice style, often without major structural change in the

practice. Despite advances in the effectiveness of treatment, research shows that patients

frequently do not get the care they want or need.1

Restructuring of the health system is important in order to improve the outcome of care of

chronic illnesses like diabetes in Nigeria. A Cochrane review showed that complex

interventions that only target providers’ behavior did not change patient outcomes unless

accompanied by interventions directed at patients.2 Hence implementation of elements of the

CCM involving patient self- management support is a step in redesigning chronic care in

resource poor countries Nigeria. Because implementing and maintaining CCM requires on-

25

going advocacy as it requires educational and financial support, and a leadership committed to

change.

Family physicians play a key role in chronic disease prevention, identification and management

since they are the frontlines and gateway to the healthcare system.33 A survey done by Madaki

and collegues in Jos University Teaching Hospital General Out-Patient Department in 2007

showed that 3% of the total number of patients seen are diabetic.34 Hence it is one of the

common diseases managed by the family Physician. They are in the best position to deal with

chronic disease. Their unique training, based on the principles of Family Medicine, is well

suited to this challenge. They are skilled clinicians who remain up to date and capable of

incorporating best evidence into clinical regimens as new information emerges.

The doctor-patient relationship is the hallmark of family medicine. As family doctors follow

their patients over time, a trusting relationship develops. This relationship is key to engaging

the patient in the management of own their disease(s) by incorporating self management plans

into their daily lives, an essential element of the Chronic Care Model that encourages high

quality chronic disease care.35 Furthermore, family physicians come to understand the illness

experience of their patient with chronic disease. Patient engagement in the disease process and

management is enhanced when care is provided within the context of the illness experience for

any individual patient.

Family physicians focus on prevention, which is the key to preventing diabetes and further

complications when already established. They coordinate the team based care which is essential

in the management of diabetes. Only family doctors have the dedication to continuity of care

that enhances chronic disease management. They see their patients in the office / clinic, at

home, hospital, and in long term/chronic care settings.

http://theconference.ca/index.php?option=com_content&view=article&id=330:the-chronic-care-model&catid=72:april&Itemid=194

26

Elements of the CCM to be implemented in this study will involve patient self- management

support, aspects of delivery system design through appropriate referral, and integration of

community resources by advocacy to join the local Diabetic association. These are aspects of

the CCM that can be incorporated into the health care delivery in resource poor settings like

Nigeria. Also, counselling on self-management behaviour modification can be effected in

patients irrespective of gender, literacy or financial status. The effect of these interventions on

self- management behaviour and glycaemic control of patients in our setting will be evaluated

and thus identify areas where changes can be made to improve diabetic care. The outcome of

the study could lead to recommendations aimed at improving the outcome of diabetes

management in a cost effective manner.

27

1.4 AIMS AND OBJECTIVES

AIM OF THE STUDY

To determine the effect of the chronic care model on self-management behaviour and

glycaemic control among adults 18 years and above with Type 2 Diabetes attending the

General out-patient department, Jos university teaching hospital (GOPD), JUTH, Jos , Plateau

State with a view to recommending its use in routine care so as to ensure improved diabetes

care in patients.

SPECIFIC OBJECTIVES

1. To determine the mean change in glycated haemoglobin in subjects allocated to the

chronic care model versus usual care.

2. To determine the mean change in self-management behaviour in subjects allocated to

the chronic care model versus usual care.

3. To determine the mean change in Patient Assessment of Chronic Illness Care (PACIC)

scores in subjects allocated to the chronic care model versus usual care using the PACIC

scale.

28

CHAPTER TWO

2.0 LITERATURE REVIEW

2.1 DIABETES MELLITUS

2.1.1 DEFINITION

Diabetes is a group of metabolic diseases of multiple aetiologies characterized by

hyperglycemia due to disturbance of carbohydrate, fats and protein metabolism resulting from

defects in insulin secretion, insulin action, or both.11

2.1.2 EPIDEMIOLOGY

Chronic diseases, such as heart disease, stroke, cancer, chronic respiratory diseases and

diabetes, are by far the leading causes of mortality in the world, representing 63% of all deaths.

Out of the 36 million people who died from chronic disease in 2008, nine million were under

60 and ninety per cent of these premature deaths occurred in low- and middle-income

countries.36

World Health Organization (WHO) projections show that non- communicable diseases (NCDs)

will be responsible for a significantly increased total number of deaths in the next decade. NCD

deaths are projected to increase by 15% globally between 2010 and 2020 (to 44 million

deaths).37 The greatest increases will be in the WHO regions of Africa, South-East Asia and

the Eastern Mediterranean, where they will increase by over 20%. In the African Region, there

are still more deaths from infectious diseases than NCDs.37 Even here, however, the prevalence

of NCDs is rising rapidly and is projected to cause almost three-quarters as many deaths as

communicable, maternal, perinatal, and nutritional diseases by 2020, and to exceed them as the

most common causes of death by 2030.37

In contrast, in the European Region, WHO estimates there will be no increase. In the African

Region, NCDs will cause around 3.9 million deaths by 2020. The regions that are projected to

29

have the greatest total number of NCD deaths in 2020 are South-East Asia (10.4 million deaths)

and the Western Pacific (12.3 million deaths).37

Figure 2.1: from International Diabetes Federation. The Diabetes Atlas. Fifth Edition.39

Diabetes is certain to be one of the most challenging health problems in the 21st century.38 The

prevalence of diabetes mellitus has reached epidemic levels globally.38 It is now recognized

that developing countries presently face the greatest burden of diabetes.38 The WHO estimated

that there were 135 million people in the world with diabetes in 1995 and 154 million in 2000.37

The most recent IDF Atlas (2011) pointed to an even greater current and future problem by

http://www.idf.org/sites/default/files/da5/Fig 2.1 Prevalence of diabetes by region.jpg

30

calculating that, at present, diabetes affects 366 million people worldwide, with a projected rise

to 552 million by 2030.39 Each report has highlighted the fact that low- and middle-income

countries will bear the brunt of the increase accounting for 80% and that Africa will contribute

significantly to this rise.39 The greatest increases in numbers of people with diabetes over the

next 20 years will occur in low- and middle-income countries.39 This is driven by an increase

in the adult population, people living longer, and through changes in behaviours associated

with rapidly increasing urbanization and development. Key changes in behaviour include

reduced physical activity, a shift to higher calorie diets, and the associated increases in

obesity.40

Type 2 diabetes is now a common and serious global health problem. Type 2 diabetes makes

up about 85 to 95% of all diabetes in high-income countries and may account for an even higher

percentage in low- and middle-income countries. 39 The greatest number of people with

diabetes is in the 40 to 59 age group (179 million).39 It is expected that this number will increase

to 250 million by 2030.39 The majority of people with diabetes in low- and middle-income

countries are under 60 years of age and in the peak of their productive years. This is different

from the age distribution found in high-income countries which has many more people with

diabetes in older age groups. People with poorly managed diabetes or people who do not have

access to proper care and treatment are more likely to miss work due to the consequences of

the disease, which can lead to loss of productivity. This in turn has a negative effect on the

economy in those countries.40

There are about four million more men than women with diabetes (185 million men versus 181

million women) in 2011. However, this difference is expected to decrease to two million (277

million men versus 275 million women) by 2030.39

31

Figure 2.2: From International Diabetes Federation. The Diabetes Atlas. Fifth Edition.39

The lowest rates of type 2 diabetes are found in rural communities where people retain

traditional lifestyles. In low- and middle-income countries, the number of people with diabetes

in urban areas is 172 million while 119 million live in rural areas.39

Currently in the United States, approximately 17 million people or 8.6% of the adult population

aged 20 and older have diabetes. Each year 1 million new cases are diagnosed, yet almost 6

million people, or around one-third of those with diabetes, remain undiagnosed. Another 16 to

26 million people have “pre-diabetes.18

Although the prevalence of diabetes is lower in developing countries; these countries have

experienced the greatest increase in diabetes. In sub-Saharan Africa, the rising prevalence

presents a substantial public health and socioeconomic burden in the face of scarce resources.41

32

The African continent accounted for approximately 14.7million people with diabetes in 2011

with a regional prevalence of 3.8%.42 The Africa Region of IDF, which mainly includes sub-

Saharan Africa, accounted for approximately 7.1 million people with diabetes in 2011.43

Estimates for the region for 2030 are likely to double and reach 28 million.42,43 Nigeria has the

highest number of people with diabetes (3.0 million), followed by South Africa (1.9 million),

Ethiopia (1.4 million), and Kenya (769,000). The top six countries with the highest number of

people with diabetes make up just over half of the total number in the region.42, Reunion has

the highest diabetes prevalence in the African Region (16.3%). followed by Seychelles

(12.4%), Botswana (11.1%) and Gabon (10.6%). Consistent rural-urban disparities in the

prevalence of type 2 diabetes have been noted in SSA with urban areas recording higher rates.

The studies from Tanzania (urban/rural ratio of 5:1) and Cameroon (ratio of 2:1) both confirm

the marked urban/rural discrepancy in diabetes prevalence. It is estimated that undiagnosed

diabetes accounts for 60% of those with the disease in Cameroon, 70% in Ghana and over 80%

in Tanzania.42

More than 90% of cases in Nigeria are type 2 and this is the predominant diabetes all over the

world.44 Diabetes has an age-adjusted prevalence rate of between 1–10% in rural and urban

areas. In Nigeria, with over 250 tribes and different cultures and food values, the prevalence

values has not been uniform.45 Over the past 30 years the prevalence of diabetes has been

increasing steadily. In 1971, a hospital survey by Osuntokun et al46 in Ibadan estimated a

prevalence of 0.4%; In 1989, while screening for Diabetes during a World Diabetes Day in

Lagos metropolis, Ohwovoriole et al47 found a prevalence of undiscovered Diabetes of 1.6%;

A national survey in 1992 by the Non-communicable Disease Expert Committee of the Federal

Ministry of Health recorded a prevalence of 2.2% (National) - lowest 0.5% in Mangu, Plateau

State and highest 7% in Lagos Island,44,45 A survey done in rural South-western Nigeria places

the prevalence at 2.5%, while in another study done in urban Port Harcourt, the crude and

33

standardized prevalence rates of type 2 diabetes was 6.8 and 7.9% respectively.44,45 In a survey

by Puepet among urban adults in Jos metropolis the prevalence of Diabetes was found to be

3.1%.48 More recent studies in Port-Harcourt and Zaria showed a prevalence of 7.9% and 5%

respectively.44,49 A second survey in Jos in 2004 recorded a prevalence of 10.3%.50 The

International Diabetes Federation 2010 country rankings of Diabetes place the prevalence in

Nigeria at 3.9%.52 The difference in prevalence may be due to the fact that Puepet and

colleagues carried out their survey in an urban settlement which usually has a higher prevalence

due to urbanization and western influence, compared to the IDF country rankings which factors

both rural and urban settlements. However the country ranking might also have been under-

reported since they are hospital based reports compared to the community based studies done

by Puepet and colleagues.

2.1.3 DIAGNOSIS

The occurrence of diabetes-specific complications has been used to derive diagnostic cut-points

for diabetes. The diagnosis of diabetes is based on the following criteria:53

1. The spectrum of fasting plasma glucose (FPG) and the response to an oral glucose load

varies among normal individuals.

2. Diabetes is defined as the level of glycaemia at which diabetes-specific complications

occur rather than as deviations from a population-based mean.

Fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL) or

Symptoms of diabetes plus random blood glucose concentration ≥ 11.1mmol/L (200

mg/dL) or

Two-hour plasma glucose ≥ 11.1 mmol/L (200 mg/dL) during an oral glucose tolerance

test or

34

Glycated haemoglobin HbA1c of ≥ 6.5%.

Random is defined as without regard to time since the last meal. Fasting is defined as no caloric

intake for 8 – 12 hours. The oral glucose tolerance test should be performed as recommended

by the World Health Organisation (WHO); using a glucose load containing the equivalent of

75g anhydrous glucose dissolved in water.53 The diagnostic test should be performed using a

method that is certified by the National Glycohemoglobin Standardization Program (NGSP)

and standardized or traceable to the Diabetes Control and Complications Trial (DCCT)

reference assay.11

CLASSIFICATION

WHO (1999) classify diabetes into four clinical groups:11

I. Type 1 diabetes (β-cell destruction, usually leading to absolute insulin deficiency)

A. Immune-mediated

B. Idiopathic

II. Type 2 diabetes (may range from predominantly insulin resistance with relative insulin

deficiency to a predominantly insulin secretory defect with insulin resistance)

III. Other specific types of diabetes

A. Genetic defects of β -cell function

B. Genetic defects in insulin action

C. Diseases of the exocrine pancreas

D. Endocrinopathies

E. Drug- or chemical-induced

F. Infections

35

G. Uncommon forms of immune-mediated diabetes

H. Other genetic syndromes sometimes associated with diabetes

IV. Gestational diabetes mellitus (GDM)

2.1.5 PATHOPHYSIOLOGY

Plasma glucose concentration is a function of the rate of glucose entering the circulation

(glucose appearance) balanced by the rate of glucose removal from the circulation (glucose

disappearance).54 The maintenance of normal glucose homeostasis is largely dependent on

three factors: normal insulin secretion by pancreatic beta-cells in response to glycaemic

stimulus, ability of insulin to inhibit endogenous hepatic glucose production (insulin

sensitivity), and to some extent, the ability of the glucose to independently suppress hepatic

output (glucose selective).54

In the post absorptive state the majority of total body glucose disposal takes place in insulin-

independent tissues. Thus, approximately 50% of all glucose use occurs in the brain, which is

insulin-independent and becomes saturated at a plasma glucose concentration of approximately

40 mg/dL.55 Another 25% of glucose disposal occurs in the splanchnic area (liver plus gastro

intestinal tissues), which is also insulin-independent. The remaining 25% of glucose use in the

post absorptive state takes place in insulin-dependent tissues, primarily muscle, and to a lesser

extent adipose tissue. Basal glucose use, approximately 2.0 mg/kg/min, is precisely matched

by the rate of endogenous glucose production. Approximately 85% of endogenous glucose

production is derived from the liver, and the remaining 15% is produced by the kidney.56

Glycogenolysis and gluconeogenesis contribute equally to the basal rate of hepatic glucose

production. Following glucose ingestion, the increase in plasma glucose concentration

stimulates insulin release, and the combination of hyperinsulinemia and hyperglycemia

stimulates glucose uptake by splanchnic (liver and gut)and peripheral (primarily muscle)

36

tissues and suppresses endogenous(primarily hepatic) glucose production.57 The majority

(80%–85%) of glucose uptake by peripheral tissues occur in muscle, with a small amount (4%–

5%) metabolized by adipocytes.56 Although fat tissue is responsible for only a small amount of

total body glucose disposal, it plays a very important role in the maintenance of total body

glucose homeostasis by regulating the release of free fatty acids (FFA)from stored triglycerides

and through the production of adipocytokines that influence insulin sensitivity in muscle and

liver. Impaired insulin secretion is found uniformly in type 2 diabetic patients in all ethnic

population.57 Early in the natural history of type 2diabetes, insulin resistance is well established

but glucose tolerance remains normal because of a compensatory increase in insulin secretion.

In type 2 diabetics, the fasting plasma insulin concentration is normal or increased and basal

insulin secretion is elevated. As the fasting glucose rises from 80 to 140 mg/dL, the fasting

plasma insulin concentration increases progressively, reaching a peak value 2.0–2.5-fold

greater than in normal weight, non-diabetic, age-matched controls. The progressive rise in

fasting plasma insulin level can be viewed as an adaptive response of the pancreas to offset

the progressive deterioration in glucose homeostasis. When the FPG exceeds 140 mg/dL, the

beta cell is unable to maintain its elevated rate of insulin

secretion, and the fasting insulin concentration declines precipitously. This decrease in fasting

insulin level has important physiologic implications, because it is at this point that hepatic

glucose production (the primary determinant of the FPG concentration) increases.56 A number

of pathogenic genetic and acquired factors have been implicated in the progressive

impairment in insulin secretion. Pancreatic beta cells are in a constant state of dynamic change,

with continued regeneration of islets from ductal endothelial

cells of the exocrine pancreas and simultaneous apoptosis.58

The pathophysiology of type 2 diabetes is multi-faceted and includes insulin secretion from

pancreatic islet cells, insulin resistance in peripheral tissues, and inadequate suppression of

37

glucagon production. These processes result in inadequate uptake, storage, and disposal of

ingested glucose accompanied by elevated hepatic production of glucose and hyperglycemia.

Loss of β-cell mass in the pancreatic islets can progress to a clinically significant degree even

in patients with IGT, such that at the time of diagnosis of type 2 diabetes, a significant number

of cells may already be lost.59 Bakari and colleagues in Northern Nigeria, in their work found

significant (60%) pancreatic beta cell dysfunction among type 2 diabetic patients.60

Apart from genetic predisposition, acquired factors causing insulin resistance include central

obesity and physical inactivity. Excess production of free fatty acids and over expression of

tumour necrosis factor alpha (TNF) by adipocytes are proposed mechanisms for the

development of insulin resistance. Both hepatic and peripheral insulin resistance result in

abnormal glucose production by the liver i.e. increase hepatic glucose output. In addition, the

production of glucose by the liver is regulated by the relative actions of insulin and glucagon

to suppress or activate glucose production respectively.56

Multiple genes have been identified that are involved in the development of type 2 diabetes,

increasing our understanding of the pathophysiology of type 2 diabetes and offering potential

new treatment options. Newer therapies for the management of type 2 diabetes include incretin-

based agents, which act by targeting many of the key pathophysiologic processes in type 2

diabetes, including enhancing insulin secretion and inhibiting glucagon production.59

2.1.6 COMPLICATIONS

People living with type 2 DM are more vulnerable to varied forms of both acute and chronic

complications, which often lead to their premature death. This vulnerability to increased

morbidity and mortality is seen in patients with type 2 diabetes because of the commonness of

38

this type of diabetes, its insidious onset and late recognition, especially in resource-poor

developing countries like Nigeria.61

Acute complications

Acute symptoms of diabetes are due to severe hyperglycaemia and include polyuria,

polydipsia, polyphagia, weight loss and blurred vision. Patients may exhibit increased

susceptibility to infections. Acute complications occurring in diabetes can broadly be divided

into metabolic and non-metabolic. The non-metabolic complications include severe infections

such as sepsis, malignant externa otitis etc. The acute metabolic (hyperglycaemic)

complications which include: Diabetic Ketoacidosis (DKA), Hyperglycaemic Hyperosmolar

State (HHS) and lactic acidosis.61 The underlying pathophysiological problem is absolute

(DKA) or relative DKA by definition consists of the occurrence of a triad: hyperglycaemia,

ketonaemia and high anion gap metabolic acidosis.61 HHS similar but different from DKA in

that ketonaemia is minimal, hyperglycaemia and osmolality are much higher and consequently,

dehydration is more severe.61 The basic underlying mechanism for both disorders is a reduction

in the net effective action of circulating insulin coupled with a concomitant elevation of counter

regulatory hormones such as glucagon, catecholamines, cortisol, and growth hormone.61 In

patients with DKA, the deficiency of insulin can be absolute or it can be insufficient relative to

an excess of counterregulatory hormones which rise in response to stress like infection, trauma

etc.61 In HHS, there is a residual amount of insulin secretion that minimizes ketosis but does

not control hyperglycemia. This leads to severe dehydration and impaired renal function,

leading to decreased excretion of glucose. These factors coupled with stress result in a more

severe hyperglycaemia than that seen in DKA. In addition, inadequate fluid intake contributes

to the hyperosmolality without ketosis, the hallmark of HHS. The clinical presentation of DKA

and HHS are similar, though with few areas of major difference. The patient with DKA is

usually young and lean while HHS is usually elderly. Both present with prostration, polyuria,

39

polydipsia and often have alteration in level of consciousness.61 Major areas of differences are

that clinical evolutions of symptoms tend to be relatively more rapid in DKA than HHS, usually

over a period of 2-3 days. Patients with DKA may also present with nausea and vomiting, and

occasionally abdominal pain. Kussmaul (fast and deep) breathing may occur in both types, but

especially in DKA. Other physical findings include dehydration, tachycardia and

hypotension.61

In the United States of America (USA) DKA occurs at the rate of 5-8 episodes per 1000 patients

with DM. In recent studies in the USA, it was estimated that hospitalizations for DKA during

the past two decades are increasing. The mortality rate of DKA prior to insulin treatment was

100%.62 With insulin treatment it is now at about 2% in good Centres. The mortality of HHS

is higher at about 15%.62 Although the mortality rate of these complications is reducing in

Western developed countries,63 the situation has not changed in developing countries like

Nigeria.61

In the Lagos University Teaching Hospital (LUTH), Hyperglycemic complications accounted

for 2.4% of all admissions and 27.8% of DM related admissions.62 Okoro and colleagues64 in

Ilorin reported a crude mortality rate of 22% and 25% for DKA and HHS respectively. More

recently, Ogbera and colleagues65 reported a crude mortality rate of 20% among 111 diabetic

patients in Lagos. These studies are however hospital based, hence actual figures might be

higher. Ignorance about diabetes and its acute complications, financial constraints, and an

inefficient health care system may be some of the factors responsible for this high mortality.65

Chronic complications

Chronic complications occur as a result of long term effect of hyperglycaemia. The risk of

developing diabetic complications is proportional to both the magnitude and duration of

hyperglycemia. Persistent hyperglycaemia leads to vascular damage and eventually end-organ

40

damage.66 Well-conducted epidemiological data regarding chronic diabetic complications in

Africa are limited. Most reports have small samples derived from tertiary referral clinics,

underlining the need for larger scale community-based studies. However, there is little doubt

that the prevalence of complications has increased in keeping with the rising occurrence of

diabetes.67

Generally, the injurious effects of hyperglycaemia are separated into macrovascular

complications (coronary artery disease, peripheral arterial disease, and stroke) and

microvascular complications (diabetic nephropathy, neuropathy, and retinopathy).66

Hyperglycemia, as assessed by the hemoglobin A lc (HbA 1c) measurement, is the prime cause

of diabetic microvascular complications and plays a role in the premature and accelerated

development of diabetic macrovascular complications.68

Most Nigerian diabetics have suboptimal glycaemic control, are hypertensives, and have

chronic complications of DM. Improved quality of care and treatment to target is recommended

to reduce diabetes-related morbidity and mortality.69

Diabetes Retinopathy

Diabetic retinopathy (DR) is a complication of diabetes mellitus (DM) that affects the blood

vessels of the retina and leads to blindness. The progression of retinopathy is gradual,

advancing from mild abnormalities, characterized by increased vascular permeability, to

moderate and severe non-proliferative diabetic retinopathy, characterized by the growth of new

blood vessels on the retina and posterior surface of the vitreous. DR is one of the most serious

complications of diabetes.70 Diabetic retinopathy is the leading cause of blindness in adults

between the ages of 20 and 65 in industrialized countries.71 It is said to account for 12% of new

cases of blindness in the USA and 11.9% of all blind registration in those aged 16–64 years in

the United Kingdom.72 Diabetic retinopathy is also a leading cause of blindness in developing

41

countries.73 Mbanya and Sobngwi looked at data for the prevalence of diabetic complications

in Africa and reported that retinopathy was present in 16–55% of people with diabetes.74

Ashaye and colleagues reported a prevalence of 42.1%.72 while studies done in LUTH showed

that it was the commonest diabetic chronic complication and was seen in 65% of patients.73

Diabetes Nephropathy

Diabetic nephropathy is the leading cause of renal failure in the United States. It is defined by

proteinuria > 500 mg in 24 hours in the setting of diabetes, but this is preceded by lower degrees

of proteinuria, or “microalbuminuria.” Microalbuminuria is defined as albumin excretion of

30-299 mg/24 hours. Without intervention, diabetic patients with microalbuminuria typically

progress to proteinuria and overt diabetic nephropathy.66 It is the leading cause of kidney

disease in patients starting renal replacement therapy and affects approximately 40% of type 1

and type 2 diabetic patients.75 Screening for diabetic nephropathy must be initiated at the time

of diagnosis in patient with type 2 diabetes,76 since approximately 7% of them already have

microalbuminuria at that time (Adler et al., 2003).75 However, the prevalence of

microalbuminuria before 5 years in this group can reach 18% especially in patients with poor

glycaemic and lipid control and high normal blood pressure levels.77 It is a leading cause of

end stage renal disease in Nigeria. The prevalence rose from 7% in 1967 to 56.5% in 1999.78

A study done in 2009 in Southern Nigeria revealed a prevalence of 72.63%.79

Diabetic neuropathy

Diabetic neuropathy is recognized by the American Diabetes Association (ADA) as “the

presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes

after the exclusion of other causes.66 Diabetes can affect the somatic and autonomic nervous

system. Diabetes is the leading cause of neuropathy in the Western world, and neuropathy is

42

the most common complication and greatest source of morbidity and mortality in diabetes

patients.80 It is estimated from a comprehensive collection of epidemiologic studies that the

prevalence of neuropathy in diabetes patients is approximately 30% in hospital patients and

20% in community patients. The primary risk factor for diabetic neuropathy is

hyperglycemia.80 Neuropathy is associated with pain in about 4% to 5% of all patients with

diabetes.66 Peripheral neuropathy is the most common chronic complication of diabetes.81 It is

the main risk factor in the pathogenesis of foot ulceration in diabetic patients.82 The diabetic

foot, characterised by the triad of neuropathy, infection, and ischaemia is a common and serious

complication of diabetes with associated long periods of hospitalization of the affected patient

and the risk of limb amputation.83

Foot complications in Africa are mainly as a result of infection in the neuropathic foot rather

than due to PVD.82 Although with the rapid urbanisation of communities across Africa, the

prevalence is on the increase. Chijioke and colleagues observed that diabetic foot ulceration

and gangrene were responsible for 40% of limb amputations, with about 35% of these

complicated by severe infection which accounted for 25% mortality in diabetic ketoacidosis.

The majority of the patients were traders and civil servants who were ignorant about foot care.29

Comprehensive foot care programs can reduce amputation rates by 44% to 85%.84 Since

peripheral arterial disease (PAD) is a major risk factor for lower-extremity amputation84 and

many patients are asymptomatic, screening for PAD is another important way to prevent

amputations.85

Diabetic autonomic neuropathy

Autonomic neuropathy can cause postural hypotension, vomiting, diarrhoea, bladder paresis,

impotence,sweating abnormalities, impaired light reflex, impotence and retrograde ejaculation.

Abnormal heart rateresponses and prolonged QT intervals have been associated with increased

43

risk of sudden death. The symptoms and signs of autonomic dysfunction should be elicited

carefully during the history and physical examination.11,88

Erectile Dysfunction

Erectile dysfunction (ED) is one of the chronic complications seen in men with diabetes

mellitus. Autonomic neuropathy is a common cause of ED, although vascular, psychogenic,

and endocrine factors are also important in its aetiology.87 The prevalence of ED in persons

with diabetes is between 35 and 75%.87; Shaeer and colleagues 88 reported a prevalence of

63.3% in Nigeria, while Olarinoye and colleagues89 reported a prevalence rate of 74% thus

showing a high prevalence of ED in diabetes. Adding screening and treatment for

complications can have a large impact on the quality of life for patients with diabetes.

Cardiovascular Disease

The clinical spectrum of cardiovascular disease is coronary heart disease, cerebrovascular

disease and peripheral vascular disease. Coronary heart disease includes; Angina (which may

be silent), acute coronary artery syndrome, congestive cardiac failure and sudden death.

Cerebrovascular accident includes; Stroke, transient ischaemic attacks and dementia. And

peripheral vascular disease includes; intermittent claudication, foot ulcers and gangrene.90 The

pathophysiology of the link between diabetes and cardiovascular disease (CVD) is complex

and multifactorial.91 Atherosclerosis is the major threat to the macrovasculature for patients

with and without diabetes.92 Cardiovascular disease (CVD) accounts for 50% of diabetes-

associated deaths.93 Women with diabetes and CVD, regardless of menopausal status, have a

four- to sixfold increase in the risk of developing CVD, whereas men with diabetes have a two-

to threefold increased risk of CVD compared to women and men without diabetes.94 In 2002,

a survey of people in the United States with diagnosed diabetes found that, surprisingly, 68%

of patients did not consider themselves at risk for heart attack or stroke.95 Ogbera and

44

colleagues reported that Cerebrovascular Accidents (CVA) had one of the highest case fatality

rates of 25%.96Timely and accurate diagnosis can lead to appropriate preventive and

therapeutic interventions and lower mortality rates.96

2.1.7 MANAGEMENT

Type 2 diabetes is not a particularly well-managed disease, with fewer than 50% of patients

meeting glycaemic targets, even in developed countries. More disturbingly, fewer than 10%

achieve glycaemic, lipid and blood pressure targets, despite evidence that multifactorial

interventions are extremely effective at improving morbidity and mortality outcomes.97

Management of diabetes in Nigeria is suboptimal with poor outcomes.16 There is a need for

improved management of diabetes in Nigeria.98

The overall goal of diabetes management is to help individuals with diabetes and their families

gain the necessary knowledge life skills, resources, and support them to achieve optimal health.

This is especially important as 95 % of diabetes care is provided by people with diabetes

themselves, and their families. Diabetes management is improved by: Early diagnosis,

prevention, prompt treatment, promotion of self-care practices and empowerment of people

with diabetes and reduction of the personal, family and societal burden of diabetes.90

A complete medical evaluation is performed to classify the diabetes, detect the presence of

diabetes complications.90 Diabetic history, both recent and historical. Symptoms of potential

complications are assessed. Also important is the social history such as level of exercise, type

of diet, smoking history, use of alcohol and recreational drugs. Important physical

examinations include weight, height and body mass index (BMI). Examination of the feet (for

ulcers and loss of sensation), blood pressure measurement, examination of peripheral pulses

and fundoscopy is also an essential part of assessment. Previous treatment and glycaemic

control in patients with established diabetes should be reviewed and patients assisted in

45

formulating a management plan . Laboratory tests appropriate to the evaluation of each

patient’s medical condition are usually done. Record-keeping is important to ensure good

quality of care and for follow-up and monitoring.11,90

Management of Type 2 diabetes entails the following components:11,90

1. Treatment of hyperglycaemia

Non –pharmacological which involves lifestyle modification through:

Education

Diet

Physical activity

Pharmacological

Oral glucose lowering agents(oral hypoglycaemic agents)

Insulin

Combination Therapies - Oral glucose lowering agents and insulin

2. Treatment of hypertension and dyslipidaemias

3. Prevention and treatment of microvascular complications

4. Prevention and treatment of macrovascular complications

2.1.7.1 Non-pharmacological

Diabetes education is the provision of knowledge and skill to people with diabetes that will

empower them to render self-care in the management of their diabetes and associated disorders.

This is one of the cornerstones of management together with diet, physical activity and

pharmacotherapy, and is critical in improving the outcome.90

Diet

46

Dietary modification is one of the cornerstones of diabetes management, and is based on the

principle of healthy eating in context of social, cultural and psychological influences of food

choices. Dietary modification and increasing level of physical activity are the first steps in the

management of newly diagnosed people with Type 2 diabetes, and have to be maintained. All

members of the diabetes-care team must have knowledge about nutrition to be able to educate

people with diabetes about dietary measures. Dietary counseling is best given by a dietitian or

nutritionist with an interest in diabetes mellitus.90,99 To achieve ideal weight loss, an

appropriate diet is prescribed together with an exercise regimen. Caloric restrictions are

moderate and provide a balanced nutrition. Patients are advised to eat at least three meals a day

and binge eating avoided. The diet is individualized, based on traditional eating patterns

ensuring it is palatable and affordable. Animal fat, salt and pure (simple) sugars in foods and

drinks are discouraged. And food, higher in complex carbohydrates (starches) and fibre

content, vegetables and limited numbers of fruits encouraged. It is essential that simple

explained and written dietary instructions are provided. Patients are advised to measure food

quantities in volumes using available household items, such as cups, or count them in, such as

number of fruits or slices of yam or bread.99 Patients are advised to avoid alcohol. Dietary

modification can reduce HbA1c by 1-2%, depending on the duration of diabetes.11

Physical activity and exercise.

Physical activity or exercise is one of the essentials in the prevention and management of Type

2 diabetes mellitus. Regular physical activity improves metabolic control, increases insulin

sensitivity, improves cardiovascular health, and helps weight loss and its maintenance, as well

as giving a sense of well-being. There are two main types of physical activity: Aerobic or

endurance exercise (e.g. walking or running) and anaerobic or resistance exercise (e.g. lifting

weights). Both types of activity are prescribed to persons with Type 2 diabetes mellitus, but

the aerobic form is usually preferred. Patients are encouraged to integrate increased physical

47

activity into their daily routine.90 People with type 2 diabetes are advised to perform at least

150 minutes per week of moderate intensity aerobic physical activity (50-70% of maximum

heart rate). Randomised, controlled trials have demonstrated that physical activity combined

with dietary changes can delay the progression of impaired glucose tolerance to type 2 diabetes.

In patients with established type 2 diabetes, regular physical activity significantly improves

glycaemic control and reduces cardiovascular risk factors, and may reduce chronic medication

dosages.100 Regular physical activity may also improve symptoms of depression and improve

health-related quality of life. Structured exercise interventions of at least 8 weeks’ duration

have been shown to lower HbA1c by an average of 0.66% in people with type 2 diabetes, even

with no significant change in BMI.101

2.1.7.2 Pharmacological Management

Up to now, many kinds of anti-diabetic medicines have been developed for

the patients and most of them are chemical or biochemical agents aiming at controlling blood

glucose. Despite the impressive advances in health sciences and medical care, there are many

patients who use alternative therapies alone or complementary to the prescribed medication.

Traditional plant remedies or herbal formulations exist from ancient times and are still widely

used to treat hypoglycemic and hyperglycemic conditions all over the world, despite all the

controversy concerning their efficacy and safety.104 It must be noted that many ethno-botanical

surveys on medicinal plants used by the local population have been performed in different parts

of the world and there is a considerable number of plants described as anti-diabetic. Some of

48

the anti-diabetic medicinal plants in use include; Viscum album (mistletoe), Abelmoschus

moschatus (Malvaceae), Acacia arabica (Leguminoseae), Azadirachta indica (Meliaceae),

Abroma augusta(Sterculiaceae), Acer ginnala (Aceraceae), Illicium religiosum (Illiciaceae),

Cornus macrophylla (Cornaceae) and Achyranthes aspera L. (Amaranthaceae). In addition a

variety of compounds have been isolated (alkaloids, glycosides, terpenes, flovonoids, etc) but

further studies need to be done for these to be used as clinically useful medicines. Metformin

(a biguanide), is a derivative of an active natural product, galegine, isolated from the plant

Galega officinalis L. It is the only drug derived from a plant that is approved for use in the

treatment of type 2 diabetes mellitus.104

Oral Glucose Lowering Agents (OGLAs)

These were previously referred to as oral hypoglycaemic agents. Oral pharmacotherapy is

indicated when an individuals glycaemia targets are not met by the combination of dietary

modifications and physical activity/exercise. In some cases, oral pharmacotherapy or insulin is

indicated at the first presentation of diabetes, i.e. a fasting blood glucose level > 11mmol/L or

random blood glucose level > 15 mmol/L.11,90,102,103

Choice of Oral Glucose Lowering Agents (OGLA)

The use of low cost proven effective generic drugs instead of proprietary brands, which are

usually expensive is encouraged. The choice of OGLAs depends on the patient’s

characteristics, lifestyle, degree of glycaemic control, access to drugs, economic status and

mutual agreement between the doctor and the person with diabetes.88 The sulphonylureas and

metformin are the agents most widely available. Monotherapy with any of the drugs is the

initial choice. Use of the stepped-care approach is recommended, as monotherapy is seldom

sufficient, because of the progressive nature of the disease. Combination therapy is considered

as initial choice if HbAIC is greater than 8 %88. Yussuff and colleagues in Ibadan showed that

49

Oral Hypoglycaemic Agents (OHA) were prescribed for 86% of patients while insulin and

OHA was prescribed in 14%. About 70.8%) of patients on OHA were on combination therapy.

The most frequently prescribed OHA combination was glibenclamide and metformin (95.8%).

Only 44% of patients had adequate glycaemic control.103 Another study in Ibadan showed that

biguanides (66%) are the commonest oral hypoglycaemic prescribed.104 The clinical trials, in

concert with epidemiological data support decreasing glycaemia as an effective means of

reducing long-term microvascular and neuropathic complications. Typically, metformin

monotherapy will lower HbA1c levels by 1.5 %. The United Kingdom Prospective Diabetes

Study (UKPDS) demonstrated a beneficial effect of metformin therapy on CVD outcomes

which needs to be confirmed.105 Prospective randomised trials have documented reduced rates

of microvascular complications in type 2 diabetic patients treated to lower glycaemic target.

Finally, a meta-analysis of cardiovascular outcomes in these trials suggested that every HbA1c

reduction of ~1% may be associated with a 15% relative risk reduction in non-fatal myocardial

infarction, but without benefits on stroke or mortality.106 The glucose-lowering effectiveness

of non-insulin pharmacological agents is said to be high for metformin, sulfonylureas, TZDs

and GLP-1 agonists (expected HbA1c reduction ~1.0–1.5%) and generally lower for

meglitinides, DPP-4 inhibitors, AGIs, colesevelam and bromocriptine (~0.5–1.0%).90

Precautions: Metformin is the first choice in overweight patients. Thiazolidinediones may be

used when Metformin is contraindicated. Long-acting sulphonylureas are avoided in elderly

patients. In such patients, short-acting sulphonylureas such as glimepiride, gliclazide are used.

Metformin is contraindicated in people with elevated serum creatinine, liver disease and severe

respiratory, cardiac and peripheral vascular disease. Combination therapy using OGLAs with

different mechanisms of action is indicated if monotherapy with one of the agents has

failed.88,98 Two drugs from the same class are not used.

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The rapid acting secretagogues (glitinides) and the alpha glucosidase inhibitors allow for

flexibility in the glycaemic management but are relatively expensive. When oral combination

therapy fails, insulin is added to the treatment regimen or the OGLAs replaced. Three-drug

combination therapy can be used when two-drug regimens fail to achieve target values.

However, such regimens are very expensive and difficult to manage. Such patients should be

referred to a specialist. Use of combination therapy often results in an increased number of

tablets to be taken and creates new adherence problems. Fixed combination therapies inhibit

flexibility in dosing prescription.

Insulin Therapy

Indications for use of insulin in type 2 diabetes

Initial presentation with severe hyperglycaemia and are symptomatic

Presentation in hyperglycaemic emergency

Peri-operative period especially major or emergency surgery

Other medical conditions requiring tight glycaemic control e. g acute MIs, strokes,

sepsis

Organ failure (e.g. renal, liver, heart)

Pregnancy

Latent autoimmune diabetes of adults (LADA)

Contraindications to OGLAs

Failure to meet glycaemic targets with OGLAs

Supplemental Therapy:

Intermediate acting (NPH) insulin is given as a Total Daily Dose calculated by: Kg x 0.2 IU of

insulin (70 kg patient x 0.2 IU = 14IU insulin). The OGLAs are continued (half maximum dose

of sulphonylureas and metformin dose of 2 g/day, or the sulphonylureas stopped and metformin

continued). Blood glucose levels monitored.11,90,102

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Substitution Therapy:

OGLAs are discontinued (unless the patient is obese where metformin will be continued), and

a pre-mixed insulin is introduced twice daily at a dosage of 0.2 IU/kg body weight. This is split

into 2/3 in the morning and 1/3 in the evening, at 30 minutes before the morning and the

evening meals. If the requirement of insulin exceeds 30 units/day, referral should be

considered.90

2.1.7.3 Management of Co-Morbidities in Type 2 Diabetes Mellitus

Hypertension11,90.107

Hypertension is a common co-morbidity of diabetes, affecting the majority of patient. The

diagnostic cut-off for a diagnosis of hypertension is lower in people with diabetes (blood

pressure of 130/80) than those without diabetes (blood pressure of140/90 mmHg) due to

synergistic risks of hypertension and diabetes.11 Epidemiologic analyses show that blood

pressure values of 115/75mmHg and below are associated with increased cardiovascular event

rates and mortality in individuals with diabetes.11 Randomized clinical trials have demonstrated

the benefit (reduction in CHD events, stroke, and nephropathy) of lowering blood pressure to

140 mmHg systolic and 80 mmHg diastolic in individuals with diabetes.107

Management of hypertension should be integrated with that of diabetes, starting with education

lifestyle modifications (physical exercise, diet and weight loss) and setting goals. Lifestyle

therapy for hypertension consists of: weight loss, if overweight; Dietary Approaches to Stop

Hypertension (DASH)-style dietary pattern including reducing sodium and increasing

potassium intake; vegetables (8 –10 servings/day), and low-fat dairy products (2–3

servings/day); avoiding excessive alcohol consumption moderation of alcohol intake; and

increased physical activity.11,108 Pharmacologic therapy for patients with diabetes and

hypertension is a regimen that includes either an ACE inhibitor or an ARB. If one class is not

52

tolerated, the other is substituted. Multiple drug therapy (two or more agents at maximal doses)

is generally required to achieve blood pressure targets. When ACE inhibitors, ARBs, or

diuretics are used, kidney function and serum potassium levels are monitored.11

Diabetes and other Cardiovascular Diseases

Annual assessment is recommended for cardiovascular risk factors. Evaluation for coronary

artery disease includes ECG, X-ray of the chest (in people with breathlessness) and if warranted

an echocardiogram, stress test and coronary angiography is done. Evaluation for

Cerebrovascular disease includes carotid Doppler and carotid angiography. Doppler and

angiography of the lower limbs is used to evaluate for peripheral vascular disease.90,108,109

Lipids disorders in Diabetes

The risk of coronary artery disease and other macrovascular disorders is two to five times

higher in people with diabetes than in non-diabetic subjects and increases in parallel with the

degree of dyslipidaemia. Lipids are assessed annually if normal, and if abnormal or on

treatment; every three to six months. Non-pharmacological is the initial treatment for six

months. Statins are used for raised LDLC, fibrates for raised triglycerides, nicotinic acid or

fibrates for low HDLC.100 For diabetic patients: with overt CVD and without CVD who are

over age 40 years with one or more other CVD risk factors ;statin therapy is recommended

regardless of baseline lipid levels.11

Antiplatelet agents

Aspirin therapy (75–162 mg/day) is considered as a primary prevention strategy in those with

type 1 or type 2 diabetes at increased cardiovascular risk. This includes most men 50 years of

age or women 60 years of age who have at least one additional major risk factor (family history

of CVD, hypertension, smoking, dyslipidemia, or albuminuria). It can be as a secondary

53

prevention strategy in those with diabetes with a history of CVD. For patients with CVD and

documented aspirin allergy, clopidogrel (75mg/day) is recommended.11

Smoking cessation

All patients are advised not to smoke. Smoking cessation counseling and other forms of

treatment is a component of diabetes care. 11

2.1.7.4 Management of Complications of diabetes

Hyperglycaemic Emergencies

The stress of illness, trauma, and/or surgery frequently aggravates glycaemic control and may

precipitate diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state, life-threatening

conditions that require immediate medical care to prevent complications and death. Marked

hyperglycaemia requires temporary adjustment of the treatment. The patient treated with

noninsulin therapies or MNT alone may temporarily require insulin. Adequate fluid and caloric

intake must be assured. In the setting of severely uncontrolled diabetes with catabolism, defined

as fasting plasma glucose levels of 13.9 mmol/l (250 mg/dl), random glucose levels

consistently above 16.7 mmol/l (300 mg/dl), A1C above 10%, or the presence of ketonuria, or

as symptomatic diabetes with polyuria, polydipsia and weight loss, insulin therapy in

combination with lifestyle intervention is the treatment of choice. Insulin is titrated rapidly and

is associated with the greatest likelihood of returning glucose levels rapidly to target levels.

After symptoms are relieved and glucose levels decreased, oral agents can often be added and

it may be possible to withdraw insulin.11

Hypoglycemia

Glucose (15–20 g) is the preferred treatment for the conscious individual with hypoglycemia,

although any form of carbohydrate that contains glucose may be used. Once glucose returns to

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normal, the individual should consume a meal or snack to prevent recurrence of

hypoglycemia.11,90

Glucagon should be prescribed for all individuals at significant risk of severe hypoglycemia,

and caregivers or family members of these individuals should be instructed in its

administration. Glucagon administration is not limited to health care professionals. Individuals

with hypoglycemia unawareness or one or more episodes of severe hypoglycemia should be

advised to raise their glycaemic targets to strictly avoid further hypoglycemia for at least

several weeks, to partially reverse hypoglycemia unawareness and reduce risk of future

episodes.11

Microvascular complications mainly involve the kidney, eyes, lower extremities and nerves.

These complications can be prevented or their progression delayed by optimal treatment of

hyperglycaemia and hypertension. Screening for the complications and prompt interventions

reduce the risk of major outcomes such as blindness and leg amputations.11

Diabetic nephropathy

Patients with clinical nephropathy almost always have retinopathy and coronary artery disease.

Numerous interventions are appropriate at different stages of renal function in order to prevent

or slow the progression of renal disease and associated cardiovascular disease. Improved

glucose control at any stage of renal function reduces renal disease progression. ACE inhibitor

or ARB should be used in all non-pregnant patients with micro or macroalbuminuria. For

patients with type 2 diabetes mellitus, ACE inhibitors or ARBs can reduce progression of

macrovascular complications.11,110

Diabetic Neuropathy

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Peripheral neuropathy is difficult to prevent and treat. Most patients with type 2 diabetes and

peripheral neuropathy have few symptoms. Good glycaemic control should be the first control

to symptomatic neuropathy. For those patients with painful neuropathy treatment choices

include: antidepressants such as the tricyclics or vanticonvulsants (gabapentin, pregablin)

topical treatment with capsaicin. Aggressive daily foot care, inspection of the feet at every

office visit is recommended. Early treatment of foot infections, treatment of callus, use of

moisturizing lotion and proper footwear may forestall problems, including amputation.

Vascular surgery may also prevent amputation in some patients with established severe

peripheral vascular disease Proper high-risk foot management is necessary to prevent

ulceration and amputation. Patients with claudication and/or absent pedal pulses should be

referred to vascular surgery.11,110

Diabetic Retinopathy

Screening for diabetic retinopathy saves vision at a relatively low cost. In fact, screening costs

may be less than the costs of disability payments for those who become blind. Laser

photocoagulation surgery is effective in preventing visual loss in diabetic retinopathy.

Treatment includes glycaemic and blood pressure control. Periodic screening and dilated eye

exams by an eye specialist and early treatment of diabetic retinopathy can prevent visual

loss.11,110 The ADA recommends an initial eye exam for those who have type 1 diabetes within

five years of diagnosis and shortly after diagnosis for those who have type 2 diabetes.

Thereafter, nearly all patients with diabetes should have annual exams, and more often if

retinopathy is progressing.11

2.1.7.5 Psychosocial assessment and care

Assessment of psychological and social situation should be included as an ongoing part of the

medical management of diabetes. Psychosocial screening and follow-up should include, but is

not limited to, attitudes about the illness, expectations for medical management and outcomes,

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affect/mood, general and diabetes- related quality of life, resources (financial, social, and

emotional), and psychiatric history. Referral to appropriate services should be done when

necessary. Psychological and social problems can impair the individual’s or family’s ability to

carry out diabetes care tasks and therefore compromise health status.

2.2 GLYCAEMIC CONTROL

2.2.1 Assessment of Glycaemic Control

Two primary techniques are available for health providers and patients to assess the

effectiveness of the management plan on glycemic control: patient self-monitoring of blood

glucose (SMBG) or interstitial glucose and glycated haemoglobin.

2.2.1.1 Glucose Monitoring

Self-monitoring of blood glucose (SMBG) is an important component of modern therapy for

diabetes mellitus. SMBG is recommended for people with diabetes and their health care

professionals in order to achieve a specific level of glycaemic control and to prevent

hypoglycaemia. The goal of SMBG is to collect detailed information about blood glucose

levels at many time points to enable maintenance of a more constant glucose level by more

precise regimens. It can be used to aid in the adjustment of a therapeutic regimen in response

to blood glucose values and to help individuals adjust their dietary intake, physical activity,

and insulin doses to improve glycaemic control on a day-to-day basis.111 SMBG may be useful

as a guide to the success of therapy.20 Studies clearly demonstrate that frequent SMBG

improves A1c and related outcomes in T1DM and T2DM regardless of the therapy used.112

SMBG helps protect patients by allowing them to immediately confirm hypoglycemia and

hyperglycaemia. Further, SMBG facilitates diabetes self-management education and motivates

57

patients to live healthier lives.113 Other studies, however, have suggested that SMBG has not

achieved its true potential impact as an aid to improving glycemic control.113

A meta-analysis of SMBG in non–insulin-treated patients with type 2 diabetes concluded that

some regimen of SMBG was associated with a reduction in A1C of 0.4%.114 However, many

of the studies in this analysis also included patient education with diet and exercise counseling

and, in some cases pharmacologic intervention, making it difficult to assess the contribution of

SMBG alone to improved control.115 Several recent trials have called into question the clinical

utility and cost-effectiveness of routine SMBG in non–insulin-treated patients.116,117,118

Because the accuracy of SMBG is instrument and user dependent,119 evaluation of each

patient’s monitoring technique is important, both initially and at regular intervals thereafter. In

addition, optimal use of SMBG requires proper interpretation of the data. Patients need to be

taught how to use the data to adjust food intake, exercise, or pharmacological therapy to achieve

specific glycaemic goals, and these skills reevaluated periodically. Other factors that inhibit

testing frequency include pain, and inconvenience.114 All of these factors work against seeing

a benefit in T2DM patients.114

In Nigeria, self-monitoring isn’t practised routinely. Most patients’ do not own a glucose

meter.120 Glucose monitoring is usually done by measurement of fasting plasma glucose at the

hospital on appointment days.120 A fasting or preprandial target of 4.0-7.0 mmol/l is

recommended.11 Unachukwu and colleagues in a tertiary hospital in Portharcourt showed that

though 96% of patients knew about SMBG, only 27% owned glucose meters and this was likely

to be due to financial reasons.120 However, the income level of the patients was not assessed

and the study was carried out in an urban setting so might not be representative of the entire

population. The study also showed that frequency of monitoring was quite poor among those

who used their meters with only six of them monitoring at least once a day.120 In another study

in UCH, SMBG use was found to be extremely low as more than two-third of the respondents

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were not aware of SMBG for regular and prompt detection of fluctuations in their blood glucose

levels.104

In developed countries with well-established health systems, owning a glucose meter for

diabetic patients is the rule, rather than the exception. However in resource-poor settings this

is hardly the case. Financial support for SBGM in Africa remains a major barrier to improved

blood glucose control, both in type 1 and type 2 diabetic patients.120

Continuous glucose monitoring (CGM) through the measurement of interstitial glucose (which

correlates well with plasma glucose) is available. These sensors require calibration with

SMBG, and the latter are still recommended for making acute treatment decisions. CGM may

be particularly useful in those with hypoglycemia unawareness and/or frequent episodes of

hypoglycemia, and studies in this area are ongoing.11

2.2.1.2 Glycated Haemoglobin

Glycated haemoglobin has been the key measure of glycaemic control in diabetic patients for

last two decades. It is considered to be the gold standard test, and most widely accepted test of

glycaemia among clinicians and patients. The glycated Hb concentration levels are also more

closely related to the risk of chronic complications than random single or episodic glucose

levels.121

Glycated hemoglobin (HbA1c) expressed as a percentage of total blood hemoglobin

concentration gives a good retrospective assessment of the mean plasma glucose concentration

during the preceding eight to 12 weeks.122 while the recent glycaemic level has the highest

influence and the preceding 30 days contribute only up to 50%.123

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It can be performed at any time of the day and does not require any special preparation such

as fasting. These properties have made it the preferred test for assessing glycaemic control in

people with diabetes.122

Because HbA1c is thought to reflect average glycaemia over several months,119 and has strong

predictive value for diabetes complications,124 HbA1c testing should be performed routinely

in all patients with diabetes, at initial assessment and then as part of continuing care.

Measurement approximately every 3 months determines whether a patient’s glycaemic targets

have been reached and maintained. For any individual patient, the frequency of HbA1c testing

is dependent on the clinical situation, the treatment regimen used, and the judgment of the

clinician. Some patients with stable glycaemia well within target may do well with testing only

twice per year, while unstable or highly intensively managed patients (e.g., pregnant type

1women) may be tested more frequently than every 3 months. The availability of the HbA1c

result at the time that the patient is seen (point-of-care testing) has been reported to result in

increased intensification of therapy and improvement in glycemic control.125 The HbA1c test is

subject to certain limitations. Conditions that affect erythrocyte turnover (hemolysis, blood

loss) and hemoglobin variants must be considered, particularly when the HbA1c result does not

correlate with the patient’s clinical situation.119 In addition, HbA1c does not provide a measure

of glycaemic variability or hypoglycemia. For patients prone to glycaemic variability

(especially type 1 patients, or type 2 patients with severe insulin deficiency), glycemic control

is best judged by the combination of results of SMBG testing and the HbA1c The HbA1c may

also serve as a check on the accuracy of the patient’s meter (or the patient’s reported SMBG

results) and the adequacy of the SMBG testing schedule. The HbA1c has several advantages

to the FPG and OGTT, including greater convenience, since fasting is not required; evidence

to suggest greater pre-analytical stability; and less day-to-day perturbations during periods of

stress and illness. These advantages must be balanced by greater cost, the limited availability

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of HbA1c testing in certain regions of the developing world, and the incomplete correlation

between HbA1c and average glucose in certain individuals.

Other measures of chronic glycaemia such as fructosamine are available, but their linkage to

average glucose and their prognostic significance are not as clear as is the case for HbA1c.20

Even though HbA 1c is the most acceptable measure of chronic glycemia. It is not widely

available and/or affordable in Nigeria.126

2.2.2 Glycaemic Goals in Adults

Control of glycaemia is a priority in diabetes management, and is reflected in target values for

HbA1c level endorsed by professional organizations. The glycaemic goal recommended by the

American diabetes association, selected on the basis of practicality and the projected reduction

in complications over time is, in general, an HbA1c level of < 7%.127 The American Diabetes

Association (ADA) recommended a goal of HbA1c < 6.0% in individuals to the extent that, it

can be achieved without such adverse effects as hypoglycemia, with a population goal of <

7.0%.11 Preprandial capillary plasma glucose 70–130 mg/dl (3.9–7.2 mmol/l) and Peak

postprandial capillary plasma glucose of 180 mg/dl (10.0 mmol/l) are also recommended.

Goals are individualized based on duration of diabetes, age/life expectancy, comorbid

conditions, known CVD or advanced microvascular complications, hypoglycemia

unawareness and individual patient considerations. Postprandial glucose may be targeted if

HbA1c goals are not met despite reaching preprandial glucose goals. Postprandial glucose

measurement is made one to two hours after the beginning of the meal.11

Lowering HbA1c to below or around 7% has been shown to reduce microvascular and

neuropathic complications of diabetes and, if implemented soon after with long-term reduction

in macrovascular disease.11 Because additional analyses from several randomized trials suggest

a small but incremental benefit in microvascular outcomes with HbA1c values closer to normal,

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providers might reasonably suggest more stringent HbA1c goals for selected individual

patients, if this can be achieved without significant hypoglycemia or other adverse effects of

treatment. Such patients might include those with short duration of diabetes, long life

expectancy, and no significant CVD. Conversely, less stringent HbA1c goals may be

appropriate for patients with a history of severe hypoglycemia, limited life expectancy,

advanced microvascular or macrovascular complications, extensive comorbid conditions, and

those with longstanding diabetes in whom the general goal is difficult to attain despite DSME,

appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents

including insulin.11 Glycaemic control is fundamental to the management of diabetes.

Landmark RCTs have demonstrated that meticulous glycaemic control reduces risk of

microvascular and neurological complications of diabetes. Studies in prediabetes have shown

that early intervention slows progression to diabetes.11 Presently, HbA1c is the most acceptable

and widely used measure of chronic glycemia.119 Elevated HbA1c levels have been associated

with long-term complications of diabetes mellitus.11 Its level is therefore used to determine

whether treatment is adequate. Many Nigerians with diabetes mellitus do not achieve good long

term glycaemic control when HbA1c is used as an index of chronic glycaemia. Idogun and

Olumese 128reported that only 53% of 64 type 2 diabetic patients seen in a tertiary medical

centre in Benin City had good glycaemic control. Adebisi and colleagues129 found only 36%

of diabetic patients had a HbA1c ≤7.2% in Ilorin.128 Another study done in Benin showed that

35% of patients had good long-term glycaemic control of the diabetes mellitus. These studies

however are cross-sectional and the sample sizes small.

2.2.3 Measurement of Glycated Haemoglobin

Glycated haemoglobin is formed by non-enzymatic interaction between glucose and the amino

groups of the valine and lysine residues of the N-terminus of beta chain of haemoglobin. This

represents a reliable average of blood glucose over preceding three months.121 Formation of

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glycohaemoglobin is irreversible and the level in the red blood cell depends on the blood

glucose concentration. The method used in measurement of HbA1c should be standardized to

Diabetes Control and Complication Trial (DCCT) reference assay or the National

Glycohaemoglobin Standardisation Programme (NGSP) certified method.130 Different Lab

techniques and many clinical conditions may result in under-estimation or over-estimation of

HbA1c.121 There are currently four different assay principles (ion-exchange chromatography,

electrophoresis, affinity chromatography and immunoassay) and approximately 20 different

methods used to measure glycohaemoglobin which measure different glycated products, report

different units and which can produce numerically different results for the same specimen.

Standardisation, which will lead to all assays reporting results in a standard unit, % HbA1c, is

recommended. The liquid chromatography ionic exchange using high performance liquid

chromatography (HPLC) is now the most reliable methodology. It is based on the difference in

electric charge and has numerous advantages. It is completely automatic and presents an

excellent reproducibility in different laboratories. It allows to measure with precision all sub-

fractions of HbA1c and anomalous haemoglobin. Its cost is high and it is not available in all

the laboratories.131 The immunochemical method DCA 2000 is the most popular and utilizes

antigenic properties. It is based on a latex immunoagglutination inhibition methodology. This

is the method used in this study. It allows to dose the HbA1c in 6 minutes, it requires a small

amount of blood (1 microliter), it is done with sample of capillary blood, it presents a strict

correlation (r=97) with the high performance liquid chromatography (HPLC) method.132 It is a

certified method for the analysis of glycated haemoglobin.

Both methods (the HPLC and immunochemical method) are standardized for HbA1c assay.

They are certified by the National Glyco-haemoglobin Standardization Program (NGSP) as

traceable to and standardized against the Diabetes Control and Complications Trial (DCCT)

reference method.11

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2.3 SELF MANAGEMENT BEHAVIOUR

Self-management is the cornerstone of good diabetes care; more than 95 percent of diabetes

care is carried out by patients themselves.133 Self- management includes behaviours such as

healthy eating, being active, blood glucose monitoring, taking medication, problem solving,

reducing risks, and healthy coping.134 These are the seven specific self-care behaviors

developed by the American Association of Diabetes Educators, known collectively as the

AADE7™ which have are defined to guide the process of diabetic self-management education

and training (DSME/T) and helps patients achieve behaviour change.135 Facilitating positive

self-care behaviors directed at successful diabetes self-management is a desired outcome of

DSME/T.136

2.3.1 Healthy Eating

Making healthy food choices, understanding portion sizes and learning the best times to eat are

central to managing diabetes. By making appropriate food selections, children and teenagers

grow and develop as they would if they didn’t have diabetes. And, by controlling their weight,

many adults may be able to manage their condition for a time without medications. Diabetes

self-management education can assist people with diabetes gain knowledge about the effect of

food on blood glucose, sources of carbohydrates and fat, appropriate meal planning and

resources to assist in making food choices. Skills taught include reading labels, planning and

preparing meals, measuring foods for portion control, fat control and carbohydrate counting.

Barriers, such as environmental triggers like diet and exercise, emotional, financial, and

cultural factors, are also addressed.134 There is now good evidence to show the benefits of

healthy eating for people with diabetes. These include: improvement in glycaemic control and

lipid profiles, maintenance of blood pressure in the target range, and weight loss or

maintenance.137-9 Because there is no one set of nutrition recommendations or intervention that

64

apply to all persons with diabetes. Nutrition and education should begin with an assessment of

each individual’s current eating habits and preferences.134

2.3.2 Being Active

Regular activity is important for overall fitness, weight management and blood glucose

control. With appropriate levels of exercise, those at risk for type 2 diabetes can reduce that

risk, and those with diabetes can improve glycaemic control. Being active can also help

improve body mass index, enhance weight loss, help control lipids and blood pressure, and

reduce stress. Diabetes educators and their patients collaborate to address barriers, such as

physical, environmental, psychological, and time limitations. Developing an appropriate

activity plan that balances food and medication with the activity level is essential. Exercise is

important in both type 1 and type 2 diabetes.140 For persons with type 2 diabetes, engaging in

regular exercise may improve glycaemic control and reduce the risk of microvascular and

macrovascular complications, increase insulin sensitivity, reduce stress and depression,

contribute to weight loss/maintenance,135 and contribute to control of lipids and blood pressure,

thereby reducing the risk of cardiovascular disease, which is the leading cause of death in

persons with diabetes.134,140-2

2.3.3 Monitoring

Daily self-monitoring of blood glucose provides people with diabetes the information they

need to assess how food, physical activity, and medications affect their blood glucose levels.

Patients should be instructed about equipment choice and selection, timing and frequency of

testing, target values, and interpretation and use of results. Self-monitoring may include such

assessments as blood glucose levels, blood pressure, foot checks, steps walked, weight, and

achievement of goals.143-4 Self-monitoring behaviors aim to prevent or slow the progression of

diabetes complications. Information and instruction on self-monitoring for foot care will

65

promote self-care and reduce complications.144-5 Blood pressure monitoring is effective in

detecting and helping to control hypertension, which is a major risk factor for cardiovascular

and cerebral vascular disease and microvascular complications.144Self-monitoring of blood

glucose (SMBG) is a tool that guides glycaemic management strategies and has the potential

to improve problem-solving and decision-making skills for persons with diabetes and their

healthcare providers. SMBG can promote improved understanding of the impact of foods,

physical activity, and medications on blood glucose levels. It can facilitate more timely

adjustment of therapeutic regimens, and support flexibility in meal planning, physical activity,

and medication administration.143-4

2.3.4 Taking Medication

Diabetes is a progressive condition.134 Effective drug therapy in combination with healthy

lifestyle choices, can lower blood glucose levels, reduce the risk for diabetes complications,

and produce other clinical benefits.145 The goal is for the patient to be knowledgeable about

each medication, including its action, side effects, efficacy, toxicity, prescribed dosage,

appropriate timing and frequency of administration, effect of missed and delayed doses, and

instructions for storage, travel, and safety. The value of pharmacologic therapy in achieving

and maintaining diabetes control has been clearly established. In addition to investigating

pharmacotherapy and improved A1C, well-designed trials have explored the benefit of

pharmacologic therapy in improving avoidable and costly microvascular and macrovascular

outcomes of diabetes. 146,147,148

2.3.5 Problem Solving

A person with diabetes must keep their problem-solving skills sharp because on any given day,

a high or low blood glucose episode or a sick day will require them to make rapid, informed

decisions about food, activity, and medications. This skill is continuously put to use because

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even after decades of living with the disease, stability is never fully attained; the disease is

progressive, chronic complications emerge, life situations change, and the patient is aging.

Collaboratively, diabetes educators and patients address barriers, such as physical, emotional,

cognitive, and financial obstacles and develop coping strategies. Problem solving is a strategy

that has been used to facilitate patients' attainment of each of the other self-management

behaviors (healthy eating, being active, taking medications, monitoring, healthy coping, and

reducing risks).134 Problem solving is defined as "a learned behavior that includes generating a

set of potential strategies for problem resolution, selecting the most appropriate strategy,

applying the strategy, and evaluating the effectiveness of the strategy."135

Problem solving is most commonly characterized as involving a sequence of rational steps, and

it is recognized as a core component of effective diabetes self-management.147-9 Some evidence

associates low levels of problem solving with poor glycaemic outcomes. Overall, the evidence

suggests that problem solving training may be an effective intervention tool for select

outcomes.148-9 More studies are needed to elucidate mechanisms of action and optimal

approaches to standardizing assessment and intervention.134

2.3.6 Healthy Coping

An important part of the diabetes education is identifying the individual’s motivation to change

behavior, then helping set achievable behavioral goals and guiding the patient through multiple

obstacles. Patients can be supported by encouraging them to talk about their concerns and fears

and this can help them learn what they can control and offer ways for them to cope with what

they cannot. Health status and quality of life are affected by cognitive, emotional, social, and

situational factors. Psychological distress may directly affect physiological aspects of health

and indirectly influence a person’s thoughts, motivation to keep his or her diabetes in control,

and healthcare behaviors. When motivation is dampened, the commitment to and behavioral

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steps required for effective self-care are difficult to maintain. When barriers seem

insurmountable, good intentions alone cannot sustain the behavior.150 Coping efforts may

become difficult and, in turn, a person's ability to self-manage his or her diabetes may

deteriorate.151-3 The literature also has demonstrated the benefits of interventions to promote

healthy coping on metabolic control.151-4

2.3.7 Reducing Risks

Effective risk reduction behaviors such as smoking cessation and regular eye, foot, and dental

examinations reduce diabetes complications and maximize health and quality of life. An

important part of self-care is learning to understand, seek, and regularly obtain an array of

preventive services. Assisting patients in gaining knowledge about standards of care,

therapeutic goals, and preventive care services to decrease risks is essential. Reducing risks is

defined as implementing effective risk reduction behaviors to prevent or slow the progression

of diabetes complications.11,155-7

Diabetes care processes and outcomes have improved over the past 10 years, but in one study,

only approximately 7% of persons with diabetes had achieved established goals for glycaemic

control, blood pressure, and lipids.158 The following skills need to be taught to people with

diabetes as interventions that reduce diabetes complications and maximize health and quality

of life: smoking cessation, foot checks, blood pressure monitoring, self-monitoring of blood

glucose, maintenance of personal care records, and regular eye, foot, and dental

examinations.134

2.4 TRADITIONAL MODEL OF CARE

2.4.1 Overview

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Today’s medical system is optimized for the delivery of acute, episodic care by individual

physicians.159,160 This paradigm, referred to here as the traditional medical model, views the

physician as responsible for diagnosing the illness, deciding on an appropriate treatment, and

ensuring that that treatment is carried out as prescribed.The physician is then in charge of, and

responsible for, treatment of the illness.161,162 It is disease centred and based on the bio-medical

theory of disease.163 It explains the patient’s symptoms from a pathophysiological point of

view.162 Treatment of acute illness remains the dominant paradigm in the training and,

subsequently, in the practice of medicine.161,162 In this model, the physician is viewed as active,

powerful, knowledgeable, and in control of the care process. The patient is viewed as passive,

accepting, compliant, and dependent on the physician's medical knowledge and goodwill. The

traditional is the dominant paradigm in our health care system, influencing almost all health

care.161

2.4.2 Advantages and Disadvantages

The acute episodic care practised in the Primary care settings in Nigeria while helpful in coping

with busy out-patient clinics is not effective in equipping patients with the self –care skills

which is central to the management of chronic illnesses like diabetes. Patients carry out 95%

or more of the daily self-care of diabetes.161 If such self-care merely involved taking a pill each

morning, this issue might never have arisen, since taking a pill once a day is not nearly as

difficult or intrusive on the patient's life as are many diabetes self-care regimens. In the

traditional model, the professionals are the experts who tell the patient what to do and the

patients are passive. This is not workable in the management of diabetes because diabetes and

its self-care affect virtually every aspect of the patient's life. As a result, patients are often asked

to substantially reshape the way in which they live.161 Traditional patient education imparts

disease specific information and technical skills.161 Mounting evidence indicates that while

such interventions increased knowledge, they are unsuccessful in changing behavior or

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improving disease control and other outcomes while self management education teaches

problem solving skills.2 For some patients, a major benefit of the traditional medical model is

the opportunity for patients to turn over the anxiety inherent in being ill to a physician.164 They

are unable or unwilling to assume a significant decision-making role in the treatment of their

diabetes and would rather have passive roles.164

In traditional health care systems, problems are identified and solved by the professional.

Behaviour change is by external motivation (making changes to please the physician). Patients

are regarded as non-compliant based on physician-defined problems and patient’s failure to

solve them.165 In diabetic care, patients need to be internally motivated to gain understanding

and confidence to accomplish behaviour change. Principally trained in the acute care of

patients, physicians may have inappropriate expectations of the degree to which patients can

change behavior.164 Acute care requires change for a few weeks but in diabetes, patients must

change their behavior for a lifetime.111 Hence the traditional medical model-compliance-

oriented approach is inappropriate and unworkable in the treatment of diabetes.

2.5 CHRONIC CARE MODEL

2.5.1 Overview

Effective management of chronic disease requires scheduled and regular patient visits to clinics

for monitoring disease control, detecting complications, adjusting medications, and negotiating

lifestyle changes.166 The quality of care for diabetes continues to fall short of recommended

guidelines and result regardless of the health care setting or patient populations.167,168 The

increasingly well-documented gap between clinical research findings and practice has spurred

a number of efforts to improve the quality of chronic illness care. It also is apparent that this

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problem cannot be solved by simply trying to do more; instead, fundamental changes are

needed in the way that care is structured and delivered.15 For chronic illness care, this change

entails shifting from medical care that is reactive and event-driven to care that is proactive and

planned.15 Recent models for improving the care of chronic illnesses advocate a

multidisciplinary team dedicated to proactively managing a population of patients. 167

Based on the evidence of these interventions, summarized in a review of Tsai et al, Wagner

and colleagues developed the Chronic Care Model (CCM) as a conceptual framework.13,169

The Chronic Care Model, or CCM is one approach to improving chronic illness care that is

being used increasingly to assess and improve care.15 The CCM is based on evidence-based

practices and reviews of the literature on effective care.

2.5.2 Elements of the CCM

The Chronic Care Model (CCM) includes six core elements for the provision of optimum care

for patients with chronic disease:1) delivery system design (moving from a reactive to a

proactive care delivery system, where planned visits are coordinated through a team-based

approach; 2) self-management support; 3) decision support (basing care on consistent, effective

care guidelines); 4) clinical information systems (using registries that can provide patient-

specific and population based support to the care team); 5) community resources and policies

(identifying or developing resources to support healthy lifestyles); and 6) health systems (to

create a quality-oriented culture).2,15,159,170

High-quality chronic illness care is characterized by productive interactions between practice

team and patients that consistently provide the assessments support for self-management,

optimization of therapy, and follow-up associated with good outcomes. (1) elicit and review

data concerning patients’ perspectives and other critical information about the course and

management of the condition(s); (2) help patients to set goals and solve problems for improved

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self-management; (3) apply clinical and behavioral interventions that prevent complications

and optimize disease control and patient well-being; and (4) ensure continuous follow-up.2

Figure 2.4:The chronic care model.171

2.5.2.1 Health Care Organization

This element provides the structural foundation on which the other elements rely. It requires a

committed leadership and resources. An organization that has the CCM as one of its goal is

essential in its implementation, sustenance and success. Key stakeholders in the health system

need to be engaged for the CCM to be properly implemented and sustained.2,171

2.5.2.2 Decision Support

Decision support uses specialist expertise to establish evidence-based clinical practice

guidelines, standards, and protocols. Use of these evidence based tools can be facilitated

through provider education and support programs. Effective chronic disease programs ensure

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that providers have access to expertise facilitated through evidence-based guidelines.171

Although providers need to rely on expertise such as guidelines, they are often reluctant to do

so. Studies done within the University of Pittsburgh Medical Center UPMC demonstrated that

physicians were not delivering care based on evidence-based guidelines. Because more than

90% of visits are to primary care practices, it is crucial that they adopt a process delivery system

that included use of evidence-based guidelines. This can be done through continuing medical

education, clinical meetings in resource poor countries like Nigeria. Practices can have an

evidence based protocol for chronic illnesses. Studies show that engaging in decision support

improves clinical outcomes.171

2.5.2.3 Self-Management Support

This element engages the patient in the active self-management of his or her illness. When

informed patients take an active role in managing their disease and providers are prepared,

proactive, and supported with time and resources, their interaction is likely to be productive.172

The goal is to customize care to engage the patient in setting goals that change their behavior

to self-manage their diabetes. Systems that support the development of informed, activated

patients have demonstrated positive outcomes.173,174 The CCM differs from traditional

approaches in that it emphasizes self-management training and counseling. Increasing patient

participation is a crucial element in successful chronic disease management.171

DSME is critical in laying the foundation for promoting the knowledge and skills necessary for

patients with diabetes to appropriately perform and manage self-care tasks. DSME is now

widely considered to be an important part of diabetes management.172

Although the provider office provides a unique opportunity to reach patients at point of service,

DSME programs have traditionally been delivered in hospitals, not office settings. This is a

remnant of the acute care model, in which services were provided at the hospital, and referral

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to a program within the hospital was expected. Within the structure of the CCM, which is now

recognized as best representing the care needs of people with diabetes, exploring new methods

for care delivery is recommended.171 Culturally appropriate DSME within the limits of the

available resources can be offered to individuals even in resource limited countries.175 Both the

AADE and ADA have concluded that adoption of a systems approach specific to DSME is

critically important and much needed.176

2.5.2.4 Community Resources and Policies

Communities provide individuals with diabetes, their caregivers, friends, and employers with

a variety of ancillary services that provide support for diabetes self-management. Policies

define relationships within a community between various agencies (e.g, networks, how services

are accessed and provided, etc). Policies are also important for reimbursement and

sustainability. Identifying or developing resources to support healthy lifestyles can be achieved

through community based diabetic associations. This can be done by implementing surveys,

town hall meetings, and focus groups. Working with community partners in churches, wellness

sites and schools is helpful. Partnership with insurers, government agencies, policy makers is

esssential.2`

2.5.2.5 Clinical Information System

These systems are necessary for collecting and housing timely, useful data about individual

patients and populations of patients, using tools such as patient registries and care reminders.

The information system allows quality measures to be assessed and care evaluated, providing

ongoing feedback to the provider and patient.2

2.5.2.6 Delivery System Design

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Effective chronic illness management also requires attention to delivery system design.171

Moving from a reactive to a proactive care delivery system, where planned visits are

coordinated through a team-based approach. And appropriate referral ensured. This element

defines team roles and delegates tasks. Planned management ensures continuity of care and

regular follow-up through redesigning how care is delivered. New partners and approaches for

DSME support such as community workers, office staff, and telephonic and computer systems

should be engaged.172 Team-based care has repeatedly been shown to improve outcomes, yet

it is often unavailable in primary care practice settings.171

2.5.3 Effect on Self-Management Behaviour and Glycaemic Control

Studies have also shown that clinicians in small independent Primary Care practices are able

to incorporate elements of the CCM into their practice style, often without major structural

change in the practice. This incorporation is associated with higher levels of recommended

processes and better intermediate outcomes of diabetes care. Clinician-reported use of elements

of CCM was significantly associated with lower HbA(1c) values with 0.30% reduction in

HbA1c value.12 These findings are however limited by their self- reported nature which may

lack precision. Though the data assessed the patterns of care in practices where no previous

systematic efforts to implement CCM has been attempted so a cause to hope that small efforts

might lead to improvement. Simenero and colleagues showed that implementation of the CCM

in a primary care setting is associated with improvement in glycaemic control with sixty

percent of patients having A1C results < 7%,177

An integral facet of the CCM is the importance of self-management support. A growing body

of evidence demonstrates that interventions that foster patient self-management behaviors

improve health status and lower health care costs in chronic disease.172 A systematic review of

71 trials by Warsi and colleagues also showed reductions in A1C in patients who received

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formal training in diabetes self-management (summary effect size, 0.45; 95% confidence

interval [CI], 0.17-0.74) .178 Although a limitation of the review is that methods used in

reporting the trials were heterogeneous, it showed that self management education has benefits

in diabetes.

Positive outcomes are linked to DSME/T that focuses on self-management, emphasizes

behavioral strategies, and provides culturally relevant information. Models that encourage

active engagement of patients and build self efficacy have been shown to increase the

effectiveness of self-management skills and improve outcomes.179 A review and meta-analysis

of self-management interventions for diabetes concluded that, although education alone does

not lead to improved outcomes, self-management interventions can improve glycaemic control.

It improved glycated hemoglobin levels at immediate follow up, and that increased contact

time is associated with an increased effect. Self-management education was shown to decrease

HbA1c levels in the intervention group at immediate follow-up by 0.76% more than the control

group. 179 The studies included in this review use a variety of measurement techniques for

HBA1c and most of the studies included in this review predate standardization efforts.179

However, there is evidence of the benefits of these interventions in improving glycaemic

control.179

A randomized controlled trial by Piatt and colleagues showed that DSME/T, when

implemented within the context of the Chronic Care Model, improved clinical and behavioral

outcomes in an underserved community. And a marked decline in HbA1c of 0.6% was

observed in the CCM group.180 An advantage of this study is that analysis of HbA1c was done

using a standardized method.

Vallis and colleagues examining the long term effect of diabetes self-management education

showed significant improvements in adherence to most aspects of self-care, including

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medication use, self testing, exercise, foot care and general health behaviours like nutrition,

exercise, and weight. Identification of goals and achieving them increased substantially as a

result of these strategies. Importantly, all of these changes, with the exception of medication

adherence, were sustained at the 2-year follow-up.181 These data validate the importance of

self-management education beyond its effect on glycaemic status. Another study showed

significant improvement in clinical indicators of diabetes management, higher rates of self-

management goal setting and achievement, and increased satisfaction with diabetes care. Also

a reduction of 0.8 percentage point was observed in A1C levels.182 Interpretation and

generalizability of these data are limited by the lack of a true control group.182 Self-care

behaviours (e.g. self-testing, healthy eating, physical activity) are important outcomes, since

they are directly targeted for change during self-management education. However, the

assessment of self-care outcomes has been limited by a lack of reliable and valid measures.

Brown and colleagues demonstrated that culturally competent self-management education, in

both individual and support group settings, improved health outcomes in Mexican-Americans,

particularly those with an A1C level under 10%.183

Studies done among Family Medicine Residents in the United States where the chronic care

model was implemented among diabetic patients showed an overall improvement in measures

of care for patients, with the percentage achieving HbA1c, LDL, and BP goals simultaneously

increasing from 5.7% to 17.1%.14 Also, educational outcomes for the residents, measured by

compliance with review of provider performance reports and self-management goal-setting

with patients, also significantly improved.14 However, there was no control group in this study

so it cannot be ascertained that the clinical changes observed were due to the intervention.

Implementing systems to support decision support, self-management education, and delivery

system redesign has been shown to have a positive influence on practices and patient outcomes

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in outlying rural communities.184 And studies have shown that delivery system design is

associated with improved A1C and LDL outcomes for people with diabetes.185

2.5.4 Challenges

Despite the rise in incidence, diabetes care remains less than optimal when judged by the

percentage of patients receiving recommended care or achieving certain results. For example,

although widely disseminated evidence-based recommendations support achieving a

haemoglobin A1c (HbA1c) level of less than 7%, only 42% of diabetics in the US achieved

this goal in a national population-based survey.186 Academic practices face additional

challenges, including faculty physicians with part-time practices, lack of care coordination

across an open-model health system, care teams that include medical students and residents

with widely varying clinical experience in ambulatory settings, and a higher prevalence of

underinsured patients with fewer resources for care optimization.167.

Various trials provide substantial evidence that application of elements of the CCM will

improve care for individuals with diabetes.167 But despite the CCM’s success for several

chronic illnesses, implementation in Primary Care practices has been minimal. And little is

known about the effectiveness of such models in an academic setting with a diverse patient

population and resident physicians participating in clinical care.167

The lack of physician training in chronic illness management is an obstacle.14 This might be

due to the fact that there is no laid down CCM protocol in most health care settings, though the

fact that aspects of CCM are difficult to implement due to the low economic status of most

patients and lack of electronic medical records in most primary care settings might be a

contributing factor. These factors also contribute to the difficulty in implementation of CCM

in Primary Care settings in Nigeria. Also, implementing and maintaining CCM requires on-

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going advocacy as it requires educational and financial support, and a leadership committed to

change.2

The criticism that follow-up of chronically ill patients tends to be sporadic, prevention

underutilised, and the patient's role in disease management overlooked in many health

systems166 is generally applicable to Nigerian primary care. Inadequate health infrastructure,

poverty, low literacy level and poor health seeking habits are also contributing factors. A

number of other studies have reported findings that strongly support cost reduction as a benefit

of diabetes education. Adisa and colleagues in Southwestern Nigeria showed that high cost of

medication (35.5%) was one of the major non-intentional reasons for nonadherence.187 Another

study done in UCH Ibadan also showed that high cost of the drugs and the large number of

drugs to be taken (43.5%) were the commonest reasons that militate against adherence. It also

showed that most patients were mainly from the low socio-economic class.104 The care of

diabetes is expensive compared to management of other chronic illnesses. Most patients with

diabetes in Nigeria have little or no formal education and are poor with little understanding of

the nature of their disease.104 Self- management behaviours with emphasis on self- monitoring

of blood glucose was poor. Many patients did not understand the importance of lifestyle

modification.104 This probably implied that many patients would not adhere to dietary and

lifestyle modifications recommended by their health care providers. The use of patient self -

report measures in assessing adherence to lifestyle modification in these studies..

Additionally, scarcity of health resources, prohibitive cost of drugs or their non-availability,

sale of fake drugs and the easy access to the traditional and faith healers militate against the

optimal management of a chronic disease like diabetes mellitus.104 Efforts are needed to

increase the medication adherence and self –management practices of these patients in Nigeria

so they can realize the full benefits of prescribed therapies relevance of these non-drug

therapies in the management of type 2 diabetes.187

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Implementing elements of CCM in diabetic care will improve health outcomes for patients in

a cost effective manner as it will help patients maintain effective self-management behaviour

throughout a lifetime of diabetes. This can be implemented in resource limited countries like

Nigeria to all categories of patients irrespective of gender, educational status or social class.

Hence the need to experimentally test whether application of CCM based practices would

improve the process of care and evaluate its impact on the self- management behaviour and

glycaemic control of patients in our setting and thus pinpoint areas where changes can be made

to improve diabetic care.

2.6. PATIENT ASSESSMENT OF CHRONIC ILLNESS CARE (PACIC)

Implementation of the CCM from the patient perspective can be assessed using the Patient

Assessment of Chronic Illness Care (PACIC) survey. It focuses on the receipt of patient-

centred care and self-management behaviours. It is a 20-item validated patient report

instrument that assesses patient’s receipt of clinical services and actions consistent with the

CCM.15

Assessment of system-level CCM implementation has primarily focused on the perspective of

the clinician and the health plan, using tools such as the Assessment of Chronic Illness Care

(ACIC).188

The PACIC collects patient reports of the extent to which they have received specific actions

and care during the past 6 months that are congruent with various aspects of the CCM.15

It is designed to complement the ACIC by providing a patient perspective on receipt of CCM

related chronic illness care. The PACIC consists of 5 scales which represent; patient activation,

delivery system, goal setting, problem solving/ contextual counselling , and follow-

up/coordination and an overall summary score, each having good internal consistency for brief

scales. The PACIC demonstrated moderate test-retest reliability (r _ 0.58 during the course of

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3 months) and The PACIC and its scales demonstrated substantial construct validity by

correlating moderately, as predicted (r _ 0.32– 0.60, median _ 0.50, P _ 0.001) to measures of

primary care and patient activation.

It has potential for use as a patient-centred measure of the implementation of the Chronic Care

Model (CCM). Using a patient-level assessment of health care such as the PACIC is consistent

with calls for both practical tools for evaluating chronic care management 189,190 and for quality

measurement tools that are patient-centred and focus on patient perspectives.15 It can

potentially be used to track delivery of self-management support for patients by health care

organizations and to support overall quality improvement efforts.190-1 This is useful in

evaluating the strengths and weaknesses in health care systems even in resource poor settings

like Nigeria, though it was not developed to be an actual representation of evidence but a tool

that could be used to encourage physicians to identify problems and discover solutions to the

problems.

CHAPTER THREE

3.0 METHODOLOGY

3.1 Study design:

The study was a single blinded randomized controlled trial, comprising an intervention group

that received care by the Chronic Care Model and a control group that received usual care/

traditional model of care.

3.2 Study setting

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The study was conducted in the GOPD of JUTH. The hospital is located in Jos, the capital city

of Plateau State, North Central Nigeria. It is located at latitude 9º55´N and longitude 8º 53´ E

with an altitude of about 1250m (about 4100 ft) above sea level. It covers an area of about

7,800 sq km. Temperatures on the Plateau are generally about 4ºC cooler than those on the

coast, and the annual rainfall of about 1,300 mm is considerably higher than that in the

surrounding lowlands.192 Jos is a cosmopolitan city where various tribes of the country are

represented. According to the 2006 national census, the state had a population of 3,178,712

and Jos had a population of 900,000.193

The Jos University Teaching Hospital provides primary, secondary and tertiary care to the

population of Plateau and the neighbouring states of Nassarawa, Benue, Kaduna, Bauchi,

Gombe, Adamawa, Taraba, Federal capital territory and Kogi. The GOPD provides continuous,

holistic and comprehensive healthcare for both acute and chronic medical conditions while

referring outpatients to specialist departments or clinics in a two way referral system as

necessary. In 2010, the average population of patients attending the GOPD was 17,659 and

diabetic patients accounted for 3% of this population.170

3.3 Study population

The study population comprised type 2 diabetes patients who had been diagnosed for at least

one year; confirmed with a FBG of ≥ 7mmol/L (126 mg/dL) at diagnosis, aged 18 years and

above presenting in the General Outpatient Department of the Jos University Teaching

Hospital.

3.4 Study Hypothesis

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The study postulates that there will be a difference in the mean glycated haemoglobin and self-

management behaviour in type 2 diabetes patients who receive care by the Chronic Care Model

compared to those who receive usual care.

3.5 Sample size determination

Using a Power of 80% and a 95% confidence level, the sample size for the study was calculated

using the formula for the difference between the means of two groups194

N = (Zα +Zβ)2 × 2 × (S)2

d2

Where: N = minimum sample size required for each group.

zα = 1.96 which is the t-value of the desired confidence level of 95% when alpha is 0.05

(Statistical standard values in a normal population distribution).194

zβ = 0.842 which is the t-value of the desired power of 80% when β is 0.2 (Statistical standard

values in a normal population distribution).194

S= the degree of variability of observation (SD) = 1.5180 (based on previous study)

d= difference to be detected in the HbA1c scores between the two groups (control and

intervention) which was = 1%

Therefore given:

zα = 1.96 zβ = 0.84 S= 1.5 d = 1.0

N= (1.96+0.84)2×2×(1.5)2 = 33

(1.0)2

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N=35

To account for follow-up losses and ensure adequate numbers for subgroup analysis, 10% of

the minimum sample size was added to each group as the attrition rate which was 3 per group.

Therefore N= 35+ 3= 38 Subjects per group. The total number of patients recruited was 76 (i.e.

10% attrition).

The sample size in each group will be at least 38 in order to account for subjects lost to attrition

(i.e. 10% attrition).

3.6 Eligibility

3.6.1 Inclusion criteria

1. Patients diagnosed with Type 2 diabetes mellitus for at least one year confirmed by a

FBG of ≥ 7mmol/L at diagnosis ( Fasting is defined as no caloric intake for at least 8

hours), aged 18 years and above attending GOPD, JUTH.

2. Subjects who consent to the study and sign the consent form.

3. Subjects who understand English or Hausa language

3.6.2 Exclusion Criteria

1. Patients ill enough to require hospitalization

2. Pregnant women (because they would require specialized care)

3. Patients who are unlikely to be available for the whole duration of the study

3.7 Recruitment, allocation and randomization

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Using systematic random sampling technique, all type 2 diabetic patients who met the inclusion

criteria were recruited voluntarily into the study after written informed consent was obtained.

(All phone numbers and baseline fasting blood glucose before commencement of the study

were recorded). An average of 150 diabetic patients are seen per month in the GOPD (study

population). Sample size calculated was 76. Sampling interval was thus; 150/76= 2 patients.

(Number of population/number of sample size).

Recruiting patients as they present, the first patient was selected from the first two patients by

balloting and was thus number 1, (counting the next 2 patients that met the inclusion criteria);

the 3rd patient was the 2nd subject. Subsequent patients were recruited following this sequence

(i.e. sampling intervals of 2) until a total of 76 patients were recruited. This took four weeks.

All the 76 type 2 diabetic patients who were recruited using the systematic random sampling

technique were given an inclusion number and then randomized. Using a computer–generated

sequence table, patients were randomly allocated to two groups; A and B in block sizes of four.

Subjects in group A were allocated to the control group i.e. those who received the traditional

model of care/usual care (n=38) and those in group B were allocated to the intervention group

i.e. those who received care by the chronic care model (n = 38). They were assigned to either

of the groups by means of previously sealed opaque numbered envelopes, which were only

opened at the time of treatment allocation. So the subjects did not know which study group

they belonged to.

3.8 Instruments of data collection

1. Study questionnaire (Appendix B)

2. PACIC scale (Appendix C).

3. Chronic Care Model instruction sheet (Appendix D).

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4. Digital bathroom weighing scale (Camry)

5. Wall-mounted Standiometer.

6. Sphygmomanometer ( ACCOSON)

7. Littman’s stethoscope

3.9 Assessment tool

The Patient Assessment of Chronic Illness Care (PACIC) scale (Appendix D): Is a 20 item

validated scale divided into 5 sub-scales:

Patient activation – 1-3

Delivery system - 4-6

Goal setting – 7-11

Problem solving/ contextual counselling – 12-15

Follow-up/coordination – 16-20

This scale was used to assess the receipt of patient-centered care, which emphasizes the key

elements of modern self-management. It gathers data on receipt of quality chronic condition

care from the patient’s perspective and collates data on the extent to which specific actions

have been received in the previous six months.

Respondents answered each item with a response from 1 = almost never to 5 = almost always.

Each scale was scored by simple averaging of items completed within that scale, and the overall

PACIC was scored by averaging scores across all 20 items. Thus, scores on the PACIC ranged

from 1 to 5 with higher scores indicating patient’s perception of greater involvement in self-

management and receipt of chronic care counselling. When fewer than 20 questions were

86

answered, the PACIC score represented the mean score of all completed questions.15 The mean

score was computed for each study group both pre and post intervention. Scores < the median

score were classified as poor and ≥ median score as good. The questionnaire was interviewer-

administered and this was done in English or Hausa language where necessary. Translation of

the questionnaires was done by a doctor who was a native speaker then back translated by a

non-medical person to ensure content validity and standardization.

3.10 Data collection

A pilot test of the instruments was performed among twelve diabetic patients in May 2012,

four weeks before the commencement of the study. It was done at the GOPD. Those twelve

subjects were excluded from the study. The pretesting of the questionnaires was done to test

duration, ease and feasibility of administration. The pre-test also assessed how well the subjects

understood the questions and helped in clarification of any ambiguity. It revealed that self -

administration of the questionnaire might be inappropriate considering the varying levels of

education of the subjects. The instruments were therefore administered to the respondents by

the research assistant who was trained in administering the tools. The questionnaire was

administered in English language or Hausa language. Translation of the questionnaires was

done by a doctor who was a native speaker then back translated by a non-medical person to

ensure standardization. After recruiting and allocation was done, each subject was interviewed

by the researcher using a structured questionnaire (Appendix B). Items recorded on the

questionnaire were the subject’s socio-demographic details (including age, sex, tribe, religion,

education level, occupation and marital status, phone numbers of the patient, contact address),

medical history (including family history of diabetes, history of diabetic complications,

comorbid conditions, knowledge of diabetes and lifestyle practices) and family and social

history. The PACIC score of each subject were also assessed at initial and final visits by the

research assistant. Each subject also had a focused physical examination. The physical

87

examination included the height, weight, blood pressure, and body mass index (BMI). The

weight was to the nearest 0.1kg, height to the nearest 0.01m from which body mass index was

calculated. Height was measured in centimetres (cm) using a wall-mounted standiometer. The

subjects were without shoes and head gear and they stood erect with their hands at their sides.

The head, buttocks and feet against a vertical wall, with the head level with the horizontal

plane. Weight was measured in kilogrammes (kg) to the nearest 100 g without shoes and with

minimal clothing using a digital bathroom scale that was calibrated with a known weight daily.

Body mass index (BMI) was calculated as weight (in kg) divided by height (in metres) squared

(kg/m2). The waist circumference was measured by placing a measuring tape in a horizontal

plane around the abdomen at the level of the iliac crest with the subject standing. Measurement

was done at the end of a normal expiration. The hip circumference was measured at the level

of the greater trochanters. The waist–hip ratio (WHR) was calculated by dividing the waist

measurement in centimetres by the hip measurement in centimetres.

Subjects’ blood pressure was measured three times in the sitting position on the left arm using

a mercury sphygmomanometer after at least 5 minutes of rest, with at least 5 minutes between

measurements. First appearance and disappearance (phase V) of Korotkoff’s sounds heard with

the aid of a Littman’s stethoscope were used to define systolic and diastolic pressures

respectively. Blood pressure readings were recorded to the nearest even number and the mean

of the three recordings computed. All these measurements were done by the researcher at each

visit to avoid inter-observer error. A standard mercury sphygmomanometer (Accoson) was

used for blood pressure measurement. They were instructed to avoid cigarette smoking,

ingestion of kolanut and coffee prior to measurement of the blood pressure. The above

mentioned physical examinations were repeated for each subject at each visit.

Foot inspection was done and any abnormalities like calluses, conns, fungal infections and

ulcers noted and treated appropriately. Palpation of the dorsalis pedis and posterior tibial pulses

88

was done to identify any compromise. Vibration sense using a tuning fork of 126Hz and

sensation were assessed. All these were done at initial and final visits. The glycated

haemoglobin was also assessed at initial and final visits. The glycated haemoglobin was

assayed using the DCA analyzer. It is a quantitative assay based on a latex

immunoagglutination inhibition methodology. It is certified by the National Glyco-

haemoglobin Standardization Program (NGSP) and standardized against the Diabetes Control

and Complications Trial (DCCT) reference method. Hence it is a DCCT approved method as

recommended.11

Control Group

In the control arm, patients received the usual care provided to all diabetic patients attending

the GOPD. They were asked if there were problems and adherence to treatment plan reviewed.

FBG and past prescriptions were reviewed and adjustments made where necessary

They were given verbal advice on lifestyle modification (drugs, exercise, diet) and advised on

any other problem. They were asked to return for follow up at four weeks, eight weeks and 12

weeks.

Intervention Group

All patients in the intervention group received care based on some elements of the CCM using

a structured format (Appendix C).

It involved counselling on elements of DSME involving key self-care behaviours that include;

eating healthy, being active, monitoring( glucose monitoring and foot care), taking medication,

problem solving(identifying and responding to diabetic emergencies), healthy coping (setting

a self- management goal), and reducing risk.

89

It also involved appropriate referral so they were all given referral letters to the

Ophthalmologist and dietician; and subjects with diabetic foot referred for surgical review.

Feedback was requested and progress of their care with the Specialists was monitored. Their

visits were planned and coordinated by the researcher. The control group was seen on Mondays

and Wednesdays while the intervention group was seen on Tuesdays and Fridays. The head of

record in the GOPD was informed about the study and a record officer was engaged to help

during the duration of the study. This ensured that cards were retrieved promptly and made

available to the researcher on the appointment days. Proper documentation of results of each

subject was ensured and made easily available on each appointment day. The patients were

updated on their clinical progress and their self-management goals for each month discussed.

They were encouraged to discuss their challenges, counselled on self-help skills and

collaboratively a management plan made for each month.

Integration of community resources in the management was encouraged by advocacy to join

the Jos branch of the Diabetic Association of Nigeria which meets every first Saturday of the

month in the GOPD, JUTH.

They were given written instructions on aspects of the CCM management in either English or

Hausa language (which is a common language spoken in the environment) for easy

comprehension for the subjects who read and write in Hausa language. The Hausa instruction

sheet was translated into Hausa by a Doctor who was a native speaker and back translated by

a non-medical person in order to ensure content validity and a standardized instruction sheet.

They were asked to keep a diary of the recommended activities they did each day. Subjects that

were not literate were taught how to use a tally system. Responses to participants’ level of

engagement in key self-management behaviours: following an eating plan; eating fruits and

vegetables; engaging in physical activity (30 minutes of aerobic exercises); and taking

medications were recorded. Behaviour change was assessed from the percent of patient visits

90

in which a specific behaviour was reported for either <four days per week or four days or more

per week.175 They were asked to return for follow up at four weeks, eight weeks and 12 weeks.

At each follow-up visit, the instructions were repeated according to the structured format in

order to ensure comprehension. The obstacles that prevented the patient from adhering to the

instruction sheet were noted and ways to overcome them discussed.

The subjects in the two groups were seen on different follow-up dates to avoid contamination

and there was no crossing over of subjects during the entire study.

3.11 Duration of study:

The pilot test was done in May 2012. Eighteen patients were recruited per week and recruitment

of 76 patients took four weeks. Follow up was done over three months, making a total of four

months for data collection. Data collection took place between June and September 2012. An

additional four weeks was used to analyze and write up the data.

3.12 Data analysis:

The data was analysed using the Statistical Sciences for Social (SPSS) software (Version 18;

SPSS, Chicago , USA). 194-5 Descriptive analysis was done to compare both groups. Primary

outcome variables of interest were HbA1c and PACIC score. The t-test was used to compare

the continuous outcome variables of both study arms while proportions of categorical variables

between the groups were compared using the χ2 test and the Fisher’s exact. The Fisher’s exact

test was used to test for statistically significant associations when a cell contained five or less

observed variables. Continuous variables were expressed as mean and standard deviation while

categorical variables as number and percentages. Data of all the subjects who completed the

study was analyzed. P-values of <0.05 were considered significant. The results were presented

in the form of tables, bar and pie charts.

91

3.13 Ethical considerations

Approval for the study was obtained from the ethical committee of the Jos University Teaching

Hospital. The nature, aim and objectives of the study were explained to the patients.

Participation in the study was voluntary and informed consent was obtained from all

participants. The study was at no cost to the patients with all laboratory investigations paid for

by the investigator. The study involved no extra cost to the patient or extra clinic attendance.

The information obtained from the study was treated as confidential. The subjects had the

option of opting out of the study at any point with no prejudice to their further treatment.

CHAPTER FOUR

4.0 Results

4.1 Subjects flow through the study

Seventy-six (76) subjects fulfilled the inclusion criteria and participated in the study. This

number was randomised into the intervention and the control groups. However, only seventy

(92.1%) subjects completed the study. This included thirty-four in the control group and thirty-

six in the intervention group. The attrition rate was therefore 7.9%. Among the six (7.9%)

subjects that did not complete the study, four were in the control group and two were in the

intervention group. Out of the six subjects that did not complete the study, two relocated out

of Jos due to the sectarian crisis, one voluntarily withdrew from the study, while three subjects

were lost to follow-up despite all attempts at calling them. One of them opted for traditional

medication for treatment of his diabetic foot and didn’t come back after the first visit. He didn’t

come back to Jos throughout the duration of the study.

Analysis was carried out on the data of the seventy subjects that completed study.

92

Figure 4.1: STUDY TRIAL PROFILE

Pre-intervention administration of

PACIC questionnaire

Recruited and

Randomised

N=76

Intervention

N=38

Control

N= 38

Patient comes into

GOPD and card is

retrieved by the

Record Officer

93

Post-intervention administration of

PACIC questionnaire

4.2 Baseline characteristics of the intervention and control groups

The mean age of the subjects in the study was 55.65 ± 10.74 years. The ages ranged from 36-

85 years. There was no significant difference between the mean ages of the control

(54.47±10.05) and the intervention groups (56.82 ± 11.42 years); (t= 0.949, p= 0.346). In the

study, there were more females (71.05%) than males (28.95%). There was however no

significant difference in the sex distribution of the subjects across the two groups (χ2= 1.024,

p= 0.312). There were no significant differences in terms of the baseline demographic

characteristics between the two groups which shows the two groups are comparable and

randomisation was effective. Details of the baseline characteristics are summarized in table 4.1

Table 4.1: Baseline characteristics of subjects

(*=Fisher’s exact test)

Control group

N=38

N(%)

Intervention group

N=38

N(%) t-test

p

value

Mean Age (years) 54.47±10.05 56.82±11.42 0.949 0.346

Lost to

Follow-up

N= 2

Analysed

N= 36

Analysed

N= 34

Lost to

Follow-up

N= 4

94

Age category(years)

30-39 2 (5.3) 2 (5.3) 0.73*

40-49 9 (23.7) 6 (15.8)

50-59 15 (39.5) 16 (42.1)

60-69 8 (21.1) 7 (18.4)

70-79 4 (10.5) 5 (13.2)

80-89 0 (0) 2 (5.3)

Gender: χ2

Male 9 (23.7) 13 (34.2) 1.02 0.31

Female 29 (76.3) 25 (65.8)

Religion:

Christian 20 (52.6) 22 (57.9) 0.21 0.64

Islam 18 (47.7) 16 (42.1)

Control group

N=38

N(%)

Intervention group

N=38 χ2

N(%)

p

value

Tribe:

Berom 9 (23.7) 9 (23.7) - 0.34*

Hausa 17 (47.7) 10 (26.3)

Igbo 2 (5.3) 1 (2.6)

Yoruba 2 (5.3) 5 (13.2)

Others 8 (21.1) 13 (34.2)

Educational Level:

95

None 23 (60.5) 18 (47.4) - 0.41*

Primary 6 (15.8) 12 (31.6)

Secondary 2 (5.3) 3 (7.9)

Tertiary 7 (18.4) 5 (13.2)

Occupation:

Unemployed 11 (28.5) 10 (26.3) - 0.40

Trading 13 (34.2) 10 (26.3)

Civil servant 4 (10.5) 1 (2.6)

Artisans 3 (7.9) 4 (10.5)

Others 7 (18.4) 13 (34.2)

Average family income

(naira):

<20,000

27 (71.1) 27 (71.1) - 1.00*

20,000 – 40,000 6 (15.8) 7 (18.4)

40,001 – 60,000 3 (7.9) 12 (5.3)

>60,000 2 (5.3) 2 (5.3)

Alcohol consumption:

Yes 2 (5.3) 5 (13.2) - 0.22*

No 36 (94.7) 33 (86.8)

Cigarette smoking:

Yes 0 (0.00) 1 (2.6) - 0.50*

No 38 (100.0) 37 (97.4)

96

4.3 Baseline Medical history of the intervention and control groups

The mean year of diagnosis was 5.1± 4.4. Majority (51) of the study subjects (67.1%), had

been diabetic for 1-5 years, with 24 of them in the control group and 27 in the intervention

group. There was no significant difference across the two study groups in the duration of years

the subjects had been diabetic (p-value= 0.78). There was a family history of diabetes in 31

(40.8%) of the subjects, 11 (14.5%) of the subjects had a past history of hyperglycaemic crises,

three (3.9%) had a history of hypoglycaemic crises and only one (2.6%) had a history of stroke.

There were 60 (79%) of subjects with hypertension; 30 in each group. The number of subjects

who knew the appropriate blood glucose target were six (15.8%); one in the control group and

five in the intervention group (p=0.10), and 12 (31.6%) of the subjects practiced self-foot

examination; three in the control group and nine in the intervention group. None of them

however did it daily. There was no significant difference across the two groups (p=0.06).

Details of the medical history of the study subjects are summarized in table 4.2.

Table 4.2: Baseline Medical history of subjects

Control group

N=38

N(%)

Intervention group

N=38 t-test

N(%)

p

value

Mean year of diagnosis

(years)

5.02±4.41 5.18±4.40 0.16 0.88

Year of diagnosis(years) χ2

1-5 24 (63.2) 27 (71.1) 0.78*

6-10 10 (26.3) 7 (18.4)

11-15 4 (10.5) 4 (10.5)

Family history of DM:

97

Yes 14 (36.8) 17 (44.7) 0.49 0.48

No 24(63.2) 21 (55.3)

Control group

N=38

N(%)

Intervention group

N=38 χ2

N(%)

p

value

Past medical

emergency:

None 30 (78.9) 31 (81.6) - 1.00*

Hyperglycaemic

crisis

5 (13.2) 6 (15.8)

Hypoglycaemic

Crisis

2 (5.3) 1 (2.6)

Stroke 1 (2.6) 0 (0)

Frequency of admission

In the past 12 weeks :

None 34 (89.5) 33 (86.8) - 1.00*

Once 3 (7.9) 3 (7.9)

≥Twice 1 (2.6) 2 (5.2)

Associated morbidity:

Hypertension 30 (79.0) 30 (79.0) - 0.51*

Stroke 1 (2.6) 0 (0.00 )

None 7 (18.4) 8 (21.0)

98

Type of medications

Presently on::

Insulin 2 (5.3) 2 (5.3) - 0.50*

OGLA 36 (94.7) 36 (94.7)

Knowledge of appropriate

blood glucose level:

Yes 1 (2.6) 5 (13.2) - 0.10*

No 37 (97.4) 33 (86.8)

Practice self-foot

Examination:

Yes 3 (7.9) 9 (23.7) 3.56 0.06

No 35 (92.1) 29 (86.3)

*=Fisher’s exact test

4.4 Baseline clinical characteristics of the intervention and control groups

The mean BMI was 30.17±5.25 versus 29.24±4.52 in control and intervention groups

respectively. The proportions of normal, overweight and obese in both groups were similar (p

= 0.09). Foot examination was normal in sixty (79%) of the subjects. The remaining had

abnormal findings out of which two (2.6%) of the subjects had leg ulcers. There was no

significant difference across the two groups (p-value=0.26). Eight (21%) of the subjects had a

derangement in vibration sense. The peripheral pulses and fine sensation were however intact

in all subjects.

The mean SBP was 133.4± 17.13mmHg in control versus 132.2±15.6mmHg in the

intervention group. The mean DBP was 84.74± 11.09mmHg in the control versus 84.73±

99

13.1mmHg in the intervention group. Details of the baseline clinical characteristics of both

groups are presented in table 4.3.

Table 4.3: Baseline clinical characteristics of subjects

Control group

N=38

N(%)

Intervention group

N=38 t-test

N(%)

p

value

Mean Weight (kg) 78.55±17.39 77.55±12.80 0.286 0.876

Mean Height (m) 1.61 ± 0.08 1.63 ± 0.07 0.873 0.390

Mean BMI (kg/m2) 30.17 ± 5.25 29.24 ± 4.52 0.826 0.412

BMI class (kg/m2) χ2

Underweight 1 (2.6) 0 (0.00)

Normal 5 (13.2) 6 (15.8)

Overweight 10 (26.3) 18 (47.4)

Class I Obesity 14 (36.8) 11 (44.0)

Class II Obesity 7 (18.4) 1 (2.6) 0.094*

Class III Obesity 1 (2.6) 2 (5.3)

Control group

N=38

N(%)

Intervention group

N=38 t-test

N(%)

p

value

100

Mean WC (cm) 99.71 ±13.83 99.00±10.96 0.25 0.81

Mean HC(cm) 107.37 ± 12.33 106.16 ± 10.0 0.47 0.64

Mean Waist :Hip ratio 0.93 ± 0.05 0.93 ± 0.07 0.42 0.68

Mean systolic BP (mmHg) 133.4 ± 17.13 132.2 ± 15.6 0.35 0.73

Mean diastolic BP(mmHg) 84.74 ± 11.09 84.73 ± 13.1 0.004 0.99

Control group

N=38

N(%)

Intervention group

N=38 χ2

N(%)

p

value

Foot inspection:

Normal 32 (84.2) 28 (73.7) 1.27 0.26

Abnormal 6 (15.8) 10 (26.3)

Vibratory sensation

Intact 34 (89.5) 34 (89.5) 0.64*

Not intact 4 (10.5) 4 (10.5)

Fine sensation:

Intact 38 (100.0) 38 (100.0)

101

Not intact 0 (0.00) 0 (0.00)

Peripheral pulses:

Intact 38 (100.0) 38 (100.0)

Not intact 0 (0.00) 0 (0.00)

Control group

N=38

N(%)

Intervention group

N=38 t-test

N(%)

p

value

Mean FBG (mmol/l) 9.82 ± 3.78 10.43 ± 5.18 0.43 0.67


4.5 Post-intervention clinical characteristics of the intervention and control groups

There was no significant difference in the mean change in BMI of the control and intervention

groups after twelve weeks of follow up; 29.87±5.46 in the control versus 28.58±3.91in

intervention group (p=0.41).

There was no significant difference in the mean change in SBP and DBP between the control

and intervention groups There was also no difference in foot examination findings and other

clinical characteristics between the control and intervention groups. Details of the post-

intervention clinical characteristics of both groups are presented in table 4.4.

Table 4.4: Post-intervention clinical characteristics of subjects


Control group

N=34

N(%)

Intervention group

N=36

N(%) t-test

p

value

102

Mean Weight (kg) 77.62 ± 17.48 75.6±11.63 0.958 0.341

Mean Height (m) 1.61 ± 0.08 1.63 ± 0.07 0.873 0.390

Mean BMI (kg/m2) 29.87± 5.46 28.58 ± 3.91 1.127 0.264

BMI class (kg/m2) χ2

Underweight 1 (2.9) 0 (0.00)

Normal 5 (14.7) 5 (13.9)

Overweight 9 (26.5) 20 (55.6)

Class I Obesity 11 (32.4) 9 (25.0)

Class II Obesity 7 (20.6) 2 (5.6) 0.07*

Class III Obesity 1 (2.9) 0 (0.00)

Mean WC (cm) 97.91 ± 14.67 97.28±9.87 0.21 0.83

Mean HC(cm) 106.85 ± 13.06 105.3±9.68 0.54 0.59

Mean Waist :Hip ratio 0.91 ± 0.05 0.92±0.07 0.63 0.53

Control group

N=34

N(%)

Intervention group

N=36 t-test

N(%)

p

value

Mean systolic BP (mmHg) 130.29 ± 19.62 128.06±16.4 0.52 0.61

Mean diastolic BP(mmHg) 83.82 ± 9.85 83.80±10.18 0.008 0.99

χ2

103

Foot inspection:

Normal 30 (88.2) 29 (80.6) 0.78 0.38*

Abnormal 4 (11.8) 7 (19.4)

Vibratory sensation

Intact 31 (91.2) 32 (88.9) 0.53*

Not intact 3 (8.8) 4 (11.1)

Fine sensation

Intact 34 (100.0) 36 (100.0)

0 (0.00) 0 (0.00)

Peripheral pulses:

Intact 34 (100.0) 36 (100.0)

Not intact 0 (0.00) 0 (0.00)


4.6 Glycated haemoglobin in the intervention and control groups

4.61 Baseline glycated haemoglobin

The mean HbA1c was 9.17± 2.56 in the control group; compared to 9.16 ± 2.2 in the

intervention group. 55 subjects (72.4%) had a HbA1c ≥ 7%; 27 in the control group and 28 in

the intervention group (p=0.99). This is shown in table 4.5. The remaining 21 (26.3%) had

good glycaemic control (figure 4.2). There was no significant difference in the mean HbA1c (t-

test=0.01, df=76, p=0.99) between the two groups at the commencement of the study, hence

the two study groups were comparable at baseline.

Table 4.5: Baseline glycated haemoglobin of subjects

104

Control group

N=38

N(%)

Intervention group

N=38

N(%) t-test

p

value

Mean HbA1c (%) 9.17 ± 2.56 9.16 ± 2.20 0.01 0.99

HbA1c class (%) χ2

Normal HbA1c 11 (29.0) 10 (26.3) 0.07 0.80

Abnormal HbA1c 27 (71.0) 28 (73.7)

4.62 Post-intervention glycated haemoglobin

At the end of twelve weeks, the mean HbA1c in the intervention group was 8.41 ± 2.4 versus

8.05 ± 1.16 in the control group. There was a higher mean reduction in HbA1c of -1.11% to in

the intervention group compared to -0.76% in the control group. There was however no

significant difference between the two groups (t-test= 0.75, p= 0.46). The number of subjects

with good glycaemic control increased from ten to eleven in the intervention group. But there

was no change in the number of subjects with good glycaemic control in the control group

(χ2=0.03, p=0.87). This is shown in table 4.6.

Table 4.6: Post- intervention glycated haemoglobin of subjects

Control group

N=34

N(%)

Intervention group

N=36

N(%) t-test

p

value

Mean HbA1c (%) 8.41 ± 2.42 8.05 ± 1.16 0.75 0.46

105

HbA1c class (%) χ2

Normal HbA1c 10 (27.8) 11 (30.6) 0.03 0.87

Abnormal HbA1c 24 (72.2) 25 (69.4)

4.7 Self- management behaviour of the intervention and control groups

4.71 Baseline self- management behaviour

At enrollment, majority of the subjects (84.2%) either did not engage in any form of exercise

or exercised irregularly; 31 in the control group versus 33 in the intervention group. Only eight

subjects were engaged in regular aerobic exercise four days or more in a week for the

recommended 30 minutes or more; five (13.1%) were in the control group and three (7.9%) in

the intervention group. The rest of the subjects exercised for less than four days per week. The

commonest exercise undertaken was walking. There was no significant difference between the

two groups (p=0.89).

The eating plan of the subjects based on their dietary pattern in a week was assessed and only

three (7.9%) had a healthy eating plan which involved eating fruits and vegetables, low fat diet

reduction in total food intake and salt intake. The remaining subjects did not engage in any

form of dietary modification. There was no significant difference across the two groups (p-

value=0.12).

The medication taking behaviour was assessed in the subjects based on the number of days

they adhered to medication intake in a week. Majority of subjects (60.5%) took their drugs for

four days and more in a week; 24 in the control group versus 22 in the intervention group. The

remaining adhered only for less than four days in a week (figure 4.6). There was no significant

difference across the two groups (p-value=0.63). Details of the post-intervention self-

management behaviour of both groups are represented in figures 4.2-4.

106

Figure 4.2: Exercise pattern of subjects at baseline

4.3: Eating plan of subjects at baseline

31

2 5

33

2 30

5

10

15

20

25

30

35

irregular or noexercise

< 4 days 4 days or more

Fre

qu

en

cy o

f su

bje

cts

Exercise pattern

control

intervention

35

3

38

00

5

10

15

20

25

30

35

40

zero to < 4 days 4 days or more

Fre

qu

en

cy o

f su

bje

cts

Following a healthy eating plan

control

intervention

107

Figure 4.4: Medication adherence in subjects at baseline

4.72 Post-intervention self- management behaviour

After twelve weeks, the number of subjects that were engaged in regular aerobic exercise for

four days and more in a week for the recommended 30 minutes or more increased from13.1%

to 44.1% in the control group versus 7.9% to 63.9% in the intervention group. The number of

subjects that exercised for less than four days per week were 14.7% in the control group versus

22.2% in the intervention group. The remaining subjects; 41.2% in the control group versus

13.9% in the intervention group did not engage in any form of exercise. There was a statistically

significant difference between the two groups (p=0.03).

The number of subjects that engaged in an eating plan that involved eating fruits and

vegetables, low fat diet reduction in total food intake and salt intake for four days and more in

14

24

16

22

0

5

10

15

20

25

30

zero to < 4days 4 days or more

Fre

qu

en

cy o

f su

bje

cts


control

intervention

108

a week improved from 0 to 94.4% in the intervention group compared to no improvement in

the control group. There was a significant difference across the two groups (p-value<0.001).

The number of subjects that took their medication for four days or more also increased from

24 (63.2%) to 28 (82.4%) in the control group versus 22 (57.9%) to 32 (88.9%) in the

intervention group. There was no significant difference across the two groups (p-value=0.33).

Details of the post-intervention self- management behaviour of both groups are represented in

figures 4.5-7.

Figure 4.5: Post- intervention Exercise pattern of subjects

4.6: Post- intervention eating plan of subjects

14

5

15

58

23

0

5

10

15

20

25

irregular or noexercise

zero to < days 4 days or more

Fre

qu

en

cy o

f su

bje

cts

Exercise pattern

control

intervention

109

Figure 4.7: Post- intervention medication adherence in subjects

4.8 Logistic regression of factors associated with improvement in Glycaemic control:

31

32

34

0

5

10

15

20

25

30

35

40

zero to < 4days 4 days or more

Fre

qu

en

cy o

f su

bje

cts


control

intervention

6

28

4

32

0

5

10

15

20

25

30

35

zero to < 4 days 4 days or more

Fre

qu

en

cy o

f su

bje

cts

Medication adherence

control

intervention

110

Logistic regression was used to test the influence of socio-demographic factors on glycaemic

control. Age and year of diagnosis of diabetes were associated with mean improvement in

glycaemic control. There was no association between the remaining socio-demographic factors

and mean improvement in glycaemic control. Table 4.7 summarizes the details.

Table 4.7 Logistic regression of factors associated with improvement in glycaemic control

FACTORS ODD’S

RATIO

95%

CONFIDENCE

INTERVAL

COEFFICENT STANDARD

ERROR

Z

STATISTICS

P – value

Age 1.0706 1.0103-1.1346 0.0683 0.0296 2.0305 0.021

Sex 1.0151 0.902 – 1.1423 0.149 0.0603 0.248 0.804

Year of

diagnosis

6.37 1.4085-28.808 1.852 0.77 2.405 0.016

Educational

status

Primary 1.667 0.398-6.974 0.511 0.730 0.699 0.484

Secondary 0.500

0.073-3.434 - 0.693 0.983 0.705 0.480

111

Tertiary 0.467 0.120-1.805 0.762 0.690 -1.104 0.269

Skills training 0.000 0.0000>1.0E12 -13.863 358.554 -0.0387 0.969

None 0.759 0.473-2.503 0.951 0.749 -1.386 0.148

Average

family

income

>60,0000 1.163 0.0380-35,545 0.150 1.744 0.0865 0.931

40,000-

60,000

6.364 0.267-151.596 1.850 1.617 1.144 0.252

20,000-

40,000

0.881 0.170-4.405 -0.126 0.820 0.153 0.878

<20,000 0.832 0.164-4.018 -0.409 1.731 0.172 0.813

Family

history of

DM

1.3802 0.356-5.002 0.288 0.674 0.427 0.669

4.9 Patient Assessment of Chronic Illness Care (PACIC) score in the intervention and

control groups

4.91 PACIC score at baseline

The mean PACIC scores in the control versus intervention group at the commencement of the

study were 1.18 ± 0.17 and 1.21 ± 0.20. There was no significant difference pre-intervention

112

between the two groups (t-test= 0.81, p=0.42). All the subjects had poor PACIC sores pre-

intervention. Details are summarized in table 4.8.

Table 4.8: PACIC score in subjects at baseline

Control group

N=38

N(%)

Intervention group

N=38 t-test

N(%)

p

value

Mean PACIC score 01.18 ± 0.17 01.21 ± 0.20 0.81 0.42

PACIC class: χ2

Good 0 (0.00) 0 (0.00) - -

Poor 38 (100) 38 (100)

4.92 Post-intervention PACIC score

At the end of twelve weeks, the mean PACIC score in the control group was 2.41 ± 0.26 versus

3.72 ± 0.28 in the intervention group. There was a higher mean increase in PACIC scores of

2.51 in the intervention group compared to 1.24 in the control group and this difference was

statistically significant. (t-test= 20.24, p<0.001). All 36 (100%) of the subjects in the

intervention group had a good PACIC score while no subject had a good score in the control

group. Details are summarized in table 4.9.

Table 4.9: Post-intervention PACIC score in subjects

Control group Intervention group

113

N=34

N(%)

N=36 t-test

N(%)

p

value

Mean PACIC score 02.41 ± 0.26 03.72 ± 0.28 20.24 0.000

Mean change 1.24 2.51 0.000*

PACIC class: χ2

Good 0 (0.00) 36 (100) -

Poor 34 (100) 0 (0.00)


4.10. ADHERENCE TO THE INSTRUCTION SHEET:

In the intervention group, at the end of the study, five subjects (28%) had adhered fully to the

instructions (defined as adhering to all items on the instruction sheet on all follow up visits)

while the remaining 31 (72%) individuals showed partial adherence. (figure 4.8-9).

The various reasons for partial adherence included inability to carry out regular aerobic

exercises due to lack of time as a result of work or school or family responsibilities.;

discouragement and inappropriate advice from family and friends; lack of financial

wherewithal to buy the required food items like fruits and vegetables; ill-health; forgetfulness;

sectarian crises; poor access to facilities due to distance to hospital permanent site and long

waiting time for card retrieval at records to see the ophthalmologist and dietician (figure 4.10).

Figure 4.8: Number of patients in the intervention group who adhered to self care

counselling instructions.

114

Figure 4.9: Number of patients in the intervention group who had self-management

goals and adhered to referral instructions.

Figure 4.10: Reasons for partial adherence

0

5

10

15

20

25

30

35

40

No

Yes

0

5

10

15

20

25

30

35

Have a selfmanagement

goal

Seen the dietician Seen theophthalmologist

Joined thediabetic

association

No

Yes

115

CHAPTER FIVE

5.0 DISCUSSION

40%

11%8%2%

36%

3%Financial constraint

ill health

lack of time

Family pressure to usetraditional medication

Difficulty in accessingservices at the hospital

Crises

116

Control of glycaemia is a priority in diabetes management and self-management is the

cornerstone of good diabetes care. Multiple studies have found that chronic care model (CCM)

is associated with increased diabetes knowledge, self-management behavior and improved

clinical outcomes such as lower HbA1c. This study sought to determine the effect of the chronic

care model on self-management behaviour and glycaemic control in adults with type 2 diabetes

with the view to recommending its use in routine care so as to ensure improved diabetes care.

At baseline, there were no significant differences between the control and intervention groups.

This may suggest that randomization was effective with regards to distribution of participants

in the groups. The attrition rate was 7.9%. This was less than the 10% used in calculating the

sample size and lower than that of 10% in a multifaceted randomized control trial by Piatt and

colleagues where the chronic care model was implemented.180

The study participants were between the ages of 36 years to 85 years with the greatest number

between the ages of 40- 69 years (80.3%) with a mean age of 55.5 years. The worsening of

insulin resistance with age, increased inactivity and longevity of diabetes patients due to

improved care are possible reasons for the rising prevalence of type 2 diabetes with age.39 The

figures in this study are similar to global figures which show that the greatest number of people

with diabetes are in the 40-59 age group.39,69 The mean age of 55.5 years found in this study is

similar to observations in Nigeria and other Sub-Saharan African countries where an age range

of 45-64 years was reported.39,69,98 In Nigeria, the risk of diabetes increases 3-4 times after the

age of 44 years.69 It was however low compared to reports from developed countries where

most diabetics were over 64 years of age. The lower mean age of diabetes compared with

patients in the developed world may be a reflection of the lower life expectancy of Nigerians

(average of 51.9 years in 2011) compared with the developed world (67 years to 84years), as

well as the reduced survival of Nigerian diabetic patients.39,69

117

There were more females (71.05%) than males (28.95%) in this study that is, a ratio of 2.5:1.

The sex distribution in this study is similar to the results of a multicentred study in seven centres

across the six geopolitical zones in Nigeria69 but does not reflect the pattern observed in studies

involving diabetic patients outside the tertiary health centres in Nigeria where the female:male

ratio is close to 1:1.43 Overall, diabetes prevalence is higher in men, but there are more women

with diabetes than men. The combined effect of a greater number of elderly women than men

in most populations and the increasing prevalence of diabetes with age is the most likely

explanation for this observation.16,183-4

The higher proportion of females in this study might have been due to the characteristic of the

study population, which consisted of more women presenting with type 2 diabetes mellitus at

the GOPD of JUTH. Unpublished data from the statistical unit of JUTH where this study was

carried out showed that over the last eight years, more women presented to the GOPD on a

daily basis than men with an average of two-thirds of the population being women from which

the study population was recruited.195

5.1 Self- management behaviour of the study group

Despite the increasing prevalence of type 2 diabetes in Nigeria; the self-management practices

of the general population is poor. At commencement of this study, there was no difference in

the self-management behaviour between the two groups with only 22% of subjects engaged in

regular aerobic exercise for four days or more in a week for the recommended 30 minutes.

These findings are consistent with findings from a multicentre study in Nigeria69 which showed

that only 35.9% of patients engaged in regular exercise Also, the findings that only 7.9% had

a healthy eating plan which involved eating fruits and vegetables, low fat diet reduction in

total food intake and salt intake is similar to a study by Okolie and colleagues in a secondary

care setting in Nigeria which showed that only 4.2% of patients knew about the beneficial

118

effects of healthy eating.185 Adherence to intake medication for four days or more in a week

was found in 60.5% of subjects, this is similar to findings by Kayode and colleagues in Ibadan

which reported a medication adherence of 54.8%.40 Poor patient understanding of diabetes is

believed to impede appropriate self-care management.69 This study showed that there was poor

knowledge and attitude about diabetes among type 2 diabetes patients; with only 15.8%

knowing what the blood glucose target was other studies in Nigeria have shown that only 6.4%

of patients had basic knowledge of diabetes management or care.40

After 12 weeks following the intervention; there was a significant improvement in self-

management behaviour. The difference was statistically significant between the two groups

with regard to diet and exercise. The number of subjects that were engaged in regular aerobic

exercise for four days and more in a week for the recommended 30 minutes or more increased

from13.1% to 44.1% in the control group and 7.9% to 63.9% in the intervention group

(p=0.03). The number of subjects that engaged in an eating plan that involved eating fruits and

vegetables, low fat diet, reduction in total food intake and salt intake for four days and more in

a week increased from 7.9% to 8.8% in the control group and 0 to 94.4% in the intervention

group (p<0.001). The medication taking behaviour also improved from 63.2% to 82.4% versus

57.9% to 88.9% in the group but the difference was not statistically significant (p=0.33).

Although there are no local studies to compare with, other studies have shown improvement in

self-management behaviour following interventions that foster patient self-management

behaviour.168,178-80 These findings are similar to those by Vallis and colleagues who examining

the long term effect of diabetes self-management education showed significant improvements

in adherence to most aspects of self-care, including medication use, self-testing, exercise, foot

care and general health behaviours like nutrition, exercise, and weight. Identification of goals

and achieving them increased substantially as a result of these strategies. Importantly, all of

119

these changes, with the exception of medication adherence, were sustained at the 2-year follow-

up.181

A randomized controlled trial by Piatt and colleagues showed that DSME/T, when

implemented within the context of the Chronic Care Model, improved clinical and behavioral

outcomes in an underserved community.180

This indicates that CCM interventions emphasizing self- management support was effective in

improving the self- management behaviour among the subjects.

5.2 Glycaemic control in the study groups

The mean HbA1c was 9.17± 2.56 in the control group; compared to 9.16± 2.20 in the

intervention group. Fifty- five (72.4%) subjects had a HbA1c ≥ 7% implying poor glycaemic

control. The remaining twenty-three (28.6%) had good glycaemic control. There was no

significant difference in the mean HBA1c (p>0.05) between the two groups at the

commencement of the study, implying the two study groups were comparable at baseline.

These findings are consistent with studies by Adebisi and colleagues in Ilorin which showed

that 64% of patients had poor glycaemic control.128-9 This has been attributed to poor self-care

practice and suboptimal management and poor compliance with global standards.16

At the end of 12 weeks there was a higher mean improvement in glycaemic control; though not

statistically significant in the intervention group (reduction of 1.11% in the intervention group

compared to 0.76 in the control group, p=0.46). This is similar to the finding of a study by

McAndrew and colleagues which did not show a significant improvement in glycated

haemoglobin over a short period144 but not consistent with other studies which showed a

statistically significant difference between groups.180-1 There was also a modest increase in the

percentage of those with good glycaemic control from 26.3% to 30.5%. The mean reduction of

120

1.11% is however comparable to that of 0.8- 0.93% observed in a meta-analysis. Vallis and

colleagues reported a reduction of 0.8 percentage point was observed in A1C levels following

interventions that emphasized self-management education.181 This study had a 80% power to

detect a change in HbA1c of 1% with 95% confidence. The inability to detect a difference may

be because the relatively short 12 week duration of the study was inadequate to detect a

difference compared to one year or more in other studies where there was an improvement. A

longer duration of study might show a more significant improvement in HbA1c in the

intervention group. It could also be because though the intervention wasn’t administered to the

control, the fact that they were participating in a study motivated them to make adjustments in

glycaemic control. A randomized controlled trial by Piatt and colleagues have also shown that

DSME/T, when implemented within the context of the Chronic Care Model, resulted in a

marked decline in HbA1c in the CCM group.180

Logistic regression of the influence of socio-demographic factors on glycaemic control showed

an association between improved glycaemic control and age and shorter duration of DM. This

finding is consistent with some studies165-8 but is contradicted by another report.169 The

worsening of glycaemic control over time could be explained by a reduction in pancreatic beta

cell function and an increased fat mass, particularly visceral adiposity, leading to greater insulin

resistance associated with the ageing process.

5.3 Patient Assessment of Chronic Illness Care (PACIC) score in the study group

At baseline, patient assessment of diabetes care using the Patient Assessment of Chronic Illness

Care scale showed low PACIC scores in this study at baseline. Other studies have reported low

121

PACIC scores.188-9 These scores have been determined to be significantly related to the quality

of diabetes care received suggesting that major improvements were required in chronic care.

There was a statistically significant higher mean improvement in PACIC scores post-

intervention in the intervention group of 2.51 compared to 1.24 in the control group (<0.001).

This implied a higher patient assessment of chronic illness care (PACIC) in the intervention

group following an intervention based on the chronic care model compared to the control group

that received usual care. All 36 (100%) subjects in the intervention group had good PACIC

scores post-intervention while none had good score in the control group.

These results indicate patient’s perception of greater involvement in self-management and

receipt of chronic care counselling following the CCM based intervention. It also shows that

CCM among patients with diabetes in JUTH resulted in greater patient motivation and support

by the physician to initiate changes. It also implies greater satisfaction with the organization of

care, adaptation of general instructions and suggestions to patient’s personal situation,

addressing of problems which interfered with achieving predefined goals and frequent follow-

up of the whole process of care.15 This finding is supported by studies by Schmittdiel and

colleagues which have shown that PACIC scores are significantly related to self-management

behaviour change.15,188-9

5. 4 Adherence to the Instruction Sheet:

Several reasons were given for partial adherence to the instruction sheet given to the

interventional group. They included lack of time as a result of work or school or family

responsibilities.; discouragement and inappropriate advice from family and friends; lack of

122

financial wherewithal to buy the required food items like fruits and vegetables; ill-health;

sectarian crises; forgetfulness; poor access to facilities due to distance to hospital permanent

site and long waiting time for card retrieval at records to see the ophthalmologist and dietician.

Financial constraint accounted for 50% of the reasons as source of financing was “out of the

pocket”. Adisa and colleagues in South western Nigeria which show that financial constraint

accounts for 35.5% of unintentional non-adherence and most patients pay for the treatment

“out of the pocket”.174-5 Poor access to facilities due to distance to the hospital permanent site

and protocol involved before specialists are seen accounted for 36% of reasons. This is an

important factor because it makes coordination of care and commitment to management plan

difficult on the part of the patients.

5.5 Strengths of the study

A major strength of this study is its design being a randomised single blinded control trial. Also

assessment of long term glycaemic control with HbA1c, which is not routinely done in our

environment was done at no cost to the patients.

5.6 Limitations of the study

There was a disproportionate male: female ratio in this study. Thus, the results of the study

may less likely be applicable to men. The reason for this may be that women are more likely

to present to the hospital and meet the inclusion criteria (this was a hospital-based study).

Due to the composition of the study groups, findings may not therefore be generalizable to

the wider population.

An important limitation was the short duration. Impact of the chronic care model on

glycaemic control is best seen over a longer period. A longer duration would have shown

if the improvements in self-management behavior and PACIC were sustainable.

123

5.7 CONCLUSION

The study demonstrated that people with type 2 diabetes experience improved self-

management behaviour after following interventions based on the chronic care model. Though

improvement in glycaemic control was observed, longer duration of study might be necessary

to establish the effect of CCM on glycaemic control. The study also showed a higher mean

improvement in patient assessment of chronic illness care (PACIC) in the intervention group

following patient self-management education. Hence indicating patient-centred self-

management support in line with the chronic care model was provided to the patients.

5.8 Recommendations

Patients’ knowledge and self-management practices were found to be poor in JUTH.

Hence provision of culturally appropriate diabetes self-management education is

essential. With structured guidelines, standardized and comprehensive diabetes self-

management education can be effected during a patient’s normal visit in resource poor

settings like the GOPD, JUTH.

Effective self-management and glycaemic control are the key outcomes of diabetic care

and should be measured and monitored as part of care

Re-organisation of the health care delivery system is needed to make patients have more

access to more services. Integrating self-management into routine care can help. Rather

than referring patients to a 30 or 60 minute appointment that would occur at another

time and location, focused encounters can take place during a patient’s normal office

visit. As a result, patients would receive more standardized and comprehensive care.

On-going advocacy, committed leadership and resources is vital for implementation

and sustenance of the CCM

124

Further research: Studies assessing the effect of the CCM based interventions are

needed in Nigeria. This study should be extended beyond the patients in the hospitals

to the communities in order to have a clearer picture of the impact of diabetes and effect

of CCM on self-management practices and glycaemia control on diabetics in Nigeria.

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APPENDIX A:

CONSENT FORM

INFLUENCE OF THE CHRONIC CARE MODEL ON SELF MANAGEMENT

BEHAVIOUR AND GLYCAEMIC CONTROL AMONG ADULT TYPE 2 DIABETICS

ATTENDING THE GENERAL OUT – PATIENT DEPARTMENT, JOS UNIVERSITY

TEACHNG HOSPITAL, JOS.

I am Dr Ega Olije Helen, a resident doctor in the department of Family Medicine of the Jos

University Teaching Hospital, Jos.

I am carrying out a study on the influence of the chronic care model on self –management

behaviour and glycaemic control among adults with Diabetes. This is to request for your

participation in the study.

Participation involves asking you some questions about your health condition and family. You

will also be seen at 4 weeks, 8 weeks and 12 weeks. In addition, you will be examined at each

visit and your blood glucose level assessed at each visit. Participation does not pose any risk to

you and is voluntary. Declining to participate does not affect your routine care in anyway.

You are free to withdraw from the study any time you wish. Confidentiality of any information

you give will be maintained.

147

I agree to participate in the study.

……………………………… ………………………………

Initials of consenting patient Initial of witness

……………………… ………………………………

Signature/Thumbprint Signature

………………. ………………………………

Investigator Signature

……………………

Date

APPENDIX B

THE STUDY QUESTIONNAIRE

ID NO…………. Consent Signed Yes ( ) No ( ) Date….. 2012

Subject Type Control….. Intervention……

Follow up date 4weeks ……..2012 8weeks ……..2012

12weeks .……2012

Demographic data

1. Initials: ……..

2. Age: ……… Years

3. Sex: Male ( ) Female ( )

4. Religion: Christianity ( ) Islam ( ) Traditional ( ) Others Specify (

)

5. Nationality: ……..……… State of origin ……………… Tribe……………

6. Contact Address: …………………………………………………………………...

………………………………..……………………………………………………….

7. Telephone Numbers ……………………………………………….

148

8. Educational Qualifications No formal ( ) Primary ( ) Secondary ( ) Tertiary (

) Skills training ( )

Medical History

1. Year of diagnosis

2. Fasting blood glucose ……………………………… (mmol/L)

3. What medications are you presently taking for your Diabetes?

Oral hypoglycaemic agents ( ) Insulin ( ) Both ( )

4. In the past 12months how many times have you been admitted? ………….

5. In the past 12 months, how frequently do you come for follow-up?

Every Month or less ( ) 8weeks ( ) 12weeks ( ) 6months ( )

6. Have you ever had any of the following in the past?

Hyperglycaemic crises ( ) Hypoglycaemic crises ( ) Stroke ( )

7. Do you have?

Hypertension ( ) Stroke ( ) Heart disease ( )

8. Are you taking medications for question 7 above? If yes name them

9. Do you consider the number of your medications plenty and find it difficult to comply?

Yes ( ) No ( )

10. Who pays for your drug treatment?

Yourself ( ) others ………………..

11. Do you know what your blood glucose target should be? Yes ( ) No ( )

12. Do you examine your feet regularly for corns, calluses or sores? Yes ( ) No ( )

Family and Social History

1. Occupation ( )

2. Marital status

Single ( ) Married ( ) Divorced ( ) separated ( ) widowed ( )

3. Number of siblings/children ( )

4. Family history of Diabetes Yes ( ) No ( )

5. Number of relations dead from complications of Diabetes ( )

6. Average family income per month in naira

<20,000 ( ) 20,000-40,000 ( ) 40,000-60,000 ( ) >60,000 ( )

7. Do you drink alcohol? Yes ( ) No ( )

If yes, how much quantity / week ……… (Indicate the number of standard drinks)

8. Do you smoke cigarette Yes ( ) No ( )

149

If yes, how many sticks do you smoke/day? ………..

9. How many servings of fruits and vegetables do you eat in a typical day? ………..

10. How often do you exercise? Daily ( ) Weekly ( ) Other ……….

11. What other life style modification strategies do you do to help with your diabetic control

Low fat diet ( ) Reduction in salt intake ( ) Other ………

APPENDIX C: Assessment of Care for Chronic Conditions: Validated PACIC

survey

Staying healthy can be difficult when you have a chronic condition. When would like to learn about

the type of help with your condition you get from your health care team. This might include your

regular doctor, his or her nurse, or physician’s assistant who treats your illness. Your answers will be

kept confidential and will not be shared with your physician or clinic.

Over the past 6 months, when I received care for my chronic conditions. I was:

None of A Little of Some of Mostof Always

1. Asked for my ideas when we the time the Time the Time the Time

made a treatment plan. 1 2 3 4 5

2. Given choices about treatment to

think about. 1 2 3 4 5

3. Asked to talk about any problems

with my medicines or their effects 1 2 3 4 5

4. Given a written list of things I

should do to improve my health. 1 2 3 4 5

5. Satisfied that my care was well

150

organized. 1 2 3 4 5

6. Shown how what I did to take

care of myself influenced my

condition. 1 2 3 4 5

7. Asked to talk about my goals in

caring for my condition. 1 2 3 4 5

8. Helped to set specific goals to

improve my eating or exercise. 1 2 3 4 5

9. Given a copy my treatment

plan. 1 2 3 4 5

10. Encouraged to go to a specific

group or class to help me cope

with my chronic condition 1 2 3 4 5

11. Asked questions, either directly or

on a survey, about my health

habits. 1 2 3 4 5

12. Sure that my doctor or nurse

though about my values, beliefs,

and traditions when they

recommended treatments to me 1 2 3 4 5

13. Help to make a treatment plan

that I could carry out in my daily

life. 1 2 3 4 5

14. Helped to plan ahead so I could

take care of my condition even in hard

times 1 2 3 4 5

15. Asked how my chronic condition

affects my life. 1 2 3 4 5

16. Contacted after a visit to see how

things were going. 1 2 3 4 5

151

17. Encouraged to attend programs in

the Community that could help

me. 1 2 3 4 5

18. Referred to a dietician, health

educator or counsellor. 1 2 3 4 5

19. Told how my visits with other

types of doctors, like an eye

doctor or surgeon, helped my

treatment. 1 2 3 4 5

20. Asked how my visits with other

doctors were going. 1 2 3 4 5

APPENDIX D: DIABETES SELF-MANAGEMENT INSTRUCTION SHEET

Initials: Date: / /

____________________________________________________________________

1. Try to maintain a healthy body weight. If you are overweight, reduce your

weight. Try to lose 0.5kg per week.

Your ideal weight ______kg

Your current weight ______kg

2. Limit alcohol intake to 1 drink per day.

3. Stop smoking.

4. Exercise regularly. Moderate-intensity physical exercises such as those listed

below at least 5 days a week are preferred:

Brisk walking for at least 30 minutes each day

Skipping for 15 minutes

Walking up and down stairs for 15 minutes

152

5. Diet: Eat plenty of fresh fruits and vegetables every day – at least five servings

each day.

Avoid eating food fried in oil, reduce oil in soups.

Reduce salt and maggi intake.

Eat only when hungry and stop eating when hunger is satisfied. Do not eat until full.

Use groundnut/soya oil for cooking instead of palm oil.

6.Adherence to medication: It is essential you follow the doctor’s advice and take all

your medication as prescribed.

Plan your medication intake around a daily routine

Have a family member or friend as a support partner to remind you

Set a reminder on your phone

Discuss any side effects noticed with your doctor.

7. Foot care:

Examine your foot for corns, calluses and sores daily

Cut your nails with care

Try and wear soft padded shoes

Examine the inside of your shoes before wearing it

8. Self-monitoring of glucose.

Use a glucometer to monitor your sugar( glucose) level at home

Be alert to signs of low sugar like sweating, excessive hunger, shaking, headache and

dizziness- have your sugar checked immediately and see a doctor; and take two cubes

of sugar or a sugar containing drink meanwhile

Be alert to signs of high sugar like excessive thirst and hunger, frequent need to urinate,

blurred vision, breathing problems – have your sugar level checked immediately and

see a doctor : meanwhile take any missed medication, drink several glasses of water

153

9. Referral to dietician: helps you to device a healthy diet plan from locally

available food.

10. Eye examination: it is important that your eyes are examined by an

Ophthalmologist annually; you can remind your doctor if it hasn’t been done.

11. Ensure you keep your appointments with the other doctors and health

professionals taking care of you.

12. Community participation: joining the local association of diabetics would help

you get support in the community.

13. Self -management goal:

It is important to have a goal in terms of what you want to achieve in terms of weight

loss, exercise and diet plans

Review it regularly (e.g. weekly) to see if you are on track

Discuss any perceived obstacles with your doctor

_____________________________________________________________________

Your next appointment is: Date: / / / 4 weeks

Date: / / / 8 weeks

Date: / / / 12 weeks

154

HAUSA TRANSLATION

TAKARDAN SHARUDAN KULA DA CIWO MAI DOGON JINYA

1. Ayi kokari akula da nauyin jiki. Idan nauyin jiki yayi yawa, a yi kokari arage rabin kilo

daya na nauyin jiki kowani sati.

- Nauyin jiki da ya dace ……. Kg

- Nauyin jiki ta yanzu ………. Kg

2. A rage shan giya zuwa sau daya a rana.

3. A dena shan taba.

4. A dinga motsa jiki akai akai. Motsa jiki dai de irin wadan aka lisafa a kasa so biyar a

sati. A ta ka ice aka fison mutum yayi:

- Takawan shan iska ta minti talatin kowace rana

- Tsale tsale ta minti goma sha biyar

- Hawa da sauka daga gidan sama ta minti goma sha biyar

5. Abinci mai gina jiki: a rika cin yayan itatuwa da ganye kowace rana sosai, kamar sau

biyar a rana

- A guje cin soyayyen abinci, arage yawan maiko a miya

155

- A rage cin gishiri da maggi

- A cin abinci da muddin yunwa ya shiga, a kuma tsaya muddin an koshi. Kar a ci

har ciki ya cika so sai

- A yi amfani da man gyada ko man waken soya wajen dahuwa a maimakon man ja

6. Shan magani a daidaice: ka bi ka’idodin likitan ka ta wajen shan magani

- Shan magani ya bi abubuwan da ka saba yi kowace rana

- Ka samu wani a cikin yanuwan ka ko abokanen ka ya zama mai tuna maka da shan

magani

- Ka yi amfani da wayar ka ta wurin tunawa da shan magani

- Ka tattauna da likitanka game da duk illan da ka samu da magani

7. Lura da kafa:

- Duba kafafuwan ka kowace rana domin neman kumburin yatsu ko wani ciwo na

musamman

- A kiyaye wajen yankan farce

- A yi kokari a sa takalma masu laushi

- A duba cikin takalma kafun a sanya

8. Kaluwa da sugar na jini da kan ka:

- A yi amfani da na’uran sanin adadin sugar gida

- Hankaltuwa da alamun karancin sugar Kaman gumi ko zufa , yawan jin yunwa,

girgizan jiki, ciwon kai da jiri. A duba sugar ka nan da nan sai ka tafi wajen likitan

ka. Kafun nan, ka sha kwayoyin sugar guda biyu ko wani ruwan sugar kamar lemun

kwalba

- Ka kula da alamun yawan sugar a cikin jini kaman yawan kishin ruwa, yunwa,

yawan fisari, rashin gani da kyau da kuma damuwa da numfashin ka

- Ka sha ruwa mai yawa

156

- In baka sha maganin ka ba, ka yi kokari ka sha

9. Zuwa ganin ma’aikatan abinci masu gina jiki: zai taimaka wajen hade haden abinci

masu gina jikin dabam dabam da aka fi samu cikin angwa

10. Gwajin idanuwa: yana da muhimmanci likitan ido ya duba idanuwan ka ko wane

shekara. Za ka iya tuna ma likitan ka idan ba”a riga anyi maka gwaji ba

11. Ka yi kokari ka aje alkawarin ka da sauran likitoci da ma’aikatan kiwon lafiya masu

lura da kai

12. Shiga cikin al umma tare da hadin kan kungiya ma su ciwon sugar zai taimaka wurin

samun taimakon al umma

13. Tsara kulawa da kai: yana da muhimmanci a tsara bukata yin nasara wurin rage nauyin

jiki, motsa jiki da tsarin abinci

- A dunga kulawa akai akai misali kowane sati don ka gane ko kana kan hanya

- Ka tattaauna da likitan ka game da duk wani abun da zai hana ka samun bukaturi

ka

Ranar da wo wa: Date: / / / Sati hudu

Date: / / / Sati takwai

Date: / / / Sati goma sha biu

157

APPENDIX E: SELF MANAGEMENT BEHAVIOUR RECORDS

Did you keep to the instruction

sheet?

Yes[ ] No [ ]

Initial 4 weeks 8 weeks 12 weeks

Are you trying to lose weight? Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ] No[

]

Yes [ ]No [

]

Have you reduced your total food

intake?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes[ ] No [

]

Do you take fresh fruits and

vegetables each day?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

Have you reduced intake of fried

foods?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

Have you changed to groundnut oil

for cooking?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

Have you reduced the oil in your

food?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

Have you reduced salt and maggi

intake?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

Do you examine your feet daily? Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

Have you seen the dietician as

referred?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

158

Have you seen the Ophthalmologist

as referred

Yes [ ] No [

]

Yes [ ] No [ ] Yes [ ]No [

]

Yes [ ]No [

]

Have you joined the local diabetic

association?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

Do you have a self- management

goal?

Yes [ ] No [

]

Yes [ ] No [

]

Yes [ ]No [

]

Yes [ ]No [

]

EXERCISE RECORD

Initial 4 weeks 8 weeks 12 weeks

Brisk walking

Skipping

Jogging

Cycling

Bicycling

Tennis

Football

Other

How many days

did you exercise?

How many

minutes/ day?

What were the major obstacles in keeping to the instruction sheet?

159

1 .……………………………………………………………………………………………

2 ………………………………………………………………………………………………

ADHERENCE TO MEDICATION

Did you take the prescribed medications? Yes ( ) No ( )

How many days did you miss your medication? 0 ( ) 1 ( ) 2 ( ) ≥3 ( )

Reasons for missed medication

……………………………………………………………………………………………

Appendix F: Ethical Clearance

160

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