Influence of Stroke Riskometer on Making Lifestyle Changes Among Urban Dwelling Malaysian Stroke Caregivers: A Pilot Randomised

Controlled Trial

RESEARCH THESIS PROPOSAL

BY

DR RADHIYAH HUSSINP80937

UNIVERSITY KEBANGSAAN MALAYSIA

SUPERVISOR:

Assoc. Prof Dr Aznida Firzah Abd. Aziz,Family Medicine Consultant & HeadDepartment of Family MedicineFaculty of MedicineUKM Medical Centre

Co-supervisor:

Dr. Ezura Madiana Md. MonotoFamily Medicine Specialist & LecturerDepartment of Family MedicineFaculty of MedicineUKM Medical Centre

1

TABLE OF CONTENTSCHAPTER 1: Introduction....................................................................................................................5

CHAPTER 2: Review of Literature.......................................................................................................6

2.1 Primary prevention of stroke.......................................................................................................6

2.2 Influence of mobile health application in behavioural changes...................................................6

2.3 Stroke Riskometer.......................................................................................................................7

2.4 Caregiver strain...........................................................................................................................8

2.5 Definition of Terms.....................................................................................................................8

CHAPTER 3: Justification of study/study rationale..............................................................................9

CHAPTER 4: Research Question..........................................................................................................9

CHAPTER 5: Objectives of the study...................................................................................................9

5.1 General objective.........................................................................................................................9

5.2 Specific objectives.......................................................................................................................9

CHAPTER 6: Research methodology...................................................................................................9

6.1 Study design................................................................................................................................9

6.2 Study setting................................................................................................................................9

6.3 Study period................................................................................................................................9

6.4 Study population........................................................................................................................10

6.5 Sampling method.......................................................................................................................10

6.6 Inclusion criteria........................................................................................................................10

6.7 Exclusion criteria.......................................................................................................................10

6.8 Sample size estimation..............................................................................................................10

6.9 Study Instrument........................................................................................................................11

6.9.1 Data collection forms.............................................................................................................11

6.9.2 Two Questions with Help Question (TQWHQ).....................................................................11

6.9.3 Life’s Simple 7......................................................................................................................11

6.10 Study Recruitment...................................................................................................................14

6.11 Data collection method............................................................................................................15

6.13 Data analysis............................................................................................................................18

6.14 Ethical consideration...............................................................................................................18

CHAPTER 7: Gantt chart....................................................................................................................19

CHAPTER 8: Budget..........................................................................................................................20

CHAPTER 9 References.....................................................................................................................21

APPENDICES A: Patient’s information sheet and consent.................................................................23

2

APPENDIX A.1 English version.....................................................................................................23

INFORMATION SHEET.................................................................................................................23

INFORMED CONSENT FORM......................................................................................................27

APPENDIX A.2 Malay version......................................................................................................29

RISALAH MAKLUMAT PESERTA DAN.....................................................................................29

BORANG PERSETUJUAN/ KEIZINAN PESERTA.....................................................................35

APPENDIX B..................................................................................................................................37

PART 1: DATA COLLECTION FORM.........................................................................................37

PART 2: Life’s Simple 7 (to be filled by researcher).......................................................................40

APPENDIX C: Permission to use Stroke Riskometer Application and Life’s Simple 7..................42

3

CHAPTER 1: Introduction

Stroke is a global public health crisis as reported by World Health Organization in 2015, 6.5 million people died due to stroke (1). By 2020, it is estimated 60 million people will be left permanently disabled from stroke (2). In Malaysia, we are not spared either as 6 new stroke cases will occur every hour (3). In Malaysia, post stroke patients seen in primary care facilities are usually in the younger age group with the mean age of 56.3 (4) as compared to those in the tertiary centre who present with mean age of 62.7 years (5). Primary prevention is the most effective and offers the best opportunity to reduce stroke burden as almost 80% from first time stroke attack are caused by modifiable risk factors such as hypertension, hypercholesterolemia and smoking (6). It is crucial to prevent stroke from happening at first place as stroke can cause deleterious effect not just on the stroke survivor themselves but also on the stroke caregiver (7).

The physical and mental sequelae of caregiving for stroke patients can cause significant negative impact on the caregiver and subsequently making them at risk of getting stroke themselves. Study has shown that male caregivers, with high caregiving strain and advanced age in lower educational groups are susceptible to get stroke (7).

Apart from the knowledge on familial link of getting stroke, if these caregivers knew their objective evaluation of their stroke risk, would it help to promote them in making lifestyle changes that would be beneficial to their own health? Our research would like to explore on the impact of the awareness on getting stroke by using a mobile health application developed by Professor Valery Feigin from Auckland University of Technology’s National Institute for Stroke and Applied Neurosciences.

The Stroke Riskometer application (SRA) is an app developed in 2014 with the aim to assess the risk of stroke and simultaneously provide education and motivation for users, ranging from age 20 to 90 years old. It can estimate a person’s risk of getting stroke within 5 and 10 years. Armed with this information, users can take action in order to reduce their risk by making lifestyle changes and adherence to medical treatment.

The SRA has been validated against two commonly used stroke prediction algorithms

(Framingham and QStroke) and endorsed by the World Stroke Organisation (8). It has been translated into 8 different languages, which includes Bahasa Malaysia. All users’ data can be saved, be compared over time and also provides practical and reliable tips for lifestyle changes given by renowned researchers and experts in the field.

4

CHAPTER 2: Review of Literature

2.1 Primary prevention of stroke.

Healthy lifestyle has always been admired for its positive impact on overall morbidity and mortality of human beings (9). It has been proven that people, who never smoked, consumed healthy diet which includes daily consumption of adequate amount of vegetables, fruits, protein and grain, and limiting intake of sodium, fat and also ensuring varieties of food taken on a daily basis, perform adequate physical activity such as participating 3 or more times per week in an activity with a metabolic equivalent level of 6 or more for participants who were aged 60 years or older and 7 or more metabolic equivalents for participants who were younger than 60 years, and moderate alcohol consumption (i.e. defined as men who reported consuming 60 or fewer drinks per month, and women who reported consuming 30 or fewer drinks per month,) were each significantly associated with lower risk of mortality (10, 11).

According to Chiuve SE et al. in a prospective cohort study among 43,685 men from the Health Professionals Follow-up Study and 71,243 women from the Nurses' Health Study, among the women, 47% of total and 54% of ischaemic stroke cases were attributable to absence of devotion to a low-risk lifestyle. For male participants, 35% of total and 52% of ischaemic stroke may have been prevented. It was again proven that healthy lifestyle habit significantly reduced risk of cerebrovascular accident particularly ischaemic stroke (10)

O’Donnel et al, in the INTERSTROKE study recruited people from 142 centres in 32 different countries worldwide, including low-income and middle-income countries. The researchers identified ten risk factors that were significantly associated with risk of any stroke; high blood pressure (over 140/90mmHg), current smoking, high alcohol intake, high waist-to-hip ratio, high Apolipoprotein B/A1 ratio, diabetes, psychosocial factors (based on the INTERHEART stress score) and heart factors (combined). A healthy diet and maintaining active lifestyle were linked with decreased risk of stroke (6). The researchers calculated that overall, these ten risk factors could account for 90.7% of all the strokes in the study. That is, if everyone acted on these risk factors, the number of strokes in this sample would reduce drastically by 90%. (6)

2.2 Influence of mobile health application in behavioural changes.

Globally, mobile phones have achieved wide coverage at an unprecedented rate, and mobile phone applications or apps have become increasingly prevalent among users. There has been a surge of health-related mobile phone apps in recent years. The number of health-related apps released on the two leading platforms, iPhone operating system (iOS) and Android, had reached more than 100,000 in 2014. With this new technology at patients’ and health care professionals’ (HCPs) fingertips, people are changing the way they interact.

Apps used in health care settings have several functions or address different aspects, such as information and time management, communication and consulting, patient

5

management and monitoring, health record maintenance and access, reference and information gathering, and clinical decision making (12).

Malaysia’s expansion of its smartphone market is expected to hold steady at around 1 percent annually in the coming years. In 2015, there were around 14.5 million smartphone users in the country. This number is projected to grow to more than 20 million in 2020. In 2015, about 45 percent of smartphone users in the country made purchases on their smartphones, By 2016, Samsung was the market leader among all smartphone vendors in Malaysia, with an almost 33 percent market share, followed by Apple with a 13.1 percent share (13).

In 2017, 19.06 million people accessed the internet through their mobile phone. In 2021, this figure is projected to amount to 21.29 million mobile phone internet users. 20 % of the Malaysians are using their mobile phones for social media purposes, 15% for checking emails and 9% to make online purchase (13).

Apps appear to be an ideal platform to deliver both simple and effective interventions. Due to the possible positive implications for public health, there is an increasing interest from commercial companies, government agencies, public health organizations, and the general public to utilize apps as a tool for health behavioural change(14). According to Jing Zhao et al. there were 17 studies which reported statistically significant effects in the direction of targeted behaviour change, commonest being self-monitoring. One of the primary benefits of apps is their potential for incredibly high reach or coverage (14).

With mobile phone use reaching near saturation among some populations, particularly young adults, and the high rates of consumer acceptability, Apps that offer even a small health benefit could still be a valuable public health intervention tool or medium, if the population-level reach is high enough(15). The mobile phone networks have attained a high degree of market penetration, whether in underdeveloped or developing nations beyond the limits of other infrastructure such as paved roads and electricity, and surpass fixed Internet deployment. The highly evolved networks have been providing elevated speeds of data transmission. Apace with being more economical and high performance cell phone, health information and services are rendered more reachable and convenient. With increased accessibility comes the possibility of greater personalisation and citizen-focused public health and medical care (15)

2.3 Stroke Riskometer.

A new app The Stroke Riskometer, has been developed for iOS and Android devices, by Professor Valery Feigin from AUT’s National Institute for Stroke and Applied Neurosciences in 2014, aiming to reduce the incidences of stroke by assessing risk of stroke using Framingham stroke risk algorithm. The Stroke Riskometer takes into account diet, physical inactivity, alcohol, stress, family history of stroke or heart attack, and ethnicity, plus other medical illness thus allowing more accurate estimate of the risk. The result is presented as a percentage chance of suffering a stroke in the next five and ten years and compared with someone of the same age and sex without contributing risk factors, providing a relative risk of having a stroke for the person concerned. It motivates users to make positive changes to

6

their lifestyle. Users can also monitor the change in their risk of suffering a stroke to determine the impact of risk factor modification on the risk of stroke.

The Stroke Riskometer(TM) is comparable in performance for stroke prediction with The Framingham Risk Score and the QStroke which is a risk prediction algorithm that calculates an individual’s risk of ischaemic stroke taking account of their individual risk factors (8). Stroke Riskometer™ was derived from the Framingham Stroke Risk score prediction algorithm but enhanced to include several additional risk factors shown to be important for both ischaemic and haemorrhagic strokes such as poor diet, low physical activity, high alcohol consumption, experienced emotional stress and cognitive status(16).

By advocating prevention of stroke or cardiovascular disease in lower risk or no risk individuals, we are optimistic that this approach will be more efficient at detecting and reducing the risk altogether. It is more engaging and patient centred by utilising modern technologies which is easily accessible and more cost effective(12). Preventive strategies similar to the Stroke RiskometerTM could be developed for other non-communicable disorders for which reliable predictive models and preventative recommendation exist. This would help reduce the burden of non-communicable disorders worldwide.

2.4 Caregiver strain

According to a study done by Hussain et al. in 2014, 3.8 million Malaysian are caregivers, and generally they are family members (17). Family members will provide assistance in activities daily living (ADL) of stroke patients either during admission or at home such as toilet needs, grooming, feeding and mobilisation (18, 19). Tending for them becomes a demanding duty both physically and emotionally, especially when the caregiver takes upon a sudden responsibility without prior exposure or training(17, 20) . Many post stroke survivors become dependent on their caregivers as they are restricted to long term impairments in physical, psychosocial and cognitive function (7). In Malaysia, Othman et al reported a prevalence of 25% on caregiver strain among caregivers of elderly (i.e. above 60 years old) stroke patients (20).

Caregiver strain also increases the risk of stroke amongst caregivers. Participants in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study assessed the risk of stroke (16). These authors reported high caregiver strain was associated with elevated stroke risk. Higher stroke risk scores were related with male gender, African American race, advanced age, low education, greater depressive symptoms and high caregiving strain (7).

2.5 Definition of Terms

Influence is defined as the capacity to have an effect on the character, development, or behaviour of someone or something, whereas lifestyle means the way in which a person lives.

Caregivers: According to Family Caregiving Alliance 2001, caregivers are any person who provides assistance to someone else who is to some degree, incapacitated and needs help. In

7

Malaysia, generally caregivers are immediate family members for example spouse, children, siblings or parents (17).

CHAPTER 3: Justification of study/study rationale

To date, there is no study concerning primary prevention of stroke among caregivers using any mobile application has ever been conducted either locally or globally, specifically using the SRA. Thus, this study is aimed primarily to gather percentage of people who already know they are at risk of getting stroke and what preventive measures have been taken to prevent it. The finding of this study may guide primary care physicians to help increase awareness on risk of stroke among a susceptible population i.e. caregivers of stroke and enhance primary prevention for stroke as well as other non-communicable diseases as well.

CHAPTER 4: Research Question

The research question of this study is:

Would knowing the risk of stroke empower stroke caregivers to make lifestyle changes?

CHAPTER 5: Objectives of the study

5.1 General objective

To determine the feasibility of Stroke Riskometer Application to influence lifestyle changes in stroke caregivers.

5.2 Specific objectives

1) To assess the sociodemographic and clinical characteristic of stroke caregivers.2) To assess risk of stroke among stroke caregivers at 5 and 10 years.3) To determine the lifestyle changes of stroke caregivers within 3 months after

knowledge of personal stroke risk assessed by Stroke Riskometer as measured by Life’s Simple 7 questionnaire.

CHAPTER 6: Research methodology

6.1 Study design : Prospective, randomised controlled trial, single blinded towards Study subject.

6.2 Study setting : Klinik Lanjutan Strok, Klinik Primer Pusat Perubatan Universiti Kebangsaan Malaysia, Cheras (KPPC)

6.3 Study period : June 2018- May 2019.

8

6.4 Study population: Caregivers of stroke patients attending Klinik Lanjutan Strok.

6.5 Sampling method:

Sample will be gathered by doing simple random sampling through a numbered list of stroke patients attending Klinik Lanjutan Stroke (KLS) in Klinik Primer.

Currently there are 190 post stroke survivors listed in the KLS appointment book. All 190 names will be arranged in a numbered list from 1- 190. Balloting method will be done to select a total of 80 patients. Then out of the 80 patients, 40 will be elected again to be in the Interventional group while the remaining 40 will be in the control group. The method used to distinguish whether sample will be in the intervention or control group is using a coin, which is tossed by a person who is a non-researcher. Upon seeing the patient in person during appointment, a coin will be tossed to determine their allocation. If the coin shows heads, they will be allocated in the intervention group and if it is the tails, they will be placed in the control group. Their caregivers will be informed and approached either personally during consultation or contacted via telephone to get further details.

If the caregivers are interested they will be given an appointment date to come to the clinic for baseline assessment and consent. Once recruitment begins, successive participants will be given a sequential study number.

6.6 Inclusion criteria : i. Aged at or more than 18 years old.

ii. Owns a smartphone and knows how to use it.iii. Able to read and speak either in Bahasa Malaysia or English.

6.7 Exclusion criteria:

i. The care recipient i.e. post stroke patient resides in nursing home.ii. Pregnant caregivers. Enrolling pregnant mother to this trial for

intervention and advices might affect their own health and the unborn foetus for example encouraging on low calorie diet or moderate intensity exercise. As some pregnancy might be entered in different trimester, their baseline assessment of weight, blood pressure, cholesterol will be remarkably different due to hormonal and physiological changes.

iii. Stroke caregivers with possible depression (i.e. Respondents with positive score on the Two Question With Help Questionnaire i.e. a screening tool for depression

6.8 Sample size estimation

For our pilot study, the sample size will be 36 subjects in each arm after referring to Billingham SA et al. (21). It is expected there will be 10% drop out thus a total of 40 participants will be assigned in each arm. Overall total sample size for our study will be 80 participants. Intension to treat analysis will be used, with last observation carried forward will be employed for participants who did not turn up for assessment visits. This is based on the

9

assumption that the participants’ last recorded response and/ clinical state remained unchanged or status quo at the exit assessment visit.

6.9 Study Instrument

6.9.1 Data collection forms

Patient-specific details ranging from assessment made when determining eligibility, the randomized intervention actually allocated and details of progress during the active intervention phase to long term follow up information of respondent/caregiver or care recipient/ post stroke patient will be recorded on the case record forms. The data collection form will be filled up by researcher during a baseline assessment interview. It will contain: • participants’ age, gender, race, nationality, • occupation, marital status, education background, income monthly, • past medical or current medical illness, mental illness, family history, • caregiving status and their relationship to the stroke patient/ care recipient and • their smartphone duration of usage per day and its purpose on daily basis.

The following vital signs assessments will be performed and recorded in the form: • Body weight (kg) and height (cm), no shoes in light clothing• Pulse in beats/min, taken at the radial artery over 60 seconds, after 5 minutes rest

prior to BP measurements, once in the sitting position. • Blood pressure will be measured with a mercury sphygmomanometer, once in the

sitting position after 5 minutes rest measurements should be taken with a 2 minute interval between measurements.

BP should be measured by the same study personnel whenever possible and on the same arm. All measurements should be to the nearest 2 mmHg. Diastolic BP is determined at Phase V (i.e. disappearance of the Korotkoff sound). The readings will be recorded in the data collection form. Participants will be asked regarding their lifestyle according to Life’s Simple 7 questionnaire.

6.9.2 Two Questions with Help Question (TQWHQ)

Two Questions with Help Question (TQWHQ) questionnaire is self-administrated case-finding instrument for depression. The questionnaire is brief, reliable and has been validated as a screening tool for depression in primary care setting. This questionnaire has been validated in Bahasa Malaysia language, with sensitivity and specificity of 99% and 70% respectively (22).

6.9.3 Life’s Simple 7

Life's Simple 7 is a new metric based on modifiable health behaviours and factors that the American Heart Association uses to promote improvements to cardiovascular health (23).

10

We calculated baseline Life's Simple 7 score (range, 0 to 14) based on smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and fasting glucose. Respondents will be interviewed and answer will be given by recall method. There are four main health behaviours (smoking, weight, physical activity and diet) and three health risk factors (total cholesterol, blood pressure and fasting blood glucose) listed in the metrics. Scoring will be done and classified according to poor, intermediate and healthy lifestyle(23).The end point of the assessment will be the score of Life’s Simple 7.

After baseline assessment has been completed, all participants regardless of which group do they belong to, will be going through risk of getting stroke assessment by using Stroke Riskometer Application conducted by researcher.

6.9.4 Stroke Riskometer Application

The intervention tool used in this study is a validated Stroke Riskometer application which can be downloaded via iOS and Google Play. The app contains 20 questions specifically designed to assess participants’ modifiable and non-modifiable risk factors(8). The application is available in English and Bahasa Malaysia version.

Data obtained through the application will be recorded in google form. The collected data will be grouped into 3(three) domains;

Part A: Non modifiable risk factors: age, gender and race Part B: Modifiable risk factors: Smoking status, excessive alcohol consumption, physical activities, healthy diet, family history of stroke, diabetes,

Hypertension, atrial fibrillation, dementia. Part C: Percentage of stroke risk calculated in 5 and 10 years of time.

At initial assessment, participants will be doing the questions in the application with assistance from researcher. Upon entering the trial, only participants in the intervention group will be receiving Stroke Riskometer downloaded into their smartphones. They will be assessed again after 12 weeks of trial and analysed the data obtained.

Permission to use the SRA has been obtained from the original copyright owner of the app i.e Professor Valerie Feigin from AUT’s National Institute for Stroke and Applied Neurosciences.

11

12

6.10 Study Recruitment

A list of all the stroke patients attending Klinik Lanjutan Stroke KPPC will be used as the sampling frame. Potential participants will be identified via simple random sampling method described previously.

Caregivers who meet the inclusion criteria will be approached during their visit to KLS with the patient and recruited for the trial. Verbal consent will be taken and they will be briefed regarding the study protocol. They will also be informed regarding the randomization for intervention types in the study. Participants will be blinded to the type of intervention received during the trial.

Participants who agree to participate in this trial will be asked to sign a written consent during interview the participants’ mental health status will be screened using Two QuestionWith Help Question. If found to have symptoms of depression. They will then be referred to the primary care team for further evaluation and necessary treatment.

Findings of the study and the feedback will be offered to the participants upon completion of the study. It will be emphasized that this study is totally voluntary and no discrimination will be given if they refuse to take part in this study. Similarly if they do agree to participate, they are free to withdraw at any time during the study if they change their mind.

13

6.11 Data collection method

The caregivers accompanying post stroke patients at Klinik Lanjutan Strok will be approached during the study period, as mentioned previously. The data collection will be conducted as per the illustration below.

14

15

Klinik Lanjutan Strok Klinik Primer Cheras stroke patient and their caregiver

Screen for possible depression with TQWHQ

Yes No

Exclude and alert primary care team for

further assessment

Recruit and randomize

Control (n=40) Intervention (n=40)

Risk of stroke calculated with Riskometer in percentage

Risk of stroke calculated with Riskometer in percentage

Assess Life’s Simple 7 score and given general advice

Assess Life’s Simple 7 score and given general advice

Inclusion criteria

16

No application downloadedStroke Riskometer

downloaded, teach how to use

Review in 3 months and reassess stroke risk and LS7

Review in 3 months and reassess stroke risk and LS7

Identify risk and refer, exit trial and analyse

Refer patients who require stroke risk factor intervention / symptomatic

6.13 Data analysis

The statistical application software that will be used to analyse the data collected from the questionnaire is SPSS (Statistical Package for the Social Sciences) version 23. Data will be keyed into the SPSS software. Descriptive statistics will be utilized to summarise the socio-demographic characteristics of subjects as well as to measure their stroke risk and risk factors Descriptive results will be presented using frequencies, percentages, means, standard deviations, medians and interquartile ranges. Inferential statistics will be done using appropriate parametric or non-parametric bivariate analysis, followed by multivariate linear regression. The level of significance is set at a p-value of <0.05.

6.14 Ethical consideration

1. Approval from the Research & Ethics Committee of Universiti Kebangsaan Malaysia will be obtained first before registrations with the National Medical Research/ Registry (NMRR).

2. Trial will be registered with ICJME compliant public registry before trial commences (Australia-New Zealand Clinical Trial Registry- www.anzctr.org.my).

17

CHAPTER 7: Gantt chart

GANTT CHART

June’16- Mac’17

Mac’ 17

Apr -Sept’ 17

Sept’17-June’18

June ’18 - Aug’ 18

Sept’18-Nov’18

Dec’18

Jan’ 19

Literature review & proposal preparation

√ √ √ √ X

Proposal presentation

√

Proposal write upAbstract for proposal

√

Submission to ethics for approval

√

Data collection XData analysis and write up

X

First draft submission to department

X

Final manuscript submission

X

18

CHAPTER 8: Budget

ITEM ESTIMATED COST

Research materials and supplies;

• Printing for informed consent and patient information sheet: 10pcs/set @0.10sen/pc x 100 sets

RM0.10X10 sheets+RM1.00

RM1.00X100 =

RM 100.00

Registration : 80 x RM 53/ pax RM 4240.00

Blood tests :Fasting blood sugar + fasting Serum Lipid : 80 x RM10/pax only during entry assesment

RM 800.00

Transportation :80 x RM30/ pax (for exit assessment visit only)

RM2400 .00

TOTAL RM7540.00

19

CHAPTER 9 References

1. World Health Organization 2017. source Global Health Observatory (GHO); 2017.2. Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. The Lancet Neurology. 2009;8(4):355-69.3. Loo KW, Gan SH. Burden of stroke in Malaysia. International Journal of Stroke. 2012;7(2):165-7.4. Aziz AFA, Aziz NAA, Sulong S, Aljunid SM. Identifying post stroke patients in the Malaysian community: Profile of patients managed at ten selected public health centres in Peninsular Malaysia. BMC Public Health. 2014;14(S1):P20.5. Aziz ZA, Lee YY, Ngah BA, Sidek NN, Looi I, Hanip MR, et al. Acute Stroke Registry Malaysia, 2010-2014: Results from the National Neurology Registry. Journal of Stroke and Cerebrovascular Diseases. 2015;24(12):2701-9.6. O'Donnell MJ, Chin SL, Rangarajan S, Xavier D, Liu L, Zhang H, et al. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study. The Lancet. 2016;388(10046):761-75.7. Haley WE, Roth DL, Howard G, Safford MM. Caregiving strain and estimated risk for stroke and coronary heart disease among spouse caregivers. Stroke. 2010;41(2):331-6.8. Parmar P, Krishnamurthi R, Ikram MA, Hofman A, Mirza SS, Varakin Y, et al. The Stroke RiskometerTM App: Validation of a data collection tool and stroke risk predictor. International Journal of Stroke. 2015;10(2):231-44.9. Eriksson KM, Westborg C-J, Eliasson MC. A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors The Björknäs study. Scandinavian Journal of Social Medicine. 2006;34(5):453-61.10. Chiuve SE, Rexrode KM, Spiegelman D, Logroscino G, Manson JE, Rimm EB. Primary prevention of stroke by healthy lifestyle. Circulation. 2008;118(9):947-54.11. Ford ES, Zhao G, Tsai J, Li C. Low-risk lifestyle behaviors and all-cause mortality: findings from the National Health and Nutrition Examination Survey III Mortality Study. American journal of public health. 2011;101(10):1922-9.12. Ventola CL. Mobile devices and apps for health care professionals: uses and benefits. Pharmacy and Therapeutics. 2014;39(5):356.13. The daily smartphone usage in Malaysia;. 2017.14. Zhao J, Freeman B, Li M. Can mobile phone apps influence people’s health behavior change? An evidence review. Journal of medical Internet research. 2016;18(11).15. Sarfo FS, Ovbiagele B. Mobile health for stroke: a promising concept for research and practice. mHealth. 2017;3.16. Thacker EL, Gillett SR, Wadley VG, Unverzagt FW, Judd SE, McClure LA, et al. The American Heart Association Life9s Simple 7 and Incident Cognitive Impairment: The REasons for Geographic And Racial Differences in Stroke (REGARDS) Study. Journal of the American Heart Association. 2014;3(3):e000635.17. Hussain NA, Abdullah MR, Esa AR, Mustapha M, Yusoff N. Predictors of life satisfaction among family caregivers of hospitalized first-ever stroke patients in Kelantan. Norhayati Mustapha Case Reports. 2014;220:164.18. Hairi NN, Bulgiba A, Cumming RG, Naganathan V, Mudla I. Prevalence and correlates of physical disability and functional limitation among community dwelling older people in rural Malaysia, a middle income country. BMC Public Health. 2010;10(1):492.

20

19. Nor Azlin M, Rizal A, Wei Bi L. Health related quality of life (HRQoL) among stroke survivors attending rehabilitation centers in Selangor. Malays J Community Health. 2009;15:83-90.20. Othman Z, Wong ST, Drahman I, Zakaria R. Caregiver Burden is Associated with Cognitive Decline and Physical Disability of Elderly Post-Stroke Patients. Middle-East Journal of Scientific Research. 2014;22(9):1265-71.21. Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC medical research methodology. 2013;13(1):104.22. Mohd-Sidik S, Arroll B, Goodyear-Smith F, Zain AM. Screening for depression with a brief questionnaire in a primary care setting: Validation of the two questions with help question (Malay version). The International Journal of Psychiatry in Medicine. 2011;41(2):143-54.23. Lloyd-Jones DM, Hong Y, Labarthe D, Mozaffarian D, Appel LJ, Van Horn L, et al. Defining and setting national goals for cardiovascular health promotion and disease reduction. Circulation. 2010;121(4):586-613.

21

APPENDICES A: Patient’s information sheet and consent

APPENDIX A.1 English version

INFORMATION SHEET

PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM

(for adult subjects and interventional studies)

1. Title of study: Influence Of Stroke Riskometer© In Making Lifestyle Changes Among Urban Dwelling Stroke Caregivers: A Pilot Study.

2. Name of investigator and institution: Dr Radhiyah Hussin, Department of Family Medicine, University Kebangsaan Malaysia.

3. Name of sponsor: None

4. Introduction:

You are invited to participate in a research study because you have the risk to develop stroke since you are related to a family member who had a stroke. Stroke is a condition which occurs when there is a blood clot which blocks the blood supply to the brain or can occur as a result of bursting brain arteries. Stroke can affect the victim in many ways namely; sudden paralysis of one side of body, trouble speaking and seeing, and trouble with memory. Stroke patients usually need help in taking care of themselves. Person who takes care of their daily needs are called caregiver.

You qualify for this research because you are a stroke caregiver. We would like to include you in our study to assess how does a new mobile health application that calculate your risk of getting stroke will affect your lifestyle towards healthier choice after 3 months in the study. The details of the research trial are described in this document. It is important that you understand why the research is being done and what it will involve. Please take your time to read through and consider this information carefully before you decide if you are willing to participate.

Ask the study staff if anything is unclear or if you like more information. After you are properly satisfied that you understand this study, and that you wish to participate, you must sign this informed consent form. To participate in this study, you may be required to provide your doctor with information on your health history.

Your participation in this study is voluntary. You do not have to be in this study if you do not want to. You may also refuse to answer any questions you do not want to answer. If you volunteer to be in this study, you may withdraw from it at any time. If you withdraw, any data collected from you up to your withdrawal will still be used for the study. Your refusal to

22

ID NO:

participate or withdrawal will not affect any medical or health benefits to which you are otherwise entitled.

This study has been approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia.

5. What is the purpose of the study?

The purpose of this study is to determine if Stroke Riskometer Application will help to influence you to make the necessary lifestyle changes to prevent yourself from getting a stroke.

To assess risk of stroke among stroke caregivers at 5 and 10 years.

A total 80 subjects like you from Klang Valley area will be participating in this study.

The whole study will last about 6 months and your participation will be about 12 weeks. You will be seen by our team 3 times during the whole 3 months and will be contacted through phone to check your progress. The first visit will be during recruitment and assessment, second visit will be at intervention phase and third visit will be at the end of intervention. We will collect information like age, education, income, medical problem, medication and lifestyle habit. We will measure your weight, height, blood pressure and waist circumference. We also will collect information regarding your cholesterol and blood sugar.

6. What kind of study products will I receive?

If you agree to participate in the study, the doctor may need to perform some tests and examinations to determine if you are suitable for the study. If you are deemed suitable, you will be randomly (by chance, like flipping a coin) assigned to one of the treatment groups below. You have equal chance of being assigned to each of the groups. Neither you nor the doctor will know which group you are assigned to but in case of emergencies, this information is available to your doctor.

The study products do not contain porcine, bovine or animal components.

You will be allocated to one of the two types of treatment arms. Group 1(Intervention arm) :

Stroke Riskometer Application as intervention, downloaded to your smartphone for free. There are 20 questions that can be answered within 2 minutes using recall method. Your percentage of getting stroke in 5 and 10 years will be calculated and shown to you. We will be monitoring your risk factors in 3 months and look whether you are able to change your lifestyle towards healthier choice after knowing your risk of getting stroke. You will be able to use the application and monitor yourself for the next 3 months.

23

Group 2 ( Control arm) : If you are allocated to this arm you will receive standard assessment using StrokeRiskometer application and calculate your risk of getting stroke but you will not have access to the application.

7. What will happen if I decide to take part?

a) At the first visit an interview session will be conducted by researcher to assess your background socio-economic data, caregiving status and any medical or mental illness. There will be an assessment for your lifestyle such as diet, physical activity, smoking, alcohol intake.

b) During the first assessment, we are going to measure your weight, height, blood pressure and sugar profile. It will be performed by a trained health care provider.

c) Upon entering the study, you will be taught on how to download the application and how to use it.

d) After 12 weeks we are going to assess your risk of getting stroke and physical examination again and compare with previous data.

e) There will be blood taking to check your cholesterol and blood sugar during first visit only.

f) During the trial if we found out any medical issues that need to be addressed and treated we are going to refer to the primary team

8. When will I receive the trial product and how should it be kept?

You will be given access to the Stroke Riskometer App to use throughout the period of the study. You must not use the app to enter anyone else’s information other than your own during the study. The study staff will instruct you on how the product must be handled.

9. What are my responsibilities when taking part in this study?

It is important that you answer all of the questions asked by the study staff honestly and completely. It is very important that your study doctor be informed immediately if you experience any changes to your health during your participation in the study.

10. What kind of treatment will I receive after my participation in the trial?

The study product will be given to you at the end of your participation in the study. Whether you complete the study or withdraw early, your doctor will discuss the best alternatives for your future treatment with you.

11. What are the potential risks and side effects of being in this study?

There are no known potential risks or side effects while being in this study in both intervention and control group.

24

12. What are the benefits of being in this study?

There may or may not be any benefits to you. Information obtained from this study will help improve the treatment or management of other participants with the same disease or condition. The Stroke Riskometer application can be used by you to monitor your progress to reduce your own risk for developing stroke, and guide you to make healthy lifestyle choices.

13. What are my alternatives if I do not participate in this study?

You do not have to participate in this study to get treatment for your disease or condition. The study doctor will discuss in more details the benefits and risks of those treatments with you.

14. Who is funding the research?

This study is self-sponsored. All other drugs and procedures that are not required by the study but are part of your routine medical care will have to be paid by you or your insurance.

15. Will my medical information be kept private?

All your information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. When publishing or presenting the study results, your identity will not be revealed without your expressed consent. Individuals involved in this study and in your medical care, qualified monitors and auditors, the sponsor or its affiliates and governmental or regulatory authorities may inspect and copy your medical records, where appropriate and necessary.

Data from the study will be archived and may be transmitted outside the country for the purpose of analysis, but your identity will not be revealed at any time.

16. Who should I call if I have questions?

If you have any questions about the study or if you think you have a study related injury and you want information about treatment, please contact the study doctor,

Dr. Radhiyah binti Hussin at telephone number 012 3258192 or

Associate Professor Dr Aznida Firzah Abdul Aziz (Tel: 03 91456117)

25

INFORMED CONSENT FORM

Title of Study: Influence of Stroke Riskometer in making lifestyle changes among urban dwelling stroke caregivers; a pilot study.

By signing below I confirm the following:

I have been given oral and written information for the above study and have read and understood the information given.

I have had sufficient time to consider participation in the study and have had the opportunity to ask questions and all my questions have been answered satisfactorily.

I understand that my participation is voluntary and I can at any time free withdraw from the study without giving a reason and this will in no way affect my future treatment. I am not taking part in any other research study at this time. I understand the risks and benefits, and I freely give my informed consent to participate under the conditions stated. I understand that I must follow the study doctor’s (investigator’s) instructions related to my participation in the study.

I understand that study staff, qualified monitors and auditors, the sponsor or its affiliates, and governmental or regulatory authorities, have direct access to my medical record in order to make sure that the study is conducted correctly and the data are recorded correctly. All personal details will be treated as STRICTLY CONFIDENTIAL

I will receive a copy of this subject information/informed consent form signed and dated to bring home.

I agree/disagree* for my family doctor to be informed of my participation in this study.

Subject:

Signature: I/C number:

Name: Date:

Investigator conducting informed consent:

Signature: I/C number:

26

Name: Date:

Impartial witness: (Required if subject is illiterate and contents of participant information sheet is orally communicated to subject)

Signature: I/C number:

Name: Date:

27

APPENDIX A.2 Malay version

RISALAH MAKLUMAT PESERTA DAN

BORANG PERSETUJUAN atau KEIZINAN PESERTA

(untuk subjek dewasa dan penyelidikan intervensi)

.

1. Tajuk penyelidikan: Pengaruh Strok Riskometer dalam melakukan perubahan gaya hidup di kalangan penjaga pesakit strok di kawasan bandar; kajian perintis.

2. Nama Institusi and Nama Penyelidik: Dr. Radhiyah Binti Hussin, Jabatan Perubatan Keluarga, Pusat Perubatan Universiti Kebangsaan Malaysia, Cheras.

3. Nama Penaja: Tiada4. Pengenalan:

Anda telah dijemput untuk menyertai penyelidikan ini kerana anda mempunyai risiko untuk mendapat strok atau angina ahmar memandangkan anda mempunya ahli keluarga yang menghidap strok. Strok adalah serangan otak dan terjadi apabila bekalan darah ke otak terganggu. Saluran darah ke otak boleh terganggu sama ada kerana tersumbat atau berlakunya pembuluh darah yang pecah. Apabila bekalan darah terhenti sel-sel otak akan mati dan menyebabkan pesakit strok mengalami masalah lemah anggota tubuh badan secara serta merta, kesukaran untuk bertutur atau melihat dengan jelas dan juga ingatan terjejas. Pesakit strok selalunya memerlukan bantuan dalam mengendalikan aktiviti kehidupan seharian. Orang yang membantu melancarkan kehidupan seharian pesakit strok adalah dipanggil penjaga. Anda layak untuk menyertai penyelidikan ini kerana anda adalah seorang penjaga pesakit strok. Kami ingin menilai sejauh manakah anda akan mengubah gaya hidup anda ke arah yang lebih sihat setelah anda mengetahui risiko anda untuk mendapat serangan strok melalui satu aplikasi mudah alih yang dipanggil Riskometer Strok.. Kajian ini akan diadakan selama 3 bulan sahaja.

Risalah ini menjelaskan hal-hal berkenaan penyelidikan tersebut dengan lebih mendalam dan terperinci. Amat penting anda memahami mengapa penyelidikan ini dilakukan dan apa yang dilakukan dalam penyelidikan ini. Sila ambil masa yang secukupnya untuk membaca dan mempertimbangkan dengan teliti penerangan yang diberi sebelum anda bersetuju untuk menyertai penyelidikan ini. Jika ada sebarang kemusykilan ataupun maklumat lanjut yang anda ingin tahu, anda boleh bertanya dengan mana-mana kakitangan yang terlibat dalam penyelidikan ini. Setelah anda berpuas hati bahawa anda memahami penyelidikan ini, dan anda berminat untuk turut serta, anda dikehendaki untuk menandatangani Borang Persetujuan atau Keizinan Peserta, pada muka surat akhir risalah ini. Untuk menyertai penyelidikan ini, anda perlu memberi doktor anda maklumat sejarah

28

NO ID:

kesihatan ataupun penyakit anda yang lalu; jika anda tidak berterus terang anda mungkin boleh menimbulkan masalah pada diri anda di kemudian hari.

Penyertaan anda dalam penyelidikan ini adalah secara sukarela. Anda tidak perlu menyertai penyelidikan ini jika anda tidak mahu. Anda juga mempunyai hak untuk tidak menjawab mana-mana soalan yang anda tidak mahu jawab. Anda juga boleh menarik diri daripada penyelidikan ini pada bila-bila masa sahaja. Jika anda menarik diri, segala maklumat yang telah diperolehi sebelum anda menarik diri tetap akan digunakan dalam penyelidikan ini. Jika anda tidak mahu menyertai ataupun menarik diri dari penyelidikan ini, tindakan anda tidak akan menjejaskan segala hak dan keistimewaan perubatan kesihatan yang selayaknya anda terima.

Penyelidikan ini telah mendapat kelulusan Jawatankuasa Etika dan Penyelidikan Perubatan, Kementerian Kesihatan Malaysia.

5. Apakah tujuan penyelidikan ini dilakukan?

Tujuan kajian ini adalah untuk menentukan kemungkinan Applikasi Strok Riskometer dalam mempengaruhi perubahan gaya hidup di kalangan penjaga pesakit strok.

Untuk menilai risiko strok di kalangan penjaga strok dalm tempoh 5 dan 10 tahun.

Kajian ini adalah perlu kerana sehingga kini, tidak ada kajian mengenai pencegahan strok di kalangan penjaga pesakit strok menggunakan mana-mana aplikasi mudah alih yang pernah diusahakan sama ada di peringkat global atau tempatan, khususnya menggunakan Aplikasi Strok Riskometer. Oleh itu, kajian ini bertujuan terutamanya untuk mengumpul peratusan orang yang sudah tahu risiko mereka untuk mendapat strok dan apakah tindakan terhadapnya. Keputusan kajian ini boleh membimbing kita sebagai doktor perubatan keluarga untuk mencegah bukan sahaja strok tetapi penyakit tidak berjangkit yang lain.

Sejumlah 80 peserta seperti anda dianggarkan akan mengambil bahagian . Penyelidikan ini akan berlangsung selama 6 bulan dan tempoh pembabitan anda dianggarkan selama 12 minggu. Sepanjang tempoh 3 bulan tersebut anda akan dinilai dan dilihat oleh pihak kami sebanyak 3 kali. Pihak kami juga akan menghubungi pihak anda melalui telefon untuk memantau kemajuan anda. Lawatan yang pertama adalah semasa proses penyaringan dan pengambilan di mana kami akan mengambil maklumat peribadi antaranya umur, pendidikan, pekerjaan, jumlah pendapatan bulanan, masalah kesihatan lepas dan sekarang, ubatan yang diambil dan gaya hidup anda. Lawatan kedua adalah ketika dalam proses susulan penyelidikan dan terakhir adalah di hujung bulan ke 3 di akhir proses penyelidikan. Kami juga akan mengambil ukuran tinggi, berat, tekanan darah dan ukuran ukur lilit perut serta disusuli dengan mengambil darah untuk mengetahui paras kolesterol and gula dalam badan.

29

6. Apakah produk atau prosedur penyelidikan yang akan saya terima?

Sekiranya anda bersetuju untuk menyertai penyelidikan ini, doktor mungkin perlu menjalankan beberapa ujian dan pemeriksaan terhadap diri anda bagi menentukan samada anda sesuai untuk menyertai penyelidikan ini. Sekiranya anda didapati sesuai, anda akan ditentukan secara rawak (secara kebetulan, seperti melambung duit syiling) kepada salah satu kumpulan rawatan yang dinyatakan di bawah. Peluang untuk anda dimasukkan ke mana-mana kumpulan rawatan adalah sama. Anda dan doktor anda tidak akan mengetahui kumpulan rawatan yang mana yang telah ditentukan, tetapi jika berlaku kecemasan, maklumat mengenai kumpulan rawatan ini masih boleh diperolehi oleh doktor anda.

Produk penyelidikan ini tidak mengandungi sebarang unsur-unsur yang berkaitan dengan khinzir, lembu atau pun produk yang berasaskan haiwan.

Anda akan ditempatkan di dalam salah satu kumpulan :

1. Kumpulan 1 ( Kumpulan intervensi) : Aplikasi Strok Riskometer sebagai intervensi, akan dimuat turun ke telefon pintar anda. Terdapat 20 soalan yang boleh dijawab dalam masa 2 minit menggunakan kaedah mengingat kembali. Peratusan mendapat strok pada 5 dan 10 tahun akan datang akan dikira. Faktor – faktor yang menyebabkan anda berisiko mendapat strok akan dipantau oleh kami dan dalam masa 3 bulan kami akan membuat rawatan susulan untuk melihat perubahan dalam gaya hidup anda. Anda juga dapat menggunakan aplikasi tersebut di rumah dan di mana- mana sahaja kerana aplikasi tersebut akan di muat turun secara percuma.

2. Kumpulan 2 (Kumpulan kawalan) : Kumpulan kawalan di mana anda akan dinilai oleh penyelidik berkenaan risiko mendapat strok menggunakan Aplikasi Strok Riskometer tetapi ia tidak akan dimuat turun dalam telefon pintar anda. Anda akan dinilai dalam 3 bulan untuk melihat perubahan gaya hidup anda.

7. Apakah yang terjadi sekiranya saya bersetuju untuk menyertai penyelidikan ini?

a) Pada lawatan yang pertama, sesi temuduga akan dijalankan oleh pengkaji untuk menilai latar belakang sosio-ekonomi, status penjaga pesakit strok, masalah kesihatan lampau dan terkini samada masalah perubatan atau mental. Akan ada penilaian untuk gaya hidup anda seperti pemakanan, aktiviti fizikal, merokok, pengambilan alkohol.b) Semasa penilaian pertama, kita akan mengukur berat badan, ketinggian, tekanan darah anda, profil gula dan kolesterol anda. Ia akan dilakukan oleh staf kesihatan yang terlatih.c) Apabila menyertai kajian ini, anda akan diajar bagaimana untuk memuat turun aplikasi dan bagaimana untuk menggunakannya.d) Selepas 12 minggu kita akan menilai risiko anda mendapat strok dan pemeriksaan fizikal sekali lagi dan membandingkan dengan data sebelumnya.e) Pengambilan darah akan dilakukan pada pemeriksaan pertama sahaja iaitu untuk melihat paras gula dan tahap kolesterol dalam badan anda.f) Semasa penyelidikan berlangsung jika kita mendapati mana-mana isu-isu perubatan yang perlu ditangani dan dirawat kita akan merujuk kepada pasukan utama dan yang berkenaan.

30

8. Bilakah saya akan menerima produk penyelidikan dan bagaimana cara menyimpannya?

Anda akan diberikan produk penyelidikan setiap kali anda hadir untuk lawatan susulan di sepanjang tempoh rawatan penyelidikan ini. Anda tidak boleh memberi produk tersebut kepada orang lain. Kakitangan penyelidikan ini akan menerangkan kepada anda cara-cara mengendali dan menyimpan produk tersebut.

9. Apakah tanggungjawab saya sewaktu menyertai penyelidikan ini?

Amat penting anda menjawab kesemua soalan yang ditanyakan oleh kakitangan penyelidikan dengan jujur dan lengkap . Jika keadaan atau kesihatan anda berubah sepanjang penyelidikan ini, anda mesti memberitahu doktor penyelidikan anda . Mungkin terdapat ubat-ubat yang tidak boleh anda ambil sepanjang penyertaan anda dalam penyelidikan ini . Doktor akan berbincang dengan anda mengenai ubat-ubat itu . Anda tidak boleh mengambil apa-apa ubat tanpa berbincang terlebih dahulu dengan doktor penyelidikan anda . Anda mesti memberitahu doktor penyelidikan anda dengan segera, sekiranya anda membuat sebarang perubahan dalam rawatan yang sedia ada ( yang sedang anda ambil), walaupun jika anda telah lama mengambil ubat tersebut .

Adalah amat penting untuk memberitahu dengan segera kepada doktor penyelidikan anda jika berlaku sebarang perubahan pada kesihatan anda sepanjang penyertaan anda dalam penyelidikan ini. Demi keselamatan anda, adalah juga amat penting anda mengikut semua arahan yang diberikan oleh doktor penyelidikan anda sepanjang penyelidikan ini dijalankan.

10. Apakah jenis rawatan yang akan saya terima selepas menyertai penyelidikan ini ?

Produk penyelidikan akan diberikan kepada anda selepas tamat tempoh penyelidikan. Sama ada anda mengikuti penyelidikan ini dengan sepenuhnya ataupun menarik diri di pertengahan penyelidikan, doktor anda akan berbincang dengan anda mengenai rawatan alternatif yang terbaik untuk rawatan anda di masa hadapan.

11. Apakah risiko dan kesan-kesan sampingan menyertai penyelidikan ini?

Tiada risiko atau kesan sampingan untuk peserta yang menerima produk penyelidikan. Sila bertanya kepada doktor penyelidikan anda jika anda mahukan lebih banyak maklumat mengenai risiko dan kesan sampingan dalam penyelidikan ini. Dari masa ke semasa, kakitangan penyelidikan akan memberitahu anda berkenaan apa-apa penemuan baru atau perubahan berkaitan produk penyelidikan, yang mungkin boleh menjejaskan kesihatan anda ataupun kerelaan anda untuk terus menyertai penyelidikan ini. Jika keadaan memerlukan, anda mungkin akan diminta memberikan persetujuan/keizinan sekali lagi untuk terus menyertai penyelidikan ini.

12. Apakah manfaatnya saya menyertai kajian ini?

31

Penyelidikan ini mungkin akan mendatangkan manfaat ataupun langsung tiada memberi apa-apa manfaat kepada anda. Segala maklumat yang diperolehi daripada penyelidikan ini akan dapat membantu dalam penambahbaikan kaedah rawatan atau pengurusan peserta lain yang menghidap penyakit atau masalah kesihatan yang sama dengan anda.

13. Apakah rawatan alternatif lain sekiranya saya tidak menyertai penyelidikan ini?

Anda tidak perlu menyertai kajian ini untuk mendapatkan rawatan bagi penyakit atau masalah kesihatan anda.

14. Siapakah yang membiayai penyelidikan ini?

Kajian ini ditaja sepenuhnya oleh pihak kami. Mana-mana prosedur dan rawatan lain yang tidak diperlukan dalam penyelidikan ini tetapi merupakan sebahagian daripada rawatan harian anda, adalah tanggungan anda sendiri ataupun pihak insurans anda. Pihak penaja akan membayar kakitangan penyelidikan kerana meluangkan masa, penggunaan kemudahan kesihatan dan makmal, dan sebagainya kerana melibatkan anda dalam penyelidikan ini.

15. Bolehkah penyelidikan ataupun penyertaan saya ditamatkan lebih awal daripada yang dirancang?

Doktor penyelidikan atau penaja boleh menamatkan penyelidikan ini ataupun menamatkan penyertaan anda dalam penyelidikan ini pada bila-bila masa , jika ia perlu demi keselamatan anda. Jika penyelidikan ini dihentikan terlebih awal, di atas sebab-sebab tertentu, anda akan dimaklumkan dan rawatan yang bakal anda terima selepas itu akan diuruskan. Anda mungkin akan diminta menghadiri satu rawatan susulan terakhir untuk penyelidikan ini.

16. Adakah maklumat perubatan saya akan dirahsiakan ?

Segala maklumat anda yang diperolehi dalam penyelidikan ini akan disimpan dan dikendalikan secara sulit, bersesuaian dengan peraturan-peraturan dan/ atau undang-undang yang berkenaan. Sekiranya hasil penyelidikan ini diterbitkan atau dibentangkan kepada orang ramai, identiti anda tidak akan didedahkan tanpa kebenaran anda terlebih dahulu. Pihak-pihak tertentu seperti individu yang terlibat dalam penyelidikan dan rawatan perubatan anda, juruaudit dan jurupantau yang terlatih, pihak penaja atau pihak gabungannya, pihak berkuasa kerajaan atau undang-undang, boleh memeriksa dan membuat salinan laporan perubatan anda jika berkenaan dan diperlukan.

Segala data yang berkaitan dengan penyelidikan ini akan diarkib dan mungkin dihantar ke luar negara untuk tujuan analisis, tetapi identiti anda tidak akan didedahkan sama sekali pada bila-bila masa. Dengan izin anda, doktor yang merawat keluarga anda akan dimaklumkan mengenai penyertaan anda dalam penyelidikan ini.

17. Siapakah yang perlu saya hubungi sekiranya saya mempunyai sebarang pertanyaan?

32

Anda boleh menghubungi doktor penyelidikan ini Dr. Radhiyah Hussin pada sambungan telefon 012 3258192 sekiranya anda mempunyai sebarang pertanyaan mengenai penyelidikan ini atau jika anda mengesyaki anda mengalami kecederaan yang terhasil daripada penyelidikan ini dan anda mahukan maklumat tentang rawatannya. Jika anda mempunyai sebarang pertanyaan berkaitan dengan hak-hak anda sebagai peserta dalam penyelidikan ini, sila hubungi: Setiausaha,  Jawatankuasa Etika & Penyelidikan Perubatan, Kementerian Kesihatan Malaysia, melalui talian telefon 03-2287 4032.

33

BORANG PERSETUJUAN/ KEIZINAN PESERTA

18. Tajuk Penyelidikan : Pengaruh Riskometer Strok dalam membuat perubahan gaya hidup di kalangan penjaga pesakit strok di kawasan bandar; kajian perintis.

Dengan menandatangani di bawah, saya mengesahkan bahawa :

- Saya telah diberi maklumat tentang penyelidikan di atas secara lisan dan bertulis and saya telah membaca dan memahami segala maklumat yang diberikan dalam risalah ini.

- Saya telah diberikan masa yang secukupnya untuk mempertimbangkan penyertaan saya dalam penyelidikan ini dan telah diberi peluang untuk bertanyakan soalan dan semua persoalan saya telah dijawab dengan sempurna dan memuaskan.

- Saya juga faham bahawa penyertaan saya adalah secara sukarela dan pada bila-bila masa saya bebas menarik diri daripada penyelidikan ini tanpa harus memberi sebarang alasan dan ianya sama sekali tidak akan menjejaskan rawatan perubatan saya pada masa akan datang. Saya tidak mengambil bahagian dalam mana-mana penyelidikan lain pada masa ini. Saya juga memahami tentang risiko dan manfaat penyelidikan ini dan saya secara sukarela memberi persetujuan untuk menyertai penyelidikan ini di bawah syarat-syarat yang telah dinyatakan di atas. Saya faham saya harus mematuhi nasihat dan arahan yang berkaitan dengan penyertaan saya dalam penyelidikan ini daripada doktor penyelidikan (penyelidik) .

- Saya faham bahawa kakitangan penyelidikan, pemantau dan juruaudit terlatih , pihak penaja atau gabungannya, dan pihak berkuasa kerajaan atau undang-undang, mempunyai akses langsung dan boleh menyemak laporan perubatan saya bagi memastikan penyelidikan ini dijalankan dengan betul dan data direkodkan dengan betul. Segala maklumat dan data peribadi akan dianggap sebagai SULIT.

- Saya akan menerima satu salinan ‘Risalah Maklumat Peserta dan Borang Persetujuan atau Keizinan Peserta’ yang telah lengkap dengan tarikh dan tandatangan untuk dibawa pulang ke rumah.

- Saya bersetuju/ tidak bersetuju* untuk doktor yang merawat keluarga saya diberitahu tentang penyertaan saya dalam penyelidikan ini.

Subjek : Tandatangan: Nombor

K/P:

Nama: Tarikh :

34

Penyelidik yang mengendalikan proses menandatangani borang keizinan:

Tandatangan: Nombor K/P:

Nama: Tarikh :

Saksi tidak-berpihak/adil:

Tandatangan: Nombor K/P:

Nama: Tarikh :

35

APPENDIX B

PART 1: DATA COLLECTION FORM

INFLUENCE OF STROKE RISKOMETER ON MAKING LIFESTYLE CHANGES AMONG URBAN DWELLER STROKE CAREGIVERS: A PILOT STUDY.

PART 1

SECTION A: PERSONAL INFORMATION

1. RESEARCH ID : _____________________________________________________

2. DATE OF BIRTH : ___/ ___/ ___3. GENDER : ( ) Male ( ) Female 4. ETHNICITY : ( ) Malay ( ) Chinese ( ) Indian

( ) Other, please specifiy : 5. NATIONALITY : ( ) Malaysian ( ) Non Malaysian ( ) Permanent

Resident6. ADDRESS : _____________________________________________________7. EDUCATION : ( ) Primary ( )Secondary ( ) Tertiary8. OCCUPATION : ( ) Unemployed ( ) Part time, please specify:

( ) Full time, please specifiy: 9. MARITAL STATUS: ( ) Single ( ) Married ( ) Widowed ( ) Divorced10. FAMILY INCOME PER MONTH (RINGGIT MALAYSIA):

: ( ) < RM1000 ( ) RM1000 – RM2000 ( ) RM2000 - RM3000 ( ) RM3000 – RM5000 ( ) >RM 5000

11. FAMILY HISTORY OF STROKE OR HEART ATTACK:

( ) Yes ( ) No

IF YES, STATE RELATION: ___________________

SECTION B: CAREGIVING STATUS

1. Are you currently providing care on an ongoing basis to a person with a chronic illness or disability?IF YES;A. Do you live with this person? ( ) Yes ( ) NoB. How is this person related to you?( ) Parents ( ) Spouse

( ) Siblings ( ) Friend

( ) Distant relative ( ) other:

C. How many hours per week do you spend providing care for him or her?

36

( ) < 6 hours per day( ) 6 – 12 hours per day( ) >12 hours per day

D. Are you getting any payment for providing care for this person? ( ) Yes ( ) No

SECTION C: SMARTPHONE OWNER

1. Do you own a smartphone: ( ) Yes ( ) No

2. Do you know how to use it: ( ) Yes ( ) No

3. Do you have an access to Internet connection on your smartphone: ( ) Yes ( ) No

4. Do you have any experience using health application on mobile phone: ( ) Yes( ) No

5. How frequent do you use your smartphone every day?

( ) 1 – 2 hours

( ) 2 – 3 hours

( ) 3 – 4 hours

( ) more than 4 hours

6. How often do you use non-call features (eg, apps, camera, Internet, multimedia)

( ) often

( ) very often

( ) rarely

SECTION D: MEDICAL HISTORY

1. Have you ever been told by any health care provider that you have: ( ) Diabetes( ) Hypertension( ) Heart disease ( ) Dyslipidaemia( ) Stroke( ) Valvular heart diseaseIf yes since when: …………………..

a. Are you on any regular medication: i. If yes please specify: How will you verify this information?

_______________________________________b. Are you under any follow up for medical problem?

37

i. ( ) Noii. ( ) Yes, at a. PPUKM b. Government

polyclinics c. Government hospital d. Private centrec. Do you always take your medication at the appropriate time? ( ) Yes ( ) No d. Do you ever miss your appointment? ( ) Yes ( ) No

2. Last menstrual period (female participant) : / / /

38

PART 2: Life’s Simple 7 (to be filled by researcher)

Life’s Simple 7

Table 1.Definitions of Ideal, Intermediate, and Poor for Each Life's Simple 7 Health Factor

(Score: 2 points = Ideal; 1 point = Intermediate; 0 points = poor quality)Total score 10-14 (optimal) 5-9 (average) 0-4 (inadequate)

Health Factor

Ideal Intermediate Poor

Cigarette smoking

Never smoker or former smoker and quit >12 months ago

Former smoker and quit ≤12 months ago Current smoker

Body mass index <25 kg/m2 25 to <30 kg/m2 ≥30 kg/m2

Physical activity ≥150 minutes/week 1 to 149 minutes/week None

Healthy diet score 4 to 5 components 2 to 3 components 0 to 1 components

Total cholesterol

<5.18 mmol/L (not treated)

5.18-6.18 mmol/L or treated to goal ≥6.21 mmol/L

Blood pressure

SBP <120 mm Hg and DBP <80 mm Hg (not treated)

SBP 120 to 139 mm Hg or DBP 80 to 89 mm Hg or treated to goal

SBP ≥140 mm Hg or DBP ≥90 mm Hg

Fasting blood glucose

<5.55 mmol/L (not treated)

5.55 to 6.94 mmol/L or treated to goal ≥6.99 mmol/L

39

Table 2.Criteria for Scoring the Life's Simple 7 Healthy Diet

Individual Component of the Healthy Diet Score

Meets Criteria (1 Point)

Does Not Meet Criteria (0 Points)

Food Items

Dietary supplementation

Fruits and vegetables ≥4.5 cups/day <4.5 cups/day

Fresh apples or pears; oranges; peaches, apricots or plums; bananas; other fruits; string beans or green beans; broccoli; cabbage, cauliflower, brussels sprouts; carrots; corn; spinach, collards, or other greens; peas or lima beans; dark yellow, winter, squash such as acorn, butternut; sweet potatoes; beans or lentils such as pinto, black eye, baked beans; tomatoes; potatoes

Fish ≥two 85 grams servings/week

<two 85 grams servings/week

Dark meat fish such as salmon, mackerel, swordfish, sardines, bluefish; canned tuna fish; other fish such as cod, perch, catfish

Fiber‐rich whole grains

≥three 28 gram equivalent servings/day (≥1.1 g fiber/10 g carbohydrate)

<three 28 gram equivalent servings/day (<1.1 g fiber/10 g carbohydrate)

Fiber and carbohydrate as calculated using USDA sources for nutritional content of food items

40

Individual Component of the Healthy Diet Score

Meets Criteria (1 Point)

Does Not Meet Criteria (0 Points)

Food Items

Dietary restriction

Sodium <1500 mg/day ≥1500 mg/daySodium as calculated using USDA sources for nutritional content of food items

Sugar‐sweetened beverages

≤450 kcal (36 oz)/week

>450 kcal (36 oz)/week

Regular soft drinks such as Coke, Pepsi, 7‐Up, ginger ale; fruit‐flavored punch or noncarbonated beverages such as lemonade, Kool‐Aid, or Hawaiian Punch

APPENDIX C: Permission to use Stroke Riskometer Application and Life’s Simple 7

41

Product specification and marketing guideline of Life’s Simple 7 for health care providers and consumers

42

43

44

45

46

47