Effect of Self-Regulatory Education on Women with Asthma

July 12, 2003

Outlines

The research project

The intervention program

Baseline findings

Investigators

Noreen M. Clark, PhDPrincipal InvestigatorDean and Marshall H. Becker Professorof Health Behavior and HealthEducation, School of Public Health.

Timothy R. B. Johnson, MDCo-InvestigatorBates Professor, Diseases of Women &Children, Chair, Department of Obstetrics andGynecology, University of Michigan

William F. Bria, MDCo-Principal InvestigatorAssistant Professor, Pulmonary &Critical Care Medicine, University ofMichigan

Xihong Lin, PhDCo-InvestigatorProfessor, Biostatistics

Research Team

PI (Co-PI & Co-investigators) Oversees all aspects of the study

Project director-secretaryDaily operation

Data collection team5-6 graduate studentsRecruiting & interview

Intervention team2-3 health educators

Deliver program

Data analystManager/Analyst

Database / analysis

Background - Prevalence

Five million women are currently diagnosed with asthma (Crespo, 1997)

Asthma prevalence rate for women increased 82% compared to 29% for men (1982-1992, CDC)

Asthma mortality rate increased 59% for women compared to 34% for men (1982-1992, CDC)

0.00%

20.00%

40.00%

60.00%

80.00%

100.00%

Pre

vale

nce

Mo

rtal

ity

Women

Men

Background – Morbidity & Hospitalization

Hospital admission for asthma: Women 2 times more than men. (Skobeloff, 1996)

More symptoms and worse quality of life reported by female asthma patients compared to male patients. (Osborn, 1998)

Menstrual-Linked Asthma

30-40% of women with asthma report symptoms worsening prior to or during menses. Significantly reduced Peak Flow Rates, more medication and health care use were found during this period of menstrual cycle. (Agarwal, 1997; Eliasson, 1986)

Disease is more severe in women with menstrual-linked asthma.

Use of oral contraceptive medication may reduce symptom variability in women with menstrual-linked asthma.(Tan, 1997)

Factors Related to Women’s Traditional Tasks in Household

Cooking-related irritants and triggers include gas, wood smoke, cooking oils, food preservatives, monosodium glutamate, coloring agents.

Cleaning-related indoor allergens include house dust, domestic house-dust mites, fungi, molds, yeasts, sprays, cleaning products, and scented products.

The research project

Purpose

To evaluate an innovative education program based on self-regulation theory designed to address the unique needs of adult female patients with asthma.

Specific Hypotheses

Decreased gender-related asthma management problems

Decreased symptoms

Reduced health care use

Reduced work absence

Improved quality of life

Study Design

A randomized controlled design utilizing an intervention group and a control group.

Recruitment criteria 18 years of age or

older

A diagnosis of asthma

A patient in one of the clinics at University of Michigan Health System

IRBMED Approved Recruitment Procedures

A list of female patients diagnosed with asthma is provide by the UM Health System Data Warehouse

An individual Invitation letter signed by investigators and personal physician is mailed to the potential participant

A phone call follows

Consent forms are sent for signatures

Data collection

Baseline Follow-up I: 12 months subsequent

to baseline (approximately 6 months subsequent to program completion)

Follow-up II: 12 months subsequent to there after.

Three time points:

Randomization After baseline data collection,

participants are randomly assigned to either the intervention or the control group. Women in the intervention group receive the “Women Breathe Free” telephone counseling program. Women in the control group will receive the program after it is evidenced to be effective and requested by the woman.

WOMENWOMENBREATHEBREATHE

FREEFREE

Components of the intervention

Theoretical Framework-Social cognitive

theory (Bandura, 1986), and the principles of

self-regulation (Clark & Zimmerman, 1990,

Clark, 1992) applied

Gender-related management problems

addressed

Peak flow meter and diary used

Telephone counseling sessions delivered

Asthma Education Kit

Workbook

Peak Flow Meter

PFM Video

Diary

Our Health Educators

What the Health Educators Do

Introduce a problem solving process. Guide through a period of self-

observation using PFM & Diary. Encourage to discuss questions and

observations with physicians to enhance the patient-physician partnership in asthma management.

Self-regulatory problem solving steps

First step: select a problem

I have a problem with my diagnosis of asthma: Do I really have asthma?

I feel chest tightness and/or may wheeze whenever I cook, vacuum, or dust.

My asthma symptoms get worse when I have premenstrual syndrome.

Smoke may trigger my symptoms, and I live with someone who smokes. I’m afraid to tell them because I don’t want to hurt their feelings.

Second step:

Coach the participant to use diary and peak flow meter as observational tools to track related factors. The participant logs peak flow readings, hormonal cycles, symptoms, triggers, other medical conditions, medication use, tasks, activities & events every day for 4-6 weeks.

Women Breathe Free Program

Example – My Asthma Diary

My Name: Jane Doe My Birthday: / / My personal best peak flow reading (PBR) is: Green Zone: no symptoms or above 80% PBR Yellow Zone: some symptoms or 50-80% PBR Red Zone: severe symptoms or below 50% PBR

Day & Date Mon

a.m. 1/8/01 p.m.

Tue

a.m. 1/9/01 p.m.

Wed

a.m. 1/10/01 p.m.

Thur

a.m. 1/11/01 p.m.

Fri

a.m. 1/12/01 p.m.

Sat

a.m. 1/13/01 p.m.

Sun

a.m. 1/14/01 p.m.

Peak flow rates 300310

260300

230220

220240

250270

260250

220280

Nosymptoms

Somesymptoms

Severesymptoms

Menstrual bleeding Oral contraceptivesEstrogen R T (ERT)

SymptomsRunny nose,scratchy throat,heartburn.

Same as yesterdayplus headache. Noheartburn.

Cough, slight chesttightness, throatclearing, yellowmucus from nose,headache, cramps.

Nasal and chestcongestion,wheezing, woke upcoughing in night,breathless, cramps.

Tired, restless,heartburn, cough,wheeze, stuffynose, thick yellowgreen mucus.

Cough, urinaryleakage, chest tight,sinus drainage,headache.

Same as yesterdaybut no headache.

Medicine

Serevent 4puffs/dayFlovent 4puffs/daySingulair 10mg/dayClaritin 10mg/dayPrilosec 20mg/day

Same as Mon plus2 Advil 3 timestoday.

Same as yesterdaybut doubledFlovent. Used 2puffs albuterol 3times today.

Same as yesterday.Switched fromalbuterol puffer tonebulizer; 4treatments.

Same as yesterday.Called Dr., put onZithromax for sinusinfection. NoAdvil.

Same as yesterday.Day 2 of Z-Pak.

Same as yesterday.Day 3 of Z-Pak.

PossibleTriggers

Allergies? Cold?Drank 3 cups ofcoffee and ate spicyfood for dinner.

Time in dampmoldy basement,used Lysol &Tilex.Getting a cold?Period due...

Definite coldsymptoms.Premenstrual. Timein dusty storeroomat work. Feelingmoody & anxious.

Period started. Coldworse. Changedtoner in printer atwork. Cooked andbaked in hotkitchen.

Sinus infection.Stressed, tired. Hadto clean house-- in-laws coming.

Cold, laundry soap,taking the basementstairs a lot. Father-in-law smoking inhouse, mother-in-law’s perfume.

Cold/sinussymptoms, stress,fatigue.

Activities andEvents

Took kids to school& back, worked,cooked, ranerrands, exercised.

Same as yesterdayplus laundry, sweptbasement, cleanedbird cage, walkeddogs.

Kids, work, petcare, cooking,stayed up later thanusual.

Preparing forfamily dinner onSat. Usual tasks athome and work--noexercise

Stayed home fromwork-tried to restbut had to cleanand cook. Napped.

Stripped the beds,did the wash.Hosted dinner forin-laws.

Watched T.V.Rested on thecouch, napped.

Third step:

Identifying self-management asthma goal (short and long term goals)

Long-term goal: to clean the house without wheezing.

Short term goal: to vacuum the house without symptoms

Examples of Goals

Fourth step: Developing my plan

Steps to reaching my short-term goal are:

1. Buy masks & dust proof vacuum bags.

2. Wear mask every time I vacuum.

3. Have someone vacuum for me.

Developing a plan for reaching the goal (lists of barriers and strategies to reach the goal)

Developing my plan:

Barriers Strategies

Did not know where to purchase masks & vacuum cleaner bags

Ask my asthma coach or look at information in workbook under supplies

Forget to wear mask Hang mask on vacuum cleaner handle

Feel someone may not be able to do a good job

Instruct & trust other people can do a good job

Other self-regulatory steps

Exploring a reward

Developing a health-related contract

Preliminary Evaluation

Among a total of 166 program participants, 80% (n=131) completed required 4 diaries, 83% (n=109) completed 8 or more diaries, 87% (n=113) completion with 4 categories, 94% completion of peak flow entry.

I was a reluctant participant with mild asthma but found the program helpful in identifying when to use medication. I am now more likely to use my inhaler than I might have been without the program.

Baseline Findings

Sample demographics (n=439)

Age

8%

17%

24%25%

17%

9%

18-30

31-40

41-50

51-60

61-70

>71

Sample demographics

Annual Household Income

4% 6%

16%

20%

14%

12%

17%

11%<10,000

10,001-20,000

20,001-40,000

40,001-60,000

60,001-80,000

80,000-100,000

>100,000

refusal

Sample demographics

2%

26%

21%30%

21%< High School

High School

2-year College

4-year College

Post Grad

Education Level

Sample demographics

Race/Ethnicity

85%

2%

8%

2%1%

2% Caucasian/White

AfricanAmerican/BlackAsian/Pacific Islander

Hispanic/Latino

Native American

Other

Asthma severity

Percent of Women

Mild intermittent

52.62

Mild persistent

14.35

Moderate persistent

18.45

Severe persistent

14.58

Classified by NAEPP criteria, Guidelines and Diagnosis and Treatment of Asthma, NHLBI, NIH, 1997

Co-Morbidities Reported

Reflux: 72%Reflux

No Reflux

Overweight

Obese

Over Obese

Normal Weight

Over weight (BMI=26-30): 28%,

Obese (BMI 31-35): 30% Over obese (BMI > 35):

9%

Co-Morbidities Reported

Urinary incontinence: 54%

UrinaryIncontinence

No UrinaryIncontinence

Migraines: 34%Migraines

No Migraines

Health care utilization during the past 12 months One fourth of the

women had at least one ED visit.

8% were hospitalized

35% had one or more unscheduled urgent visit to a doctor’s office.

0%5%

10%15%20%25%30%35%

ED V

isit

Hos

pita

lized

Uns

ched

uled

Visi

t

Women

Peak Flow Meter Usage

Almost 80% of the women owned a peak flow meter.

Less than 7% of the women used it every day.

30% used their peak flow meter only when they felt an asthma attack was coming on.

0%10%20%30%40%50%60%70%80%

Ow

ned

Use

d D

aily

Use

d be

fore

asth

ma

atta

ck

Women

Factors Associated with Persistent Disease

1. Low annual household income, a lower level of education, and not working for pay were associated with persistent asthma, whereas, age, marital status, and ethnicity were not.

2. Women with persistent asthma were more likely to have high BMI, maintain a low level of exercise, have lower self-esteem, had more social support compared to women with intermittent disease.

Hormone Related Findings

54% women currently menstruate. Among those:

15% noticed symptoms worsening during the week prior to the period.

Over half of the women reported PMS symptoms. The more severe the asthma symptoms, the more severe the PMS symptoms (r=0.364, p<.0001)

30% women reported they were bothered by symptoms of asthma during sexual activity. The more severe the asthma symptoms, the more bothersome during sexual activity (r=0.361, p<.0001)

Hormonal factors and health care utilization

# ofHospitalizations

# of ED Visits # of UnscheduledDoctor Visits

Est. RRp-

valueEst. RR

p-value

Est. RRp-

value

Currently menstruates 0.374 1.45 0.217 0.096 1.10 0.634 0.156 1.17 0.228

Noticed that asthmasymptoms change duringthe menstrual cycle

1.893 6.64 0.000 0.764 2.14 0.001 0.41 1.51 0.012

Reported PMS 0.125 1.13 0.000 0.038 1.03 0.066 0.069 1.06 0.000

Menstruation and Asthma Health Care Utilization

Urinary incontinence was significantly associated with

older age, not working for pay, ever been pregnant, history of smoking, and a higher body mass index.

more days of daytime and nighttime symptoms and more hospitalizations and clinic visits.

lower self-esteem, social support, and overall quality of life.

Overweight was significantly associated with:

Older age (p=.05), lower level of education (p=.0001), and household income (p=.002), being unmarried (p=.02), and African American (p=.04);

More days of daytime (0=.06) and nighttime symptoms (p=0.08), more hospitalization (p=.0001), ED visit (p=.0029), urgent office visits (p=.008), scheduled office visits (p=.03), and visits to follow-up an asthma attack (p=.009);

Urinary incontinence (p=.0001), migraine headache (p=.03), and reflux (p=.02);

Lower level of quality of life (p.0002) and self-esteem (p=.001)

Limitations

This study sample includes a number of women with high levels of education and income.

The findings reported here are from preliminary analysis.

Thank You!