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, PhD Timothy R. B. Johnson, MD

Principal Investigator Co-Investigator
Dean and Marshall H. Becker Professor Bates Professor, Diseases of Women &
of Health Behavior and Health Children, Chair, Department of Obstetrics and
Education, School of Public Health. Gynecology, University of Michigan

William F. Bria, MD Xihong Lin, PhD

Co-Principal Investigator Co-Investigator
Assistant Professor, Pulmonary & Professor, Biostatistics
Critical Care Medicine, University of
Michigan
 Research Team

PI (Co-PI & Co-investigators)

Oversees all aspects of the study

Project director-secretary
Daily operation

Data collection team Intervention team Data analyst

5-6 graduate students 2-3 health educators Manager/Analyst
Recruiting & interview Deliver program Database / analysis
Background - Prevalence
100.00%
 Five million women are
currently diagnosed with 80.00%
asthma (Crespo, 1997)
60.00%

 Asthma prevalence rate 40.00%

for women increased 82% Women
compared to 29% for men 20.00% Men
(1982-1992, CDC)
0.00%

Prevalence

Mortality
 Asthma mortality rate
increased 59% for women
compared to 34% for men
(1982-1992, CDC)
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
Three time points:
 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.
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.
 WOMEN
BREATHE
FREE
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 Tue Wed Thur Fri Sat Sun
a.m. 1/8/01 p.m. a.m. 1/9/01 p.m. a.m. 1/10/01 p.m. a.m. 1/11/01 p.m. a.m. 1/12/01 p.m. a.m. 1/13/01 p.m. a.m. 1/14/01 p.m.
Peak flow rates 300 260 230 220 250 260 220
310 300 220 240 270 250 280
No
symptoms

Some
symptoms

Severe
symptoms

Menstrual bleeding    
Oral contraceptives
Estrogen R T (ERT)
Runny nose, Same as yesterday Cough, slight chest Nasal and chest Tired, restless, Cough, urinary Same as yesterday
Symptoms scratchy throat, plus headache. No tightness, throat congestion, heartburn, cough, leakage, chest tight, but no headache.
heartburn. heartburn. clearing, yellow wheezing, woke up wheeze, stuffy sinus drainage,
mucus from nose, coughing in night, nose, thick yellow headache.
headache, cramps. breathless, cramps. green mucus.
Serevent 4puffs/day Same as Mon plus Same as yesterday Same as yesterday. Same as yesterday. Same as yesterday. Same as yesterday.
Flovent 4puffs/day 2 Advil 3 times but doubled Switched from Called Dr., put on Day 2 of Z-Pak. Day 3 of Z-Pak.
Medicine Singulair 10mg/day today. Flovent. Used 2 albuterol puffer to Zithromax for sinus
Claritin 10mg/day puffs albuterol 3 nebulizer; 4 infection. No
Prilosec 20mg/day
times today. treatments. Advil.
Allergies? Cold? Time in damp Definite cold Period started. Cold Sinus infection. Cold, laundry soap, Cold/sinus
Possible Drank 3 cups of moldy basement, symptoms. worse. Changed Stressed, tired. Had taking the basement symptoms, stress,
coffee and ate spicy used Lysol &Tilex. Premenstrual. Time toner in printer at to clean house-- in- stairs a lot. Father- fatigue.
Triggers food for dinner. Getting a cold? in dusty storeroom work. Cooked and laws coming. in-law smoking in
Period due... at work. Feeling baked in hot house, mother-in-
moody & anxious. kitchen. law’s perfume.
Took kids to school Same as yesterday Kids, work, pet Preparing for Stayed home from Stripped the beds, Watched T.V.
Activities and & back, worked, plus laundry, swept care, cooking, family dinner on work-tried to rest did the wash. Rested on the
cooked, ran basement, cleaned stayed up later than Sat. Usual tasks at but had to clean Hosted dinner for couch, napped.
Events errands, exercised. bird cage, walked usual. home and work--no and cook. Napped. in-laws.
dogs. exercise
Third step:

 Identifying self-management asthma

goal (short and long term goals)

Examples of Goals
 Long-term goal: to clean the
house without wheezing.
 Short term goal: to vacuum the
house without symptoms
Fourth step: Developing my plan

 Developing a plan for reaching the

goal (lists of barriers and strategies to
reach the goal)
 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 my plan:
Barriers Strategies

Did not know where to Ask my asthma coach or

purchase masks & vacuum look at information in
cleaner bags workbook under supplies
Forget to wear mask Hang mask on vacuum
cleaner handle
Feel someone may not be Instruct & trust other
able to do a good job 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
9% 8%

17%
17% 18-30
31-40
41-50
51-60
61-70
24%
25% >71
 Sample demographics
Annual Household Income
11% 4%
6%
<10,000
10,001-20,000
16%
17% 20,001-40,000
40,001-60,000
60,001-80,000
80,000-100,000
12%
20% >100,000
refusal
14%
 Sample demographics
Education Level
2%
21%
26% < High School

High School

2-year College

4-year College

30% Post Grad

21%
 Sample demographics
Race/Ethnicity

2% Caucasian/White
85%
1% African
2% American/Black
Asian/Pacific Islander
2%
Hispanic/Latino
8%
Native American
Other
Asthma severity

Percent of
Women
Mild 52.62
intermittent
Classified by NAEPP
Mild 14.35 criteria, Guidelines and
persistent Diagnosis and Treatment
of Asthma, NHLBI, NIH,
Moderate 18.45 1997
persistent
Severe 14.58
persistent
 Co-Morbidities Reported

Reflux
No Reflux
 Reflux: 72%

 Over weight (BMI=26-30): 28%,

 Obese (BMI 31-35): 30%
 Over obese (BMI > 35): 9%
Overweight
Obese
Over Obese
Normal Weight
 Co-Morbidities Reported

Urinary
Incontinence
 Urinary No Urinary
Incontinence

incontinence: 54%

 Migraines: 34% Migraines

No Migraines
Health care utilization during
the past 12 months
 One fourth of the 35 %
30 %
women had at least 25 %
one ED visit. 20 %
15 %
 8% were 10 %
5% W o m en
hospitalized 0%
 35% had one or

ED Visit

Hospitalized

Unscheduled
more unscheduled

Visit
urgent visit to a
doctor’s office.
Peak Flow Meter Usage
 Almost 80% of the 80%
women owned a 70%
60%
peak flow meter. 50%
40%
 Less than 7% of the 30%
20%
women used it 10% W o m en
0%
every day.

Owned

Used Daily

asthma attack
Used before
 30% used their peak
flow meter only
when they felt an
asthma attack was
coming on.
 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
Menstruation and Asthma Health Care Utilization

# of # of ED Visits # of Unscheduled
Hospitalizations Doctor Visits
p- p- p-
Est. RR Est. RR Est. RR
value value value

Currently menstruates 0.374 1.45 0.217 0.096 1.10 0.634 0.156 1.17 0.228

Noticed that asthma

symptoms change during 1.893 6.64 0.000 0.764 2.14 0.001 0.41 1.51 0.012
the menstrual cycle

Reported PMS 0.125 1.13 0.000 0.038 1.03 0.066 0.069 1.06 0.000
 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!