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A Randomized Trial of a Self-Regulation Intervention for Women With Asthma^*

^* From the Center for Managing Chronic Disease (Drs. Clark and Gong), and the Department of Biostatistics (Mr. Wang), School of Public Health, and the Department of Obstetrics and Gynecology (Dr. Johnson), School of Medicine, University of Michigan, Ann Arbor, MI; the Department of Biostatistics (Dr. Lin), School of Public Health, Harvard University, Cambridge, MA; and Shriners Hospitals for Children (Dr. Bria), Tampa, FL.

Correspondence to: Noreen Clark, PhD, University of Michigan, School of Public Health, 109 S Observatory, Ann Arbor, MI 48109; e-mail: nmclark{at}umich.edu

Abstract

Background: Women with asthma have greater mortality and morbidity than men in the United States. To date, there has been no rigorous evaluation of an intervention focused on the particular problems in asthma management faced by women. This study was a randomized clinical trial of a self-regulation, telephone counseling intervention emphasizing women’s concerns, and sex and gender role factors in their management of asthma.

Methods: A total of 808 women with diagnosed asthma were randomly assigned to the intervention group or a usual-care control group, including conventional asthma education. Interviews and medical record data were collected to assess psychosocial factors, and the behavioral factors of functioning, quality of life, symptoms, and health-care use at baseline and the subsequent 1 year. Generalized estimating equations, identity link, logit link, and log link were employed to analyze the data.

Results: Compared to control subjects, the women receiving treatment had greater annual reductions in the average number of nights with asthma symptoms (p = 0.04), days of missed work/school (p = 0.03), emergency department visits (p = 0.04), unscheduled office visits (p = 0.01), and scheduled office visits (p = 0.04). They had greater recognition of asthma symptoms during the menstrual cycle (p = 0.0003), had decreased asthma symptoms with sexual activity (p = 0.008), and had greater improvement in quality of life (p = 0.0005), self-regulation (p = 0.03), and self-confidence to manage asthma (p = 0.001).

Conclusion: The intervention improved women’s clinical status, functioning, quality of life, and health-care use. A program with a focus on asthma management problems particular to women can significantly assist female asthma patients.

Key Words: asthma • chronic conditions • management by patients • outcomes • women’s health