The Effect of Self-regulatory Education on Women With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00217802
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 29, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
The project evaluates an innovative educational intervention using telephone counseling based on self-regulation theory designed to address a problem heretofore overlooked in asthma self-management education: the unique needs of adult female patients.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: six-session telephone counseling program Not Applicable

Detailed Description:


More than half of the adults with asthma in the US are female. Prevalence of asthma in women appears to be increasing, and morbidity and mortality rates for this group are significantly higher than rates for men. Recent studies point to unique features in women's management of asthma potentially attributable to gender. These include, for example, factors associated with hormonal cycles, (e.g. menses, pregnancy, menopause) and social roles (e.g. household tasks exposing one to environmental triggers, caregiving to children and relatives interfering with asthma management etc.) To date, no rigorously evaluated intervention expressly designed for women with asthma has been reported in the literature.


This study is to assess the effectiveness of a gender-specific telephone counseling, self-regulation intervention for women with asthma. To test our hypothesis we employed a randomized controlled design utilizing an intervention group and a control group. The primary outcomes are gender-related asthma management problems, health care utilization, days having symptoms, self-regulation level, management skill, and quality of life. We measure at three time points: baseline before randomization; follow-up I, one year subsequent to randomization; and follow-up II, one year subsequent to follow-up.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : March 2000
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

The study participants are a noninstitutionalized ambulatory sample of women who are willing to participate in the project and meet the following criteria:

  1. 18 years of age or older,
  2. a diagnosis of asthma,
  3. presence of active symptoms,
  4. enrolled as a patient in one of the University of Michigan Medical Center asthma-related clinics,
  5. listed as having received face-to-face instructions by clinic personnel on peak flow monitoring and proper use of medicine and delivery devices, and
  6. not pregnant.

Women who are found to have extenuating circumstances that would prevent them from fully benefiting from the program (e.g., mental illness or terminal illness) are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00217802

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Noreen Clark University of Michigan Identifier: NCT00217802     History of Changes
Other Study ID Numbers: 289
R01HL060884 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: January 2008

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases