The Effect of Self-regulatory Education on Women With Asthma

NCT ID: NCT00217802

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2007-02-28

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.

Detailed Description

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

six-session telephone counseling program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

, mental illness or terminal illness) are excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Noreen Clark

Role:

University of Michigan

Other Identifiers

R01HL060884

Identifier Type: NIH

Identifier Source: secondary_id

View Link

289

Identifier Type: -

Identifier Source: org_study_id