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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00217802
Study type Interventional
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status Completed
Phase N/A
Start date March 2000
Completion date February 2007

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