An interventional study of six-session telephone counseling program in Asthma, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
Browse Asthma studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
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The study participants are a noninstitutionalized ambulatory sample of women who are willing to participate in the project and meet the following criteria:
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.
No study locations are listed for this record.
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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National Heart, Lung, and Blood Institute (NHLBI)