The Effect of Self-Regulatory Education on Women With Asthma

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00217802
First received: September 19, 2005
Last updated: January 18, 2008
Last verified: January 2008

September 19, 2005
January 18, 2008
March 2000
February 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00217802 on ClinicalTrials.gov Archive Site
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The Effect of Self-Regulatory Education on Women With Asthma
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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.

Interventional
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Allocation: Randomized
Primary Purpose: Treatment
Asthma
Behavioral: six-session telephone counseling program
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2007
February 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00217802
289
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Noreen Clark University of Michigan Ann Arbor
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP