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Completed

NCT Number: NCT00217802

The Effect of Self-regulatory Education on Women With Asthma

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.

Completed

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 18 years of age or older,
  • a diagnosis of asthma,
  • presence of active symptoms,
  • enrolled as a patient in one of the University of Michigan Medical Center asthma-related clinics,
  • listed as having received face-to-face instructions by clinic personnel on peak flow monitoring and proper use of medicine and delivery devices, and
  • 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.

Treatment and study plan

six-session telephone counseling program

Behavioral

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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