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
  Purpose

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.


Condition Intervention
Asthma
Behavioral: six-session telephone counseling program

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: March 2000
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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., mental illness or terminal illness) are excluded.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217802

Sponsors and Collaborators
Investigators
Investigator: Noreen Clark University of Michigan Ann Arbor
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00217802     History of Changes
Other Study ID Numbers: 289
Study First Received: September 19, 2005
Last Updated: January 18, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014