Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01117805
Brief Summary:
The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to use a highly tailored, telephone counseling approach to address both specific cultural factors affecting asthma and the influence of female sex and gender on control.
Detailed Description:
Research and practice efforts in asthma continue to overlook one of the most vulnerable subgroups of Americans, minority women. Women of color, especially African Americans, bear a significantly disproportionate burden of asthma among adults. However, no rigorous trial of an intervention to assist them with their particular challenges can be located. The proposed randomized controlled trial will evaluate an innovative intervention in 420 African American women with asthma. It will be the first to address both specific cultural factors affecting asthma and the influence of female sex and gender on control. It will use a highly tailored, telephone counseling approach designed to foster partnership with the clinician, resolution of specific asthma management problems, and identification of important contributing influences often misunderstood or ignored by women themselves as well as the health care system. It will attend closely to the role of allergy in asthma management as patients in the African American population have been shown to be at greater risk for allergic asthma.
Data will be collected at baseline, 12, and 24 months by telephone interview and from medical records. The hypotheses of the research are that women in the intervention group when compared to the control group will:
* Use emergency department services for asthma less frequently and need urgent care in a physician's office less often;
* Be hospitalized for asthma less frequently.
* Experience fewer symptoms of asthma;
* Have higher levels of asthma-related quality of life
The intervention aims to reduce the burden of asthma as carried by a large subgroup of the adult population. It employs state of the art asthma management strategies and creative means to reach and help patients at high risk of asthma exacerbations and health care use.
Study:
NCT01117805
Study Brief:
Protocol Section:
NCT01117805