University of Michigan School of Public Health
Ann Arbor, Michigan, 48109-2029, United States
NCT Number: NCT01117805
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.
Looking for future studies?
Notify Me18 year–100 year
Female
Interventional
Not applicable
Ann Arbor, Michigan, 48109-2029, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The study participants will be a non-institutionalized ambulatory sample of women who are willing to participate in the project and meet the following criteria:
Exclusion criteria
self-regulation telephone counseling program for African American women with asthma
Other names: Women Breathe Free
Time frame: 12months prior to baseline interview
We will collect health care utilization data related to asthma. Women in the study will be asked during their baseline telephone interview to provide information regarding the frequency of Emergency Department visits related to asthma during the year prior to the baseline interview. Second, women's CareWeb and billing records will be reviewed for asthma related ED visits during this time period.
Time frame: Interval between baseline interview and 12 month interview
We will collect health care utilization data related to asthma. Women in the study will be asked during the SECOND TELEPHONE INTERVIEW to provide information regarding the frequency of Emergency Department visits related to asthma for their year between their baseline and 12month interview. In addition, we will review their CareWeb and billing record data for that time period to see if there are any asthma related Emergency Department visits.
Time frame: Interval between 12 month and 24 month telephone interview
We will collect health care utilization data related to asthma. Women in the study will be asked during the THIRD TELEPHONE INTERVIEW to provide information regarding the frequency of Emergency Department visits related to asthma for their year between their 12 month and 24 month telephone interview. In addition, we will review their CareWeb and billing record data for that time period to see if there are any asthma related Emergency Department visits.
Time frame: Year prior to baseline interview
Women participating in the study will be asked during their BASELINE telephone interview to provide information on hospitalizations related to asthma for the year prior to their baseline interview.In addition, women's Careweb and billing records will be reviewed for hospitalizations for the above mentioned time period.
Time frame: interval between baseline and 12 month interview
Women participating in the study will be asked during each of their telephone interviews to provide information on hospitalizations related to asthma. During their SECOND TELEPHONE INTERVIEW they will be asked to provide this information for the year between when their baseline interview was conducted and when we are administering the 12 month interview. In addition, women's Careweb and billing records will be reviewed for hospitalizations for the above mentioned time period.
Time frame: interval between 12month and 24 month telephone interview
Women participating in the study will be asked during each of their telephone interviews to provide information on hospitalizations related to asthma. During their THIRD TELEPHONE INTERVIEW women will be asked to report the number of hospitalizations related to asthma that occurred for the year between when we conducted their 12 month interview and when we are administering the 24month interview. In addition, women's Careweb and billing records will be reviewed for hospitalizations for the above mentioned time period.
University of Michigan
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT07394127
Asthma, Asthma Chronic
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Turkey (Türkiye)
View Trial DetailsNCT01678222
Allergic Inflammation, Asthma
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT03937804
Asthma, Bronchial Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial Details