Women of Color and Asthma Control

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Noreen M. Clark, University of Michigan
ClinicalTrials.gov Identifier:
NCT01117805
First received: May 3, 2010
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Telephone counseling intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Women of Color and Asthma Control

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Emergency department visits - 1st time point [ Time Frame: 12months prior to baseline interview ] [ Designated as safety issue: No ]
    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.

  • Emergency Department Visits -2nd time point [ Time Frame: Interval between baseline interview and 12 month interview ] [ Designated as safety issue: No ]
    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.

  • Emergency Department Visits - 3rd time point [ Time Frame: Interval between 12 month and 24 month telephone interview ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Hospitalizations - first time point [ Time Frame: Year prior to baseline interview ] [ Designated as safety issue: No ]
    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.

  • Hospitalizations related to asthma - 2nd time point [ Time Frame: interval between baseline and 12 month interview ] [ Designated as safety issue: No ]
    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.

  • Hospitalizations related to asthma - 3rd time point [ Time Frame: interval between 12month and 24 month telephone interview ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 420
Study Start Date: May 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
Subjects will be randomized to the program intervention which is a female-specific, culturally relevant, self-regulation based telephone counseling intervention designed for African American women with asthma.
Behavioral: Telephone counseling intervention
self-regulation telephone counseling program for African American women with asthma
Other Name: Women Breathe Free
No Intervention: usual care
Usual care at the University of Michigan Health System is based on the guidelines as recommended by the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP-EPR3): Diagnosis and Treatment of Asthma and is coordinated so that all patients receive the same action plan, educational materials and instructions in use of devices.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Self-identify as African-American
  • 18 years of age or older
  • Are listed on the University of Michigan Health System (UMHS) Asthma Patient Registry, a validated, all-payer registry of patients with persistent asthma cared for within the UM Health System
  • Have access to a telephone or cell phone
  • Are not pregnant.. Because the UMHS Asthma Patient Registry is validated, there is minimal risk of diagnostic misclassification. The Registry is created and maintained with a two-step process of identification and validation. UMHS patients with persistent asthma are initially identified through the electronic medical record using National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS) criteria, billing and claims data (when available), and then are validated using documented clinical diagnoses, pulmonary function test (PFT) results, or clinician review.

Exclusion Criteria:

  • Patients with chronic respiratory conditions, including cystic fibrosis and chronic obstructive pulmonary disease (COPD) 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: NCT01117805

Locations
United States, Michigan
University of Michigan School of Public Health
Ann Arbor, Michigan, United States, 48109-2029
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Noreen M. Clark, PhD University of Michigan School of Public Health
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noreen M. Clark, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01117805     History of Changes
Other Study ID Numbers: 1R18HL094272 01
Study First Received: May 3, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Asthma

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

ClinicalTrials.gov processed this record on October 23, 2014