Women of Color and Asthma Control
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials
| City: |
|
Ann Arbor |
| State: |
|
Michigan |
| Zip Code: |
|
48109 |
| Conditions: |
|
Asthma |
| 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.
|
| Study Summary: |
|
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.
|
| 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
|
| NCT ID: |
|
NCT01117805 |
| Primary Contact: |
|
Principal Investigator
Noreen M. Clark, PhD
University of Michigan School of Public Health
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Ann Arbor, Michigan 48109
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|