Women of Color and Asthma Control

NCT ID: NCT01117805

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-06-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Telephone counseling intervention

Intervention Type: BEHAVIORAL

self-regulation telephone counseling program for African American women with asthma

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telephone counseling intervention

self-regulation telephone counseling program for African American women with asthma

Intervention Type: BEHAVIORAL

Other Intervention Names

Women Breathe Free

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Randall Brown

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noreen M. Clark, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Public Health

Locations

University of Michigan School of Public Health

Ann Arbor, Michigan, United States

Countries

United States

References

Patel MR, Song PX, Sanders G, Nelson B, Kaltsas E, Thomas LJ, Janevic MR, Hafeez K, Wang W, Wilkin M, Johnson TR, Brown RW. A randomized clinical trial of a culturally responsive intervention for African American women with asthma. Ann Allergy Asthma Immunol. 2017 Feb;118(2):212-219. doi: 10.1016/j.anai.2016.11.016. Epub 2016 Dec 27.

Reference Type: DERIVED

PMID: 28034579 (View on PubMed)

Janevic MR, Sanders GM, Thomas LJ, Williams DM, Nelson B, Gilchrist E, Johnson TR, Clark NM. Study protocol for Women of Color and Asthma Control: a randomized controlled trial of an asthma-management intervention for African American women. BMC Public Health. 2012 Jan 24;12:76. doi: 10.1186/1471-2458-12-76.

Reference Type: DERIVED

PMID: 22272780 (View on PubMed)

Other Identifiers

1R18HL094272-01

Identifier Type: NIH

Identifier Source: org_study_id

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