Women of Color and Asthma Control

University of Michigan

Status: Completed

Conditions: Asthma

Treatments: Behavioral: Telephone counseling intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01117805

1R18HL094272-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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422 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telephone counseling intervention

usual care

No Intervention group

Description:

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.