Clinical trial NCT01117805: Women of Color and Asthma Control
Official title: Women of Color and Asthma Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 422
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Emergency department visits - 1st time point
timeFrame: 12months prior to baseline interview
measure: Emergency Department Visits -2nd time point
timeFrame: Interval between baseline interview and 12 month interview
measure: Emergency Department Visits - 3rd time point
timeFrame: Interval between 12 month and 24 month telephone interview
Secondary outcomes:
measure: Hospitalizations - first time point
timeFrame: Year prior to baseline interview
measure: Hospitalizations related to asthma - 2nd time point
timeFrame: interval between baseline and 12 month interview
measure: Hospitalizations related to asthma - 3rd time point
timeFrame: interval between 12month and 24 month telephone interview
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Public Health
state: Michigan
Study officials:
affiliation: University of Michigan School of Public Health
name: Noreen M. Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.