BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma


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This study is an efficacy-implementation trial to:

evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and
identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE in FQHCs.

Targeted Conditions

Study Overview

Start Date
January 19, 2023
Completion Date
January 1, 2025
Date Posted
April 22, 2022
Accepts Healthy Volunteers?


Full Address
Sun River Health
Beacon, New York 12508, United States

Bedford Stuyvesant Family Health Center
Brooklyn, New York 11216, United States


Minimum Age (years)
Eligibility Criteria
Inclusion Criteria (participants):

Patients participants will

be adults (> or = 18 years of age)
self-report race as 'Black' race (African American, African, Caribbean, West Indian, multi-racial [Black AND one or more additional races]); identify their ethnicity as Hispanic OR non-Hispanic
have clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 48 months) or have had an asthma exacerbation (e.g., ER visit, course of Prednisone) regardless of controller medicine use
receive asthma care at a partner FQHC and
screen positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey.

Exclusion Criteria (participants):

non-English speaking
serious mental health conditions that preclude completion of study procedures or confound analyses or
participation in a listening session

Inclusion Criterion (clinicians):

1. those who manage a panel of adult asthma patients

Inclusion Criteria (loved ones):

must be identified by patient participant as a loved one and
loved one must be a family member or friend of the patient participant.

Exclusion Criteria (loved ones):

non-English speaking or
serious mental health conditions that preclude completion of study procedures or confound analyses

Study Contact Info

Study Contact Name
Maureen George, PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
FDA Regulated Device?
Detailed Description
Black adults with asthma are an appropriate target for shared decision-making (SDM) interventions that support disease self-management as Black adults experience a higher asthma burden and worse clinical outcomes than non-Black adults and/or children with asthma of any racial-ethnic background. To date, the application of SDM and community-based interventions targeting Black adults have failed to address these disparities. Therefore, the investigator used patient input to develop BREATHE - BRief intervention to Evaluate Asthma THErapy - a 9-minute SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and established its efficacy in this health disparity population. This intervention is unique in that it is a one-time brief, tailored intervention integrated into office visits, using the patient's own provider as the interventionist (e.g. scalable). A previously conducted pilot trial demonstrated high fidelity to BREATHE delivery and improved asthma control and reduced symptoms among BREATHE participants compared to a dose-matched attention control condition.

We will conduct post-trial mixed-method interviews with patient participants, their loved ones, and PCPs using evaluation frameworks to determine satisfaction with, and acceptability of, the active and control interventions.
NCTid (if applicable)