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

Last updated: January 24, 2025
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

BREATHE Intervention

Control Intervention

Clinical Study ID

NCT05341726
AAAT0939 - trial & post-trial
R01NR019275
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is an efficacy-implementation trial to:

  1. evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and

  2. identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE in FQHCs.

Eligibility Criteria

Inclusion

Inclusion Criteria (participants):

Patients participants will

  1. be adults (> or = 18 years of age)

  2. 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

  3. 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

  4. receive asthma care at a partner FQHC and

  5. 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):

  1. non-English speaking

  2. serious mental health conditions that preclude completion of study procedures or confound analyses or

  3. participation in a listening session

Inclusion Criterion (clinicians):

  1. those who manage a panel of adult asthma patients

Inclusion Criteria (loved ones):

  1. must be identified by patient participant as a loved one and

  2. loved one must be a family member or friend of the patient participant.

Exclusion Criteria (loved ones):

  1. non-English speaking or

  2. serious mental health conditions that preclude completion of study procedures or confound analyses

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: BREATHE Intervention
Phase:
Study Start date:
January 19, 2023
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Sun River Health

    Beacon, New York 12508
    United States

    Active - Recruiting

  • Bedford Stuyvesant Family Health Center

    Brooklyn, New York 11216
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.