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NCT05341726Recruiting

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

BREATHE: An Efficacy-implementation Trial of a Brief Shared Decision Making Intervention Among Black Adults With Uncontrolled Asthma in Federally Qualified Health Centers (Trial and Post-trial)

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
400 (estimated)
First submitted
18 Apr 2022
Start date
19 Jan 2023
Primary completion date
Feb 2028
Lead sponsor
Columbia University
Diseases
Asthma
NCT number
NCT05341726

What you commit to

  • Study type: Interventional
  • Planned participants: 400
  • From 19 Jan 2023 to the primary completion date, Feb 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • non-English speaking
  • participation in a listening session
    • Inclusion Criterion (clinicians):
    • 1\. those who manage a panel of adult asthma patients
  • non-English speaking or

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun River Health
Coordinator of this site? Confirm its status
BeaconUnited StatesRecruiting
Bedford Stuyvesant Family Health Center
Coordinator of this site? Confirm its status
BrooklynUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.