Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Evaluating a brief intervention for asthma management in Black adults

Official title: 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)

Run by Columbia University · NCT05341726 · Data updated 2026-11-12

This study is testing a quick 9-minute asthma management approach called BREATHE to see if it helps Black adults with uncontrolled asthma feel better and manage their condition more effectively.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorColumbia University
Academic / other
Drugs / interventionsPrednisone
Locations2 sites (Beacon, New York and 1 other locations)
StatusRecruiting
StartedJanuary 19, 2023
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedOctober 23, 2026
Trial IDNCT05341726 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are Black adults aged 18 and older with clinician-diagnosed persistent asthma who receive care at a partner FQHC.

Probably not a fit

Patients who are non-English speaking or have serious mental health conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the efficacy of the BREATHE intervention, a 9-minute shared decision-making approach designed to improve asthma control among Black adults with uncontrolled asthma. The study will involve 200 participants receiving care at urban federally qualified health centers (FQHCs) and aims to identify barriers and facilitators to implementing this intervention widely. The BREATHE intervention is unique as it is integrated into routine office visits and delivered by the patient's own healthcare provider. Additionally, post-trial interviews will assess participant satisfaction and the acceptability of the intervention.

Why it matters

Potential benefit: If successful, this intervention could significantly improve asthma management and health outcomes for Black adults suffering from uncontrolled asthma.

How similar studies have gone: Previous pilot trials have shown success with similar interventions, indicating potential for positive outcomes in this study.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Sun River Health
    Beacon, New York, United States
    Recruiting
  • Bedford Stuyvesant Family Health Center
    Brooklyn, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Maureen George, PhD — Columbia University School of Nursing
  • Study coordinator: Maureen George, PhD
  • Email: mg3656@cumc.columbia.edu
  • Phone: 2123051175

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.