Evaluating a brief intervention for asthma management in Black adults
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)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 2 sites (Beacon, New York and 1 other locations) |
| Trial ID | NCT05341726 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are non-English speaking or have serious mental health conditions may not benefit from this study.
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 performed: Previous pilot trials have shown success with similar interventions, indicating potential for positive outcomes in this study.
Eligibility criteria
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 this trial is running
Beacon, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.