NCT05341726 BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
| NCT ID | NCT05341726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-01-19 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2023-01-19 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Maureen George, PhD
PRINCIPAL INVESTIGATOR
Columbia University School of Nursing
Frequently Asked Questions
Who can join the NCT05341726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05341726 currently recruiting?
Yes, NCT05341726 is actively recruiting participants. Contact the research team at mg3656@cumc.columbia.edu for enrollment information.
Where is the NCT05341726 trial being conducted?
This trial is being conducted at Beacon, United States, Brooklyn, United States.
Who is sponsoring the NCT05341726 clinical trial?
NCT05341726 is sponsored by Columbia University. The principal investigator is Maureen George, PhD at Columbia University School of Nursing. The trial plans to enroll 400 participants.
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