Status:
RECRUITING
BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
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 uncont...
Detailed 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 clini...
Eligibility Criteria
Inclusion
- Inclusion Criteria (participants):
- 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.
- Exclusion Criteria (participants):
- non-English speaking
- serious mental health conditions that preclude completion of study procedures or confound analyses or
- participation in a listening session
- Inclusion Criterion (clinicians):
- 1\. those who manage a panel of adult asthma patients
- Inclusion Criteria (loved ones):
- must be identified by patient participant as a loved one and
- loved one must be a family member or friend of the patient participant.
- Exclusion Criteria (loved ones):
- non-English speaking or
- serious mental health conditions that preclude completion of study procedures or confound analyses
Exclusion
Key Trial Info
Start Date :
January 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05341726
Start Date
January 19 2023
End Date
July 1 2026
Last Update
January 28 2025
Active Locations (2)
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1
Sun River Health
Beacon, New York, United States, 12508
2
Bedford Stuyvesant Family Health Center
Brooklyn, New York, United States, 11216