BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Recruiting · NCT05341726 · Interventional (participants receive a specific treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
BREATHE InterventionControl Intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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):
- \. 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
Where it is running
2 locations listed across 1 US state.
- Sun River Health - Beacon, New York, United States
- Bedford Stuyvesant Family Health Center - Brooklyn, New York, United States