N/A
Completed N=80
Validation of the BREATHE Asthma Intervention Trial
Source: ClinicalTrials.gov NCT03300752 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Sep 2021
Primary outcomePrimary: Asthma Control Questionnaire (ACQ) Score — 2.94; 2.63; 2.17; 2.16 score on a scale
Summary
The overall goal of this study to preliminarily validate a novel intervention delivered by primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in federally qualified health centers (FQHCs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control Questionnaire (ACQ) Score |
2.94; 2.63; 2.17; 2.16; 2.22; 2.35 | — |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ) Score |
3.50; 3.65; 4.03; 4.07; 3.97; 4.18 | — |
| SECONDARY Medication Adherence Record Scale-Asthma (MARS-A) Score |
3.95; 3.88; 4.07; 4.12; 4.28; 4.18 | — |
Eligibility Criteria
PROVIDER RECRUITMENT
Inclusion Criteria
- PCPs (MDs and Nurse Practitioners (NPs)/Physician Assistants (PAs)) working in family, primary or internal medicine care services
- Who have at least 40 adult patients with persistent asthma (defined as having been prescribed ICS) on their patient panel
Exclusion Criteria
- PCPs whose primary focus is outside of adult health services (family, primary or internal medicine), such as behavioral health, pediatrics and Obstetrics and Gynaecology (OB-GYN)
PATIENT RECRUITMENT
Inclusion Criteria
Patients must be
- adults (> or = 18 years of age) who self-report race as Black or African American
- with PCP-diagnosed persistent asthma
- prescribed ICS
- receiving asthma care at participating FQHCs
- who have uncontrolled asthma
- have erroneous personal health and/or negative ICS beliefs
Exclusion Criteria
- participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
- non-English speaking
- serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses
Data sourced from ClinicalTrials.gov (NCT03300752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.