Validation of the BREATHE Asthma Intervention Trial

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Control Intervention; Behavioral: BREATHE Intervention

• Registration Number: NCT03300752
• Lead Sponsor: Columbia University

Brief 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).

Detailed Description

Nearly every asthma related hospitalization and death could be prevented with appropriate self-management that achieves and maintains disease control. However, as many as 64% of adults have uncontrolled asthma; minorities are disproportionately represented within that population. While inhaled corticosteroids (ICS) are a safe and effective treatment for uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence.

Black adults with uncontrolled asthma experience profound health disparities. Despite data that point to the critical need for enhanced asthma self-management, rates of controlled asthma are well below Healthy People 2020 targets, particularly among vulnerable populations. This Brief Evaluation of Asthma Therapy (BREATHE) intervention has the potential to offer a new avenue to asthma control via shared decision-making that supports ICS adherence.

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-09-29
• Study Start: 2017-10-01
• Study First Posted: 2017-10-03
• Primary Completion: 2019-05-29
• Study Completion: 2019-05-30
• Results First Submitted: 2021-06-09
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Results First Posted: 2021-09-28
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

1. adults (> or = 18 years of age) who self-report race as Black or African American
2. with PCP-diagnosed persistent asthma
3. prescribed ICS
4. receiving asthma care at participating FQHCs
5. who have uncontrolled asthma
6. have erroneous personal health and/or negative ICS beliefs

Exclusion Criteria:

1. participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
2. non-English speaking
3. serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Intervention	Control Intervention	The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).
BREATHE Intervention	BREATHE Intervention	The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.

Primary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire (ACQ) Score	Baseline, 1 Month, 2 Months, 3 Months (post-intervention)	Full title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome

Secondary Outcome Measures

Name	Time	Method
Asthma Quality of Life Questionnaire (AQLQ) Score	Baseline, 1 Month, 2 Months, 3 Months (post-intervention)	Full title: Asthma Quality of Life Questionnaire Construct: quality of life for patients with asthma Scoring: 32 items, each scored 1-7. The total score is calculated as a mean of all 32 items (1= low quality of life/ worse outcome, 7= high quality of life/ best outcome)
Medication Adherence Record Scale-Asthma (MARS-A) Score	Baseline, 1 Month, 2 Months, 3 Months (post-intervention)	Full title: Medication Adherence Record Scale- Asthma Construct: Adherence to inhaled corticosteroid medications Scoring: Total score is calculated as a mean of the 10 items, scores range from 1-5 (1= low adherence/ worse outcome, 5= high adherence/ best outcome)

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States