Validation of the BREATHE Asthma Intervention Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 2 - a Pilot Randomized Trial Phase)

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: BREATHE Intervention
* Behavioral: Control Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BREATHE Intervention<br>The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention. | Behavioral: BREATHE Intervention<br>* PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.<br>|
| Active Comparator: Control Intervention<br>The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles). | Behavioral: Control Intervention<br>* PCP will provide discussion of healthy lifestyles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire (ACQ) Score | 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 | Baseline, 1 Month, 2 Months, 3 Months (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Quality of Life Questionnaire (AQLQ) Score | 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) | Baseline, 1 Month, 2 Months, 3 Months (post-intervention) | 
| Medication Adherence Record Scale-Asthma (MARS-A) Score | 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) | Baseline, 1 Month, 2 Months, 3 Months (post-intervention) |