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BREATHE Program for Asthma

N/A

Recruiting

Led By Maureen George, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must 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

Participants must be adults (> or = 18 years of age)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 months (post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well BREATHE works to control asthma in black adults, and identify what makes it hard or easy to implement BREATHE on a large scale.

Who is the study for?

The BREATHE trial is for Black adults with uncontrolled asthma who are at least 18 years old, receive care at urban FQHCs, and have been diagnosed with persistent asthma or had an exacerbation. Participants must self-identify as Black (of any ethnicity) and speak English. Excluded are those with serious mental health conditions that could affect participation.

What is being tested?

This study tests the BREATHE intervention's effectiveness in improving asthma control among Black adults compared to a standard control intervention. It also explores factors influencing the adoption of BREATHE in urban healthcare centers serving this community.

What are the potential side effects?

As the interventions involve non-pharmacological approaches to managing asthma, specific side effects are not detailed like medication trials; however, there may be general risks associated with changes in asthma management practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with persistent asthma and have been prescribed inhalers or had an asthma attack in the last 4 years.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 months (post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 months (post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 months (post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Asthma Control Questionnaire Score

Secondary study objectives

Mean Asthma Impairment and Risk Questionnaire Score

Mean Asthma Quality of Life Questionnaire Score

Mean Medication Adherence Report Scale - Asthma Score

+1 more

Other study objectives

Number of participants who completed post-trial interviews

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BREATHE interventionExperimental Treatment1 Intervention

The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.

Group II: Control InterventionActive Control1 Intervention

The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BREATHE Intervention

2017

N/A

~80

0 / 2Eligibility criteria met