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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Asthma Control Questionnaire Score

Secondary outcome measures

Mean Asthma Impairment and Risk Questionnaire Score

Mean Asthma Quality of Life Questionnaire Score

Mean Medication Adherence Report Scale - Asthma Score

+1 more

Other outcome measures

Number of participants who completed post-trial interviews

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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,460,615 Total Patients Enrolled

20 Trials studying Asthma

4,719 Patients Enrolled for Asthma

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,161 Total Patients Enrolled

17 Trials studying Asthma

2,407 Patients Enrolled for Asthma

Maureen George, PhDPrincipal InvestigatorColumbia University School of Nursing

6 Previous Clinical Trials

576 Total Patients Enrolled

5 Trials studying Asthma

516 Patients Enrolled for Asthma

Media Library

BREATHE Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05341726 — N/A

Asthma Research Study Groups: Control Intervention, BREATHE intervention

Asthma Clinical Trial 2023: BREATHE Intervention Highlights & Side Effects. Trial Name: NCT05341726 — N/A

BREATHE Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05341726 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical experience still open?

"Data from clinicaltrials.gov informs that despite the trial's initial posting on December 1st 2022 and most recent editing on October 11th 2022, it is not presently enrolling participants. However, there are 322 other experiments actively seeking volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma

Maureen George 2023. "BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05341726.

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