BREATHE Intervention for Asthma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sun River Health, Beacon, NY
Asthma
BREATHE Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is an efficacy-implementation trial to: evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)

Baseline (immediately post-intervention)
Mean Shared Decision Making-Questionnaire-9 Score
Month 12
Mean Asthma Control Questionnaire Score
Mean Medication Adherence Report Scale - Asthma Score
Month 12
Mean Asthma Impairment and Risk Questionnaire Score
Mean Asthma Quality of Life Questionnaire Score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Intervention
1 of 2
BREATHE intervention
1 of 2
Active Control
Experimental Treatment

400 Total Participants · 2 Treatment Groups

Primary Treatment: BREATHE Intervention · No Placebo Group · N/A

BREATHE intervention
Behavioral
Experimental Group · 1 Intervention: BREATHE Intervention · Intervention Types: Behavioral
Control Intervention
Behavioral
ActiveComparator Group · 1 Intervention: Control Intervention · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BREATHE Intervention
2017
N/A
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 months (post-intervention)
Closest Location: Sun River Health · Beacon, NY
Photo of new york 1Photo of new york 2Photo of new york 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Asthma
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
514 Previous Clinical Trials
284,130 Total Patients Enrolled
15 Trials studying Asthma
2,286 Patients Enrolled for Asthma
Columbia UniversityLead Sponsor
1,266 Previous Clinical Trials
1,573,416 Total Patients Enrolled
18 Trials studying Asthma
4,418 Patients Enrolled for Asthma
Maureen George, PhDPrincipal InvestigatorColumbia University School of Nursing
4 Previous Clinical Trials
206 Total Patients Enrolled
3 Trials studying Asthma
186 Patients Enrolled for Asthma

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are self-reported as 'Black' race (African American, African, Caribbean, West Indian, multi-racial [Black AND one or more additional races]) AND identify their ethnicity as Hispanic OR non-Hispanic.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.