400 Participants Needed

BREATHE Program for Asthma

Recruiting at 2 trial locations
MG
Overseen ByMaureen George, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
Must be taking: Inhaled corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is an efficacy-implementation trial to:1. evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and2. identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE in FQHCs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is the BREATHE Program for Asthma safe for humans?

The research articles provided do not contain specific safety data for the BREATHE Program for Asthma or related interventions. However, they discuss educational interventions and inhaler techniques, which generally focus on improving asthma management without indicating any safety concerns.12345

How is the BREATHE Program for Asthma treatment different from other asthma treatments?

The BREATHE Program for Asthma is unique because it focuses on self-management education, helping individuals better control their asthma through personalized strategies and community-based support, rather than relying solely on medication.678910

What data supports the effectiveness of the BREATHE Intervention treatment for asthma?

Research shows that pulmonary rehabilitation and breathing retraining exercises can improve asthma control and quality of life. These components are similar to the BREATHE Intervention, suggesting it may also be effective in managing asthma.1011121314

Who Is on the Research Team?

MG

Maureen George, PhD

Principal Investigator

Columbia University School of Nursing

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants must self-report race as 'Black' race (African American, African, Caribbean, West Indian, multi-racial [Black AND one or more additional races]); identify their ethnicity as Hispanic OR non-Hispanic
Participants must receive asthma care at a partner FQHC
I have been diagnosed with persistent asthma and have been prescribed inhalers or had an asthma attack in the last 4 years.
See 3 more

Exclusion Criteria

Participants must have serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session
Loved ones must be non-English speaking or have serious mental health conditions that preclude completion of study procedures or confound analyses
Participants must be non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a one-time 9-minute shared decision-making intervention integrated into an office visit for asthma management

1 day
1 visit (in-person)

Follow-up

Participants are monitored for asthma control, medication adherence, and quality of life improvements

12 months
Multiple assessments at 1, 2, 3, 6, 9, and 12 months

Post-trial Interviews

Qualitative interviews conducted to assess satisfaction and acceptability of the intervention

up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • BREATHE Intervention
  • Control Intervention
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: BREATHE interventionExperimental Treatment1 Intervention
Group II: Control InterventionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Published Research Related to This Trial

A specialized ambulatory asthma care program significantly improved patient outcomes, with a 60% reduction in emergency room visits and an increase in lung function (FEV1) from 2.41 to 2.64 liters over 6-12 months.
The program led to increased use of inhaled steroids and decreased reliance on theophylline, resulting in fewer asthma exacerbations and a shift in patient classification towards milder forms of asthma.
Assessment of an ambulatory care asthma program.Dzyngel, B., Kesten, S., Chapman, KR.[2019]
A 3-week inpatient pulmonary rehabilitation program significantly improved asthma control in 412 adults with uncontrolled asthma, raising their average Asthma Control Test (ACT) score from 15.76 to 20.38 points, which is clinically relevant.
The benefits of pulmonary rehabilitation extended beyond immediate improvements, as participants maintained a higher ACT score of 19.00 points one year later, along with improvements in quality of life and symptoms like dyspnea and cough.
In-Patient Pulmonary Rehabilitation to Improve Asthma Control–A Randomized Controlled Study (EPRA, Effectiveness of Pulmonary Rehabilitation for Patients with Asthma).Schultz, K., Wittmann, M., Wagner, R., et al.[2021]
The Easy Breathing asthma management program significantly improved clinicians' knowledge and adherence to national asthma guidelines, with adherence rates reaching 93% to 99% after implementation.
Despite the increase in guideline adherence and a three-fold rise in inhaled corticosteroid prescriptions, physicians felt they had not made substantial changes in their practice, indicating a potential gap between perceived and actual adherence.
The effect of Easy Breathing on asthma management and knowledge.Cloutier, MM., Wakefield, DB., Carlisle, PS., et al.[2019]

Citations

Assessment of an ambulatory care asthma program. [2019]
In-Patient Pulmonary Rehabilitation to Improve Asthma Control–A Randomized Controlled Study (EPRA, Effectiveness of Pulmonary Rehabilitation for Patients with Asthma). [2021]
The effect of Easy Breathing on asthma management and knowledge. [2019]
A randomised controlled study of the effectiveness of breathing retraining exercises taught by a physiotherapist either by instructional DVD or in face-to-face sessions in the management of asthma in adults. [2021]
Education and self-management: a one-year randomized trial in stable adult asthmatic patients. [2019]
Breathing retraining for African-American adolescents with asthma: a pilot study of a school-based randomized controlled trial. [2022]
Use of inhaler devices and asthma control in severe asthma patients at a referral center in the city of Salvador, Brazil. [2019]
Educational interventions to improve inhaler techniques and their impact on asthma and COPD control: a pilot effectiveness-implementation trial. [2018]
Asthma School Program in children and their parents. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Update on inhaled corticosteroids: safety, compliance, and new delivery systems. [2019]
Public health interventions for asthma: an umbrella review, 1990-2010. [2012]
12.United Statespubmed.ncbi.nlm.nih.gov
Adaptation of an asthma management program to a small clinic. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Breathe Well, Live Well: Implementing an Adult Asthma Self-Management Education Program. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Control of asthma in children. [2013]
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