BREATHE Program for Asthma

Recruiting at 2 trial locations

Overseen By Maureen George, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Inhaled corticosteroids

Disqualifiers: Non-English speaking, Serious mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called the BREATHE Intervention to help Black adults manage uncontrolled asthma. The trial will compare the effectiveness of BREATHE to standard advice on nutrition and lifestyle from doctors. Participants will receive a brief intervention during an office visit, focusing on correcting misunderstandings about asthma and medication. The trial seeks Black adults who have experienced asthma attacks or use inhaled medications and receive care at specific health centers. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance asthma management for the community.

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.

What prior data suggests that the BREATHE intervention is safe for asthma patients?

Research shows that the BREATHE program is safe for people with asthma. Studies have found that similar programs, which include breathing exercises and asthma education, improve patients' quality of life without causing harm, meaning people usually don't experience adverse side effects.

Other research has shown that breathing exercises help with asthma symptoms without negative effects, suggesting that participants should find the BREATHE program manageable.

Overall, evidence indicates that the BREATHE program is a safe choice for those seeking better asthma management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BREATHE intervention for asthma stands out because it emphasizes motivational interviewing and shared decision-making, which are not typically central to standard asthma care. Unlike the usual reliance on medications like inhaled corticosteroids, this approach aims to address patients' misconceptions about their condition and medication through a personalized, one-time, 9-minute conversation with their primary care provider. This method could empower patients with better asthma management strategies by correcting erroneous beliefs and fostering collaboration in treatment decisions, offering a fresh angle on controlling asthma symptoms. Researchers are excited about this approach because it could enhance patient engagement and potentially improve asthma outcomes by integrating behavioral strategies into routine care.

What evidence suggests that the BREATHE intervention could be effective for asthma?

This trial will compare the BREATHE intervention with a Control Intervention. Research has shown that the BREATHE program might help people manage asthma better through breathing exercises. One study found that these exercises improved the quality of life for people with uncontrolled asthma without causing harm. Another study showed positive results from the exercises even months after starting the program. This evidence suggests that the BREATHE program could help manage asthma symptoms through specific breathing techniques. ^{4 6 7 8 9}

Who Is on the Research Team?

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 receive asthma care at a partner FQHC

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

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

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?

Group I: BREATHE intervention Experimental Treatment 1 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 Intervention Active Control 1 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.

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

The adapted asthma management program in a smaller clinic successfully reduced emergency department visits by 69% and hospitalizations by 92% over one year, demonstrating significant improvements in asthma control.

By utilizing existing resources and staff, the program achieved comparable outcomes to larger systems, with up to 70% of patients reaching asthma control by their third visit, indicating that effective asthma management can be implemented in smaller health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of an asthma management program to a small clinic. Kwong, KY., Redjal, N., Scott, L., et al.[2022]

The Breathe Well, Live Well program, developed by the American Lung Association, effectively improves asthma self-management practices among adults, contributing to better asthma control.

Local implementations of the program have shown positive outcomes, including reduced missed work and fewer unscheduled healthcare visits, highlighting its potential for community-based application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathe Well, Live Well: Implementing an Adult Asthma Self-Management Education Program. Gardner, EA., Kaplan, BM., Collins, P., et al.[2022]

Asthma management requires a multifaceted approach, combining medical treatment with preventive measures and family education to effectively control the condition.

The complexity of asthma programs means that treatment levels and methods may need to be adjusted over time to meet the individual needs of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of asthma in children. Dolovich, J., Hargreave, FE., Wilson, WM.[2013]

The Asthma Education Intervention (AEI) significantly improved asthma knowledge, compliance with treatment, and inhalation technique among 231 children with asthma and their parents over 12 months, with knowledge scores increasing from 63% to 82%.

Despite these improvements in knowledge and treatment practices, there was no change in attitudes or behaviors regarding asthma prognosis among adolescents and their parents, indicating that while education is effective, it may not fully address all aspects of asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma School Program in children and their parents. Zivković, Z., Radić, S., Cerović, S., et al.[2021]

Inhaled corticosteroids, particularly since the introduction of beclomethasone, have become the most effective long-term treatment for asthma, recommended for patients of all severities.

Concerns about safety, especially regarding potential growth suppression in pediatric patients, have arisen with the increased use of higher dose and more potent inhaled corticosteroids, leading to confusion among patients about their safety compared to systemic corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on inhaled corticosteroids: safety, compliance, and new delivery systems. Simon, RA.[2019]

An educational program for asthmatic patients did not significantly increase the number of symptom-free days compared to a control group, with both groups achieving around 88-89% symptom-free days over one year.

However, patients in the education group who strictly followed their self-management plans had a notably higher percentage of symptom-free days (97%) compared to those who did not comply as well (87%), highlighting the importance of adherence to management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and self-management: a one-year randomized trial in stable adult asthmatic patients. Couturaud, F., Proust, A., Frachon, I., et al.[2019]

A pilot study involving 33 urban African-American adolescents showed that breathing retraining techniques are feasible and acceptable in a school setting, with a high retention rate of 90%.

While both asthma control and quality of life improved over time, and state anxiety decreased significantly after the intervention, there were no significant differences between the breathing retraining and control groups, indicating that further research is needed to establish efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathing retraining for African-American adolescents with asthma: a pilot study of a school-based randomized controlled trial. Bignall, WJ., Luberto, CM., Cornette, AF., et al.[2022]

The review of 42 systematic reviews highlighted that self-management education and comprehensive home-based interventions to reduce indoor asthma triggers are effective strategies for managing asthma, particularly in children.

There is a need for state and community asthma control programs to focus on implementing proven interventions and to evaluate new strategies that have not been thoroughly assessed, as many existing studies had limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public health interventions for asthma: an umbrella review, 1990-2010. Labre, MP., Herman, EJ., Dumitru, GG., et al.[2012]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 467 severe asthma patients in Brazil, most demonstrated appropriate inhalation techniques with their inhaler devices, particularly with the Aerolizer®, where 71.3% performed all essential steps correctly.

Proper inhalation technique was linked to better asthma control, highlighting the importance of training and periodic checks in managing asthma effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of inhaler devices and asthma control in severe asthma patients at a referral center in the city of Salvador, Brazil. Coelho, AC., Souza-Machado, A., Leite, M., et al.[2019]

In a study of 44 participants, educational interventions significantly improved inhaler techniques in asthma patients, with 46% of participants showing better techniques, particularly in prior exhalation and breath hold.

Asthma patients experienced notable improvements in lung function measures (FEV1, FVC, and PEF) after the intervention, indicating enhanced clinical and functional control, while no significant changes were observed in the COPD group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational interventions to improve inhaler techniques and their impact on asthma and COPD control: a pilot effectiveness-implementation trial. Maricoto, T., Madanelo, S., Rodrigues, L., et al.[2018]

A three-session breathing retraining program, delivered either through a DVD or face-to-face physiotherapy, significantly improved asthma-related quality of life (QoL) compared to usual care, with both methods showing similar effectiveness.

Both interventions also resulted in lower healthcare costs and fewer adverse events compared to the control group, suggesting that self-guided breathing retraining could be a safe and effective option for adults with uncontrolled asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Thomas, M., Bruton, A., Little, P., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Easy Breathing on asthma management and knowledge. Cloutier, MM., Wakefield, DB., Carlisle, PS., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7096190/

Breathing exercises for adults with asthma - PMC When assessed from four to six months, the results favoured breathing exercises (MD 0.38, 95% CI 0.08 to 0.68; 1 study, 183 participants). Hyperventilation ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK587705/

Evaluation of the My Breathing Matters intervention - NCBI There was no statistically significant difference in the number of patients who showed minimal clinically important difference improvement at 3 or 12 months ...

3. nature.com nature.com/articles/s41598-022-25447-0

Efficacy and feasibility of the BREATHE asthma ... This study aimed to evaluate the efficacy and feasibility of the BREATHE intervention with parents and AI children, during a 3-year follow-up period.

4. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202111-1228OC

Breathing Exercises for Patients with Asthma in Specialist ... BrEX as add-on to usual care improve asthma-related QoL in incompletely controlled asthma regardless of severity and with no evidence of harm.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/clt2.70049

Breath of relief: Transforming pediatric asthma care with ... The aim of this randomized, controlled, single-blind study was to investigate the effectiveness of breathing exercises in asthma patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12348406/

Project BREATHE: A Quality Improvement Initiative - PMC During this period, the average completion rate of the AAP was 58%. Asthma severity and control assessments were performed 58% of the time, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9731995/

Efficacy and feasibility of the BREATHE asthma intervention ... This study aimed to evaluate the efficacy and feasibility of the BREATHE intervention with parents and AI children, during a 3-year follow-up period.

8. researchgate.net researchgate.net/publication/49674570_The_Breathe-Easy_Home_The_Impact_of_Asthma-Friendly_Home_Construction_on_Clinical_Outcomes_and_Trigger_Exposure

The Breathe-Easy Home: The Impact of Asthma-Friendly ... BEH residents' asthma-symptom-free days increased from a mean of 8.6 per 2 weeks in their old home to 12.4 after 1 year in the BEH. The ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05341726

BREATHE: An Efficacy-implementation Trial Among Black ... This study is an efficacy-implementation trial to: evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally ...