BREATHE Program for Asthma
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byMaureen George, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Must be taking: Inhaled corticosteroids
Disqualifiers: Non-English speaking, Serious mental health, others
No Placebo Group
Trial Summary
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; and
2. 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.
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.
12345Is 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.
678910How 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.
411121314Eligibility Criteria
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.
+4 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
Trial Timeline
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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Bedford Stuyvesant Family Health CenterBrooklyn, NY
Columbia University Irving Medical CenterNew York, NY
Sun River HealthBeacon, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Assessment of an ambulatory care asthma program. [2019]In response to rising asthma morbidity and mortality, numerous comprehensive asthma programs have been developed. However, few studies have examined critically the effectiveness of such programs or the means by which treatment or outcome is altered. To assess the role of a specialized ambulatory asthma care program, we reviewed the interventions recommended to 344 patients referred for the assessment of asthma. A subset of 127 made return visits 6-12 months following their initial assessment, thereby allowing assessment of behavioral and physiological outcomes. At the initial consultation, the recommended medication changes were: inhaled beta-agonists +6% (p
In-Patient Pulmonary Rehabilitation to Improve Asthma Control–A Randomized Controlled Study (EPRA, Effectiveness of Pulmonary Rehabilitation for Patients with Asthma). [2021]Despite the availability of effective pharmaceutical treatment options, many patients with asthma do not manage to control their illness. This randomized trial with a waiting-list control group examined whether a 3-week course of inpatient pulmonary rehabilitation (PR) improves asthma control (primary endpoint) and other secondary endpoints (e.g., quality of life, cardinal symptoms, mental stress). The subsequent observational segment of the study investigated the long-term outcome after PR.
The effect of Easy Breathing on asthma management and knowledge. [2019]To determine whether Easy Breathing, an asthma management program, improves adherence to national asthma guidelines.
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]Asthma control is suboptimal, resulting in quality of life (QoL) impairment and costs. Breathing retraining exercises have evidence of effectiveness as adjuvant treatment, but are infrequently used.
Education and self-management: a one-year randomized trial in stable adult asthmatic patients. [2019]to assess the effects of an educational program in asthmatic patients, following treatment readjustment.
Breathing retraining for African-American adolescents with asthma: a pilot study of a school-based randomized controlled trial. [2022]Asthma affects approximately seven million children/adolescents in the USA, with African-American children disproportionately affected. Breathing retraining techniques have been shown to improve asthma outcomes in adults, though research in youth is limited. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a school-based randomized controlled trial of breathing retraining for asthma outcomes and anxiety symptoms in a sample of urban, African-American adolescents.
Use of inhaler devices and asthma control in severe asthma patients at a referral center in the city of Salvador, Brazil. [2019]To evaluate the use of inhaler devices by patients with severe asthma treated via the Programa para o Controle da Asma e Rinite Alérgica na Bahia(ProAR, Bahia State Asthma and Allergic Rhinitis Control Program), recording the frequency of their errors in performing key steps and the relationship between such errors and the lack of asthma control.
Educational interventions to improve inhaler techniques and their impact on asthma and COPD control: a pilot effectiveness-implementation trial. [2018]To assess the impact that educational interventions to improve inhaler techniques have on the clinical and functional control of asthma and COPD, we evaluated 44 participants before and after such an intervention. There was a significant decrease in the number of errors, and 20 patients (46%) significantly improved their technique regarding prior exhalation and breath hold. In the asthma group, there were significant improvements in the mean FEV1, FVC, and PEF (of 6.4%, 8.6%, and 8.3% respectively). Those improvements were accompanied by improvements in Control of Allergic Rhinitis and Asthma Test scores but not in Asthma Control Test scores. In the COPD group, there were no significant variations. In asthma patients, educational interventions appear to improve inhaler technique, clinical control, and functional control. RESUMO Para avaliar o impacto do ensino da técnica inalatória no controle clínico e funcional de pacientes com asma ou DPOC, incluíram-se 44 participantes antes e após essa intervenção. Houve uma diminuição significativa no número de erros cometidos, sendo que 20 pacientes (46%) melhoraram significativamente sua técnica na expiração prévia e apneia final. No grupo asma, houve significativa melhora nas médias de FEV1 (6,4%), CVF (8,6%) e PFE (8,3%), e essa melhora correlacionou-se com os resultados no Control of Allergic Rhinitis and Asthma Test, mas não com os do Asthma Control Test. No grupo DPOC, não houve variações significativas. O ensino da técnica inalatória parece melhorar seu desempenho e os controles clínico e funcional em pacientes com asma.
Asthma School Program in children and their parents. [2021]This study was undertaken to analyze the clinical efficiency of Asthma Education Intervention (AEI, Asthma School) in children and their parents, a program was designed to produce acceptable asthma knowledge and to improve the treatment.
Update on inhaled corticosteroids: safety, compliance, and new delivery systems. [2019]Since the introduction of inhaled beclomethasone, inhaled corticosteroids have revolutionized the treatment of asthma. Inhaled corticosteroids provide the most potent and consistently effective long-term control of asthma. They have become the mainstay of therapy for chronic disease and have been recommended for asthmatics of all severities. During the past two decades, after the introduction of beclomethasone, several new inhaled corticosteroids have been introduced. With more widespread use of these agents, particularly in pediatric patients, concerns about safety have risen. These concerns emanate from the use of higher dose inhaled corticosteroids and higher potency molecules. The side effects of most concern are those that are similar to those associated with systemic corticosteroids. Recently, the U.S. Food and Drug Administration (FDA) issued a class warning of potential growth suppression in some pediatric patients using inhaled corticosteroids. Patient compliance with inhaled corticosteroid therapy is problematic. Some patients think that all inhaled corticosteroid therapy is inherently dangerous because they confuse it with systemic corticosteroid or even anabolic steroid use. Most of the products are available only as metered dose inhalers. Use of these inhalers is difficult and often poorly taught to patients. The two newest inhaled corticosteroids, budesonide and fluticasone, are available as dry powder inhalers with new delivery systems.
Public health interventions for asthma: an umbrella review, 1990-2010. [2012]Asthma is a chronic respiratory disease increasingly prevalent in the U.S., particularly among children and certain minority groups. This umbrella review sought to assess and summarize existing systematic reviews of asthma-related interventions that might be carried out or supported by state or community asthma control programs, and to identify gaps in knowledge.
Adaptation of an asthma management program to a small clinic. [2022]Asthma management programs, such as the Breathmobile program, have been extremely effective in reducing asthma morbidity and increasing disease control; however, their high start-up costs may preclude their implementation in smaller health systems. In this study, we extended validated asthma disease management principles from the Breathmobile program to a smaller clinic system utilizing existing resources and compared clinical outcomes.
Breathe Well, Live Well: Implementing an Adult Asthma Self-Management Education Program. [2022]Asthma remains a significant health problem in the United States. Adults with poorly controlled asthma can affect their community in a number of ways, from lost productivity in the workplace to health care costs to premature death. Asthma self-management education helps individuals achieve better control of their asthma and is critical for the overall health and well-being of individuals with asthma. While there are numerous programs and initiatives targeting children with asthma, there is a lack of comparable focus on the needs of adults with asthma. The American Lung Association developed Breathe Well, Live Well, an adult asthma self-management education program, and launched it nationwide in 2007. The program for adults has a flexible delivery format for community-based implementation. This article describes the development, dissemination, and transformation of the program. Each stage of implementation showed positive changes in asthma self-management practices that contribute to better asthma control, and one local implementation additionally showed decreased reports of missed work and unscheduled health care visits among participants. The findings from the three evaluations support the use of Breathe Well, Live Well for broad community-based implementation to improve asthma self-management efficacy and behaviors.
Control of asthma in children. [2013]Programs designed for the control of asthma are complex. Implementation of a number of modalities may be necessary, and the mean and level of treatment may need to be varied from time to time. Medical treatment is a primary concern but preventive measures and education of the family are essential as well.