BREATHE-BRinging Exercise, Asthma Assessments, TeacHing to Everyone

Blue Marble Rehab, Inc., Altadena CA

Investigators

Abstract

Over 25 million (M) Americans have asthma, 20M of whom are adults, who are six times more likely to die from asthma than children. Asthma cannot be cured, but it can be managed with repeated cycles of assessment, treatment, and adjustment of interventions for asthma symptoms, risk factors, and comorbidities. Asthma Self-Management Education (ASME) is recommended for all people with asthma. ASME improves quality of life and reduces unscheduled doctor visits, missed workdays, asthma-related emergency department (ED) visits, urgent care (UC) visits, and hospitalizations. The problem is only 21% of adults with asthma receive ASME, and the proportion is lower for adults who are facing heath disparities. During Phase 1, we developed the minimal viable product of BREATHE (BRinging asthma Education, Assessments, and Exercise To Everyone) as part of the comprehensive Blue Marble Health Chronic Disease Self-Management Platform. Our Allergy and Asthma Network collaborators have begun using it to support their virtual asthma coaching program. This application’s broad, long-term objectives are to leverage the Platform to develop further and evaluate BREATHE, an ASME tool that includes patient-facing asthma-related education, assessments, exercise, personalized action plans, and individualized self-management programs as well as clinician-facing data visualization dashboards. In Aim 1, we will address Phase 1 feasibility study data outcomes by adding new features that expand the content and improve the usability of the Platform. Aim 2 will compare 8 health coaching sessions + BREATHE for symptom management with 2 health coaching sessions + BREATHE for self-guided education and symptom management to improve asthma control. We will use a decentralized, randomized, parallel-group, unblinded clinical trial with an open-label phase with extended follow-up. The primary outcome is the change in asthma control measured by the Asthma Control Test (ACT) from baseline to primary endpoint after the Intervention Phase. Secondary outcomes will measure the effect of the intervention and maintenance phase (6 and 12 months) on 1) patient-reported health benefits - measured by the Severe Asthma Questionnaire (SAQ, ACT, AIRQ, Asthma Exacerbation Survey, Asthma Symptom Survey), and 2) healthcare utilization - measured by all-cause hospitalizations, asthma exacerbations, ED/UC visits, unplanned MD visits, hospitalizations, EQ-5D-5L, and time to first exacerbation. We will evaluate adherence and the degree to which participants found the program beneficial. Finally, using the daily interactive Asthma Action Plan, we will explore how asthma symptoms change over time. Fifty-six adults with asthma (50% or more of whom experience health disparities) who have not participated in asthma health coaching in the past five years and have ACT scores of <20 will participate. This grant is relevant to the NHLBI’s mission of health-relatedness because asthma is a costly condition that is often poorly managed, and this is more pronounced in adults facing health disparities. This application also directly addresses the NHLBI SBIR requests for proposals to develop tools and platforms to improve the dissemination and implementation of evidence-based interventions for lung diseases and disorders.