R01HL161049

Rehabilitation in Safety-Net Environments (RISE) for COPD - Project Abstract

Individuals with moderate-to-severe chronic obstructive pulmonary disease (COPD) are at high risk for rapid functional decline and hospitalization. Pulmonary rehabilitation is one of the few interventions that has been shown to effectively modify the course of COPD and improve health outcomes. However, challenges in implementation and access to this high-resource intervention in real-life settings have led to low availability and engagement due to both healthcare system-level and patient-level barriers.

To address barriers specific to low-resourced healthcare settings, we developed COPD Wellness with patient and clinical stakeholders. This 10-week community-based program retains key elements of pulmonary rehabilitation (exercise training, self-management, and peer social support), but is designed to be portable and feasible to deliver in diverse settings. While COPD Wellness addresses many system-level barriers, it does not directly address patient-level barriers. Lower levels of adherence are common across low-income, low health literacy communities, reflecting the burden of competing socio-environmental stressors that interfere with the ability to carry out rehabilitation activities and independently contribute to poor outcomes in COPD.

We adapted the evidence-based resource support program, Health Advocates (HA), for the unmet social needs of older patients with COPD as a strategy to improve acceptance, adherence, and impact of pulmonary rehabilitation programs (PLUS+). The proposed study will directly test the benefit of the COPD Wellness and PLUS+ program relative to usual care and estimate the added benefit of the HA in COPD Wellness PLUS+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD.

In this type 1 effectiveness-implementation hybrid design, we aim to:

1) Determine the effectiveness of COPD Wellness and PLUS+ to improve functional and symptom outcomes; and,
2) Evaluate the implementation of COPD Wellness and PLUS+ across study sites applying the RE-AIM and CFIR frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.

COPD Wellness PLUS+ was designed to specifically address barriers to rehabilitation and function within low-resourced healthcare settings. If effective, the COPD Wellness PLUS+ program can offer a feasible pathway for broader implementation of low-intensity pulmonary rehabilitation regionally and nationally in the U.S.

San Francisco Regents Of The University Of California

THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) PROVIDES GLOBAL LEADERSHIP FOR A RESEARCH, TRAINING, AND EDUCATION PROGRAM TO PROMOTE THE PREVENTION AND TREATMENT OF HEART, LUNG, AND BLOOD DISEASES AND ENHANCE THE HEALTH OF ALL INDIVIDUALS SO THAT THEY CAN LIVE LONGER AND MORE FULFILLING LIVES. THE DIVISION OF LUNG DISEASES SUPPORTS RESEARCH AND RESEARCH TRAINING ON THE CAUSES, DIAGNOSIS, PREVENTION, AND TREATMENT OF LUNG DISEASES AND SLEEP DISORDERS. RESEARCH IS FUNDED THROUGH INVESTIGATOR-INITIATED AND INSTITUTE-INITIATED GRANT PROGRAMS AND THROUGH CONTRACT PROGRAMS IN AREAS INCLUDING ASTHMA, BRONCHOPULMONARY DYSPLASIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CYSTIC FIBROSIS, RESPIRATORY NEUROBIOLOGY, SLEEP AND CIRCADIAN BIOLOGY, SLEEP-DISORDERED BREATHING, CRITICAL CARE AND ACUTE LUNG INJURY, DEVELOPMENTAL BIOLOGY AND PEDIATRIC PULMONARY DISEASES, IMMUNOLOGIC AND FIBROTIC PULMONARY DISEASE, RARE LUNG DISORDERS, PULMONARY VASCULAR DISEASE, AND PULMONARY COMPLICATIONS OF AIDS AND TUBERCULOSIS. THE DIVISION IS RESPONSIBLE FOR MONITORING THE LATEST RESEARCH DEVELOPMENTS IN THE EXTRAMURAL SCIENTIFIC COMMUNITY AS WELL AS IDENTIFYING RESEARCH GAPS AND NEEDS, OBTAINING ADVICE FROM EXPERTS IN THE FIELD, AND IMPLEMENTING PROGRAMS TO ADDRESS NEW OPPORTUNITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION; USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS; FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS; AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION; FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

San Francisco, California 94110 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the total obligations have increased 427% from $704,451 to $3,711,233.