RECRUITINGINTERVENTIONAL

Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD

About This Trial

Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US, disproportionately affects low socioeconomic communities. While few interventions effectively modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable exception. However, implementation of this resource-intensive program in real-life settings, and in particular, for underserved communities, has proven to be challenging. Safety-net centers that serve primarily under-insured populations lack financial resources to provide pulmonary rehabilitation. The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.

Who May Be Eligible (Plain English)

Who May Qualify: - Provision of signed and dated willing to sign a consent form form - Willingness to participate in the COPD Wellness program - 40 to 90 years old - English or Spanish speaking - Physician-diagnosed COPD - Spirometry-confirmed FEV1/FVC ratio \<= 0.7 and FEV1% predicted \<80% based on GLI-O prediction equation - COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy - Currently prescribed COPD medication(s) - Ability to exercise with lower extremities - No COPD exacerbations for ≥ 6 weeks - Currently receiving care within SFHN - Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC) Who Should NOT Join This Trial: - Pregnancy - Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating - Unstable cardiovascular disease (includes recent \[\<6 months\] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure) - Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist) - Transmittable pulmonary infection (tuberculosis, COVID19) - Participated in pulmonary rehabilitation in the past 12-months - COPD exacerbation in the past 6 weeks - Activities restrictions that limit one's ability to engage in moderate physical activity - Other diagnosis or condition that carry a prognosis of death within the next year Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Provision of signed and dated informed consent form * Willingness to participate in the COPD Wellness program * 40 to 90 years old * English or Spanish speaking * Physician-diagnosed COPD * Spirometry-confirmed FEV1/FVC ratio \<= 0.7 and FEV1% predicted \<80% based on GLI-O prediction equation * COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy * Currently prescribed COPD medication(s) * Ability to exercise with lower extremities * No COPD exacerbations for ≥ 6 weeks * Currently receiving care within SFHN * Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC) Exclusion Criteria: * Pregnancy * Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating * Unstable cardiovascular disease (includes recent \[\<6 months\] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure) * Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist) * Transmittable pulmonary infection (tuberculosis, COVID19) * Participated in pulmonary rehabilitation in the past 12-months * COPD exacerbation in the past 6 weeks * Activities restrictions that limit one's ability to engage in moderate physical activity * Other diagnosis or condition that carry a prognosis of death within the next year

Treatments Being Tested

BEHAVIORAL

COPD Wellness

COPD Wellness consists of 10 weekly sessions led by the COPD Wellness Coach. The intervention was designed to be portable, rely on little equipment, and require limited space (\~300sqft). The curriculum was iteratively developed with patient input and builds behavioral capability and self-efficacy through 30 minutes blocks of disease education and self-management skill building, exercise training, and social support.

BEHAVIORAL

COPD Wellness Plus+

Couples COPD Wellness with the ZSFG Health Advocates Program. The HA will help the participant prioritize identified needs and, using an algorithm informed approach to connect the individual to the needed resource, this includes providing referrals to outside social or legal service agencies, help with applications for social benefits, or other services. The HA will use a checklist to track activities including review and prioritization of needs, referrals or resources provided, and contacts/contact attempts.

BEHAVIORAL

Usual Care

Includes access to comprehensive primary care services that is standardized across the SFHN. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.

Locations (3)

Zuckerberg San Francisco General (ZSFG) Hospital

San Francisco, California, United States

Maxine Hall Health Center (MHHC)

San Francisco, California, United States

Southeast Health Center (SEHC)

San Francisco, California, United States