Recruiting

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

Sponsor:

UCLA

Code:

NCT05572632

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

COPD Wellness

COPD Wellness Plus+

Usual Care

Study Details

Brief summary:

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Study ID

NCT05572632

Start date

Jan 19, 2023

Status verified date

Nov, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

387 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: COPD Wellness

This arm, COPD Wellness gives low-intensity exercise component with pulmonary rehabilitation for individuals with moderate-to-severe COPD. COPD Wellness is a program that was built from the Better Breathing Program, that is a part of San Francisco Health Network (SFHN) standard care for COPD.

active comparator: Usual Care

This includes access to comprehensive primary care services. 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. This program consists of an evidence-based curriculum that improves disease knowledge and management skills but has no effect on symptoms or functional status. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.

experimental: COPD Wellness Plus+

This arm includes COPD Wellness Plus+. This arm is built from COPD Wellness with the addition of Health Advocates (i.e. Plus+). This intervention seeks to understand the effects of addressing social needs on overall health and wellness through Zuckerberg San Francisco General Hospital's (ZSFG) Health Advocate (HA) program; participation and engagement with the HA's will serve as an adherence strategy.

Interventions

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.

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.

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.

Primary outcome measure

Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit [ Time Frame: 3-month (End of intervention) visit ]

Central Contacts and Locations

Central contacts

Neeta Thakur, MD, MPH

628-206-8314 neeta.thakur@ucsf.edu

Valeria M Rojas, BS

408-840-1971 Valeria.rojas@ucsf.edu

Locations

Zuckerberg San Francisco General (ZSFG) Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Neeta Thakur, MD, MPH

628-206-8314 neeta.thakur@ucsf.edu

Maxine Hall Health Center (MHHC)

Recruiting

San Francisco, California, United States, 94115

Southeast Health Center (SEHC)

Recruiting

San Francisco, California, United States, 94124

More Information

Sponsor

University of California, San Francisco

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Keywords

Social Needs
Chronic Disease
Health Disparities
Lung Diseases
Community Resources

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-12-01.