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

Recruiting now · Not applicable

Conditions studied: COPD (Chronic Obstructive Pulmonary Disease)

In brief

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.

Key facts

Study ID

NCT05572632

Run by

University of California, San Francisco

People needed

387

Starts

2023-01-19

Expected to finish

2027-06-30

Last updated by the study team

2025-12-01

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Zuckerberg San Francisco General (ZSFG) Hospital — San Francisco, California, United States (enrolling)
• Maxine Hall Health Center (MHHC) — San Francisco, California, United States (enrolling)
• Southeast Health Center (SEHC) — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.