NCT05572632 Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
| NCT ID | NCT05572632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | COPD (Chronic Obstructive Pulmonary Disease) |
| Study Type | INTERVENTIONAL |
| Enrollment | 387 participants |
| Start Date | 2023-01-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 387 participants in total. It began in 2023-01-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Neeta Thakur, MD, MPH
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05572632 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying COPD (Chronic Obstructive Pulmonary Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05572632 currently recruiting?
Yes, NCT05572632 is actively recruiting participants. Contact the research team at neeta.thakur@ucsf.edu for enrollment information.
Where is the NCT05572632 trial being conducted?
This trial is being conducted at San Francisco, United States, San Francisco, United States, San Francisco, United States.
Who is sponsoring the NCT05572632 clinical trial?
NCT05572632 is sponsored by University of California, San Francisco. The principal investigator is Neeta Thakur, MD, MPH at University of California, San Francisco. The trial plans to enroll 387 participants.
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