Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
Recruiting · NCT05572632 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
3 locations listed across 1 US state.
- 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