Improving outcomes for vulnerable COPD patients through a wellness program
Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD
NA · University of California, San Francisco · NCT05572632
This study is testing a 10-week wellness program for people with COPD in underserved communities to see if it helps them feel better compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 387 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 3 sites (San Francisco, California and 2 other locations) |
| Trial ID | NCT05572632 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a 10-week COPD Wellness and Plus+ Program compared to usual care for patients with chronic obstructive pulmonary disease (COPD) in underserved communities. It incorporates a Health Advocates program to address social needs and barriers to healthcare, aiming to improve functional and symptom outcomes. The trial is designed as a three-arm, randomized waitlist-controlled study conducted in urban primary care sites that serve socially vulnerable populations. The implementation of the program will be assessed using established frameworks to identify barriers and enablers to patient acceptance and adherence.
Who should consider this trial
Good fit: Ideal candidates are English or Spanish speaking adults aged 40 to 90 with physician-diagnosed COPD and specific spirometry-confirmed criteria.
Not a fit: Patients with unstable cardiovascular disease, cognitive impairments, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the health outcomes and quality of life for patients with COPD in low socioeconomic communities.
How similar studies have performed: Previous studies have shown promise in similar interventions aimed at improving COPD outcomes in underserved populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 2 other locations
- Zuckerberg San Francisco General (ZSFG) Hospital — San Francisco, California, United States (RECRUITING)
- Maxine Hall Health Center (MHHC) — San Francisco, California, United States (RECRUITING)
- Southeast Health Center (SEHC) — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Neeta Thakur, MD, MPH — University of California, San Francisco
- Study coordinator: Neeta Thakur, MD, MPH
- Email: neeta.thakur@ucsf.edu
- Phone: 628-206-8314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COPD, Social Needs, Chronic Disease, Health Disparities, Lung Diseases, Community Resources