Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
Maxine Hall Health Center (MHHC)
RECRUITING
San Francisco
Southeast Health Center (SEHC)
RECRUITING
San Francisco
Zuckerberg San Francisco General (ZSFG) Hospital
RECRUITING
San Francisco
Contact Information
Primary
Neeta Thakur, MD, MPH
neeta.thakur@ucsf.edu
628-206-8314
Backup
Valeria M Rojas, BS
Valeria.rojas@ucsf.edu
408-840-1971
Time Frame
Start Date: 2023-01-19
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 387
Treatments
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.
Sponsors
Leads: University of California, San Francisco
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov