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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Behavioral: COPD Wellness Plus+; Behavioral: Usual Care; Behavioral: COPD Wellness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05572632

R01HL161049 (U.S. NIH Grant/Contract)

21-35495

Details and patient eligibility

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.

Full description

The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.

Enrollment: 387 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

387 participants in 3 patient groups

COPD Wellness

Experimental group

Description:

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.

Treatment:

Behavioral: COPD Wellness

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care

COPD Wellness Plus+

Experimental group

Description:

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.

Treatment:

Behavioral: COPD Wellness Plus+