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

Not Applicable

Recruiting

• Conditions: COPD (Chronic Obstructive Pulmonary Disease)

• Registration Number: NCT05572632
• Lead Sponsor: University of California, San Francisco

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-10
• Study Start: 2023-01-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 387

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit	3-month (End of intervention) visit	Standardized validated test to measure distance walked in 6 minutes

Secondary Outcome Measures

Name	Time	Method
Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention	Baseline, 6-month, and 9-month visit following end-of-intervention	Standardized validated test to examine functional status and measure distance walked in 6 minutes (reported in meters)
Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit	Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit	Standardized validated comprehensive measure COPD Assessment Test (CAT) of symptom burden for individuals with COPD, minimum score: 0 - maximum score: 40, higher score indicates a more symptomatic COPD
Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit	Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit	Health related quality of life is assessed using the validated Short-Form Chronic Respiratory Disease Questionnaire (SF-CRQ). This includes questions about four domains: dyspnea, fatigue, emotional function, and mastery. Items are answered using a 7-point scale Likert scale and summed within each domain. Higher results indicate a higher health-related quality of life.
Health System Adoption of intervention for patients referred	Baseline, 24-months after study implementation	Proportion of de novo referrals from primary care/post-hospitalization versus prompted referrals from research coordinator
Intervention Adherence at End-of-intervention (3 month)	Assessed during 10-week COPD Wellness Intervention	Adherence as defined by the proportion of sessions attended out of ten
Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up	Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit	Self-report non-standardized questionnaire on COPD exacerbation episodes; Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms; not scored, higher exacerbations indicate more symptomatic COPD
Health System Proportion of patients referred to the intervention	Baseline, 24-months after study implementation	Proportion of patients referred who enroll and participate in the study, which refers to the percent of patients referred that accept (attend 1+ session) COPD Wellness and Plus+ (intervention reach)
Healthy System Maintenance of intervention from start of study to end of study activities	Baseline, Year 3 of study period (end of study activities)	Referral pattern at start vs. at end of study period; staff and leadership intension to continue COPD Wellness and Plus+

Trial Locations

Locations (3)

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