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

NCT05572632 | Recruiting DMC

• 2 other identifiers: 21-35495R01HL161049
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 3

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Social Needs; Chronic Disease; Health Disparities; Lung Diseases; Community Resources

Outcome Measures

Primary Outcomes (1)

• Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit

  Standardized validated test to measure distance walked in 6 minutes

  3-month (End of intervention) visit

Secondary Outcomes (8)

• 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

• 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

• 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

• Intervention Adherence at End-of-intervention (3 month)

  Assessed during 10-week COPD Wellness Intervention

• 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

Other Outcomes (6)

• Change from Baseline Hospital Anxiety and Depression (HAD) Score 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

• Change from Baseline Smoking Status 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

• Change from Baseline Social Needs Screening 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

Study Arms (3)

COPD Wellness

EXPERIMENTAL

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.

Behavioral: COPD Wellness

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

COPD Wellness Plus+

EXPERIMENTAL

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.

Behavioral: COPD Wellness Plus+

Interventions

COPD Wellness BEHAVIORAL

COPD Wellness consists of 10 weekly sessions led by the COPD Wellness Coach. The intervention was designed to be portable, rely on little equipment, and require limited space (\~300sqft). The curriculum was iteratively developed with patient input and builds behavioral capability and self-efficacy through 30 minutes blocks of disease education and self-management skill building, exercise training, and social support.

COPD Wellness

COPD Wellness Plus+ BEHAVIORAL

Couples COPD Wellness with the ZSFG Health Advocates Program. The HA will help the participant prioritize identified needs and, using an algorithm informed approach to connect the individual to the needed resource, this includes providing referrals to outside social or legal service agencies, help with applications for social benefits, or other services. The HA will use a checklist to track activities including review and prioritization of needs, referrals or resources provided, and contacts/contact attempts.

COPD Wellness Plus+

Usual Care BEHAVIORAL

Includes access to comprehensive primary care services that is standardized across the SFHN. 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. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.

Usual Care

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Willingness to participate in the COPD Wellness program
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Zuckerberg San Francisco General (ZSFG) Hospital

San Francisco, California, 94110, United States

RECRUITING

Maxine Hall Health Center (MHHC)

San Francisco, California, 94115, United States

RECRUITING

Southeast Health Center (SEHC)

San Francisco, California, 94124, United States

RECRUITING

Related Publications (5)

• Troosters T, Gosselink R, Decramer M. Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Am J Med. 2000 Aug 15;109(3):207-12. doi: 10.1016/s0002-9343(00)00472-1.

  PMID: 10974183 BACKGROUND

• Baumann HJ, Kluge S, Rummel K, Klose H, Hennigs JK, Schmoller T, Meyer A. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial. Respir Res. 2012 Sep 27;13(1):86. doi: 10.1186/1465-9921-13-86.

  PMID: 23017153 BACKGROUND

• Selzler AM, Simmonds L, Rodgers WM, Wong EY, Stickland MK. Pulmonary rehabilitation in chronic obstructive pulmonary disease: predictors of program completion and success. COPD. 2012 Aug;9(5):538-45. doi: 10.3109/15412555.2012.705365.

  PMID: 23030585 BACKGROUND

• Fischer MJ, Scharloo M, Abbink JJ, van 't Hul AJ, van Ranst D, Rudolphus A, Weinman J, Rabe KF, Kaptein AA. Drop-out and attendance in pulmonary rehabilitation: the role of clinical and psychosocial variables. Respir Med. 2009 Oct;103(10):1564-71. doi: 10.1016/j.rmed.2008.11.020. Epub 2009 May 29.

  PMID: 19481919 BACKGROUND

• Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.

  PMID: 26623686 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Chronic Disease; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neeta Thakur, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeta Thakur, MD, MPH

CONTACT

628-206-8314; neeta.thakur@ucsf.edu

Valeria M Rojas, BS

CONTACT

408-840-1971; Valeria.rojas@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masked research coordinator will administer questionnaires and conduct clinical assessments at all study visits. Condition assignment will remain masked through data analysis and interpretation from study investigators and any team members involved in the data analysis. Furthermore, the COPD Wellness Coach leading weekly sessions, in addition to the research coordinator collecting endpoint measurements, will be masked to participant group status.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Wait-list randomized controlled trial.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 10, 2022
• Study Start: January 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)