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NCT05572632 | RECRUITING | COPD (Chronic Obstructive Pulmonary Disease)

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

Condition or disease

COPD (Chronic Obstructive Pulmonary Disease)

Intervention/treatment

COPD Wellness

COPD Wellness Plus+

Usual Care

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 387 participants
Masking : DOUBLE
Masking Description : 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.
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD
Actual Study Start Date : 2023-01-19
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

Location Details

NCT05572632

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How to Participate

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Locations

RECRUITING

United States, California

Zuckerberg San Francisco General (ZSFG) Hospital

San Francisco, California, United States, 94110

RECRUITING

United States, California

Maxine Hall Health Center (MHHC)

San Francisco, California, United States, 94115

RECRUITING

United States, California

Southeast Health Center (SEHC)

San Francisco, California, United States, 94124