Rehabilitation for Patients With COPD

University of California, San Francisco39 enrolled

Overview

This study will examine COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group and home exercise, education, and social support can improve symptoms and increase physical activity in participants with COPD who receive care within a 'safety-net' healthcare system (e.g. County Hospital). Half of the participants will also receive an adherence strategy targeted at addressing unmet social needs, while the other half will undergo the intervention without the adherence strategy.

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. COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group and home exercise, education, and social support, was developed to address this gap. This intervention is targeted at patients with moderate to severe COPD (GOLD Class B-D) who receive care through a safety-net health system. To be impactful, risk factors for low adherence include both disease severity and socio-environmental factors, must be addressed. As merely having a pulmonary rehabilitation program will not automatically lead to improved outcomes. As part of this study, an adherence strategy targeted at addressing unmet social needs to improve health will also be implemented. A Health Advocates program that links social needs screening with a tiered referral and linkage process to appropriate resources will be tested to see if adherence to COPD Wellness (exercise intervention) improves by addressing competing non-medical stressors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

COPD WellnessBEHAVIORAL

This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.

Health AdvocateBEHAVIORAL

The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources

Eligibility

Sex: ALLMin age: 40 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age: Are greater than or equal to 40 years * Diagnosis: COPD Gold Stage Class B-D (symptomatic disease), COPD/Asthma overlap with symptoms * Language: English * Care Center: ZSFG, Community Health Center clinics, Federally Qualified Health Centers * Availability: Able to participate in a 10-week, weekly course at the weekly scheduled time (can defer x 1) Exclusion Criteria: * Planning to move out of the area within the next year * Eligible for and desire to go to full intensity pulmonary rehabilitation. Participant has Medicare Part A and B OR have San Francisco Health Plan. For those that met these criteria, we will assist with referral to program * Resides in any kind of long-term care facilities that is NOT Laguna Honda or the Mental Health Rehabilitation Facility * Has a diagnosis of interstitial lung disease, pulmonary fibrosis, or cystic fibrosis * Active, chronic lung infection, such as tuberculosis * A history of a pulmonary embolism in the year (12 months) prior to recruitment * History of a myocardial infarction in the year (12 months) prior to recruitment * In the 12 weeks prior to recruitment, has had history of unstable heart disease (including valve disease), heart failure, or uncontrolled irregular heart beat Potential participants who have had the following will be re-assess for eligibility 6 weeks after the initial assessment: * A pulmonary exacerbation or worsening of COPD/Asthma symptoms in the past 6 weeks * History of an upper respiratory infection in the past 6 weeks * History of an eye, chest, or abdominal surgery within the past 6 weeks

Locations (1)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Change from Baseline 6 Minute Walk Test at End of Intervention

Standardized test to measure distance walked in 6 minutes

Time frame: End of Intervention, an average of 4 months

Change from Baseline COPD Assessment Test (CAT) at End of Intervention

Questionnaire assessing COPD symptoms and quality of life

Time frame: End of Intervention, an average of 4 months

Secondary Outcomes

Change from Baseline number of exacerbations of COPD at End of Intervention

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

Time frame: End of Intervention, an average of 4 months

Change from Baseline number of exacerbations of COPD at 12 months

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

Time frame: 12 months

Change in baseline Smoking status at end of intervention

Have you smoked a cigarette in the past 30 days

Time frame: End of Intervention, an average of 4 months

Change in baseline Smoking status at 12 months

Have you smoked a cigarette in the past 30 days

Time frame: 12 months

Change from baseline D-12 evaluation at end of intervention

Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms

Data from ClinicalTrials.gov

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