Rehabilitation for Patients With COPD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: COPD Wellness
* Behavioral: Health Advocate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A step-wedge design will allow all participants to receive the intervention. Participants not immediately enrolled into the intervention will serve as controls. At the time of the intervention, these participants will move over to the treatment arm. The first two groups will be used to refine the COPD Wellness intervention and identify social barriers specific to individuals living with COPD. Starting with group 3, we will alternate the addition of the Health Advocates (HA) program as an adherence strategy in order to determine the HA's effect on participation in COPD Wellness.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COPD Wellness With Health Advocate<br>This arm will be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD with an additional assignment of a health advocate to address unmet social needs as an adherence strategy. | Behavioral: COPD Wellness<br>* This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.<br>Behavioral: Health Advocate<br>* The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources<br>|
| Active Comparator: COPD Wellness<br>This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD. | Behavioral: COPD Wellness<br>* This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline 6 Minute Walk Test at End of Intervention | Standardized test to measure distance walked in 6 minutes | 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 | End of Intervention, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 months | 
| Change in baseline Smoking status at end of intervention | Have you smoked a cigarette in the past 30 days | 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 | 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 | End of Intervention, an average of 4 months | 
| Change from baseline D-12 evaluation at 12 months | Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms | 12 months | 
| Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention | Diagnoses of depressive disorders and depression severity | End of Intervention, an average of 4 months | 
| Adherence | Number of classes attended by the participant | Assessed during 10-week COPD Wellness Intervention | 
| Change from Baseline 6 Minute Walk Test at 12 months | Standardized test to measure distance walked in 6 minutes | Baseline and 12 months | 
| Change from Baseline COPD Assessment Test (CAT) at 12 months | Measure of COPD symptoms and quality of life | Baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Disparities, Lung Diseases, Self-management, Chronic Disease, Socio-economic status