Rehabilitation for Patients With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-07-30

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.

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The principal investigator and outcome assessor will be masked to when the participant completes the intervention and to whether or not they received the Health Advocates adherence strategy.

Study Groups

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COPD Wellness With Health Advocate

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.

Group Type ACTIVE_COMPARATOR

COPD Wellness

Intervention Type BEHAVIORAL

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

Health Advocate

Intervention Type BEHAVIORAL

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

COPD Wellness

This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.

Group Type ACTIVE_COMPARATOR

COPD Wellness

Intervention Type BEHAVIORAL

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

Interventions

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COPD Wellness

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

Intervention Type BEHAVIORAL

Health Advocate

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No