Rehabilitation for Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Behavioral: COPD WellnessBehavioral: Health Advocate
- Registration Number
- NCT03287440
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description COPD Wellness COPD Wellness This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD. COPD Wellness With Health Advocate COPD Wellness 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. COPD Wellness With Health Advocate 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.
- Primary Outcome Measures
Name Time Method Change from Baseline 6 Minute Walk Test at End of Intervention End of Intervention, an average of 4 months Standardized test to measure distance walked in 6 minutes
Change from Baseline COPD Assessment Test (CAT) at End of Intervention End of Intervention, an average of 4 months Questionnaire assessing COPD symptoms and quality of life
- Secondary Outcome Measures
Name Time Method Change from baseline D-12 evaluation at end of intervention End of Intervention, an average of 4 months Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention End of Intervention, an average of 4 months Diagnoses of depressive disorders and depression severity
Adherence Assessed during 10-week COPD Wellness Intervention Number of classes attended by the participant
Change in baseline Smoking status at end of intervention End of Intervention, an average of 4 months Have you smoked a cigarette in the past 30 days
Change from Baseline 6 Minute Walk Test at 12 months Baseline and 12 months Standardized test to measure distance walked in 6 minutes
Change from Baseline number of exacerbations of COPD at End of Intervention End of Intervention, an average of 4 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
Change from Baseline number of exacerbations of COPD at 12 months 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
Change from Baseline COPD Assessment Test (CAT) at 12 months Baseline, 12 months Measure of COPD symptoms and quality of life
Change in baseline Smoking status at 12 months 12 months Have you smoked a cigarette in the past 30 days
Change from baseline D-12 evaluation at 12 months 12 months Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
Trial Locations
- Locations (1)
Zuckerberg San Francisco General Hospital and Trauma Center
🇺🇸San Francisco, California, United States