An interventional study of COPD Wellness and Health Advocate in Chronic Obstructive Pulmonary Disease, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
Exclusion Criteria:
Potential participants who have had the following will be re-assess for eligibility 6 weeks after the initial assessment:
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 · Behavioral: Health Advocate
This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.
Behavioral: COPD Wellness
This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.
The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources
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
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
Time frame: 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
Time frame: 12 months
Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention
Diagnoses of depressive disorders and depression severity
Time frame: End of Intervention, an average of 4 months
Adherence
Number of classes attended by the participant
Time frame: 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
Time frame: Baseline and 12 months
Change from Baseline COPD Assessment Test (CAT) at 12 months
Measure of COPD symptoms and quality of life
Time frame: Baseline, 12 months
Plan to share: No
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco