Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110, United States
NCT Number: NCT03287440
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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Notify Me40 year–95 year
All sexes
Interventional
Not applicable
San Francisco, California, 94110, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Potential participants who have had the following will be re-assess for eligibility 6 weeks after the initial assessment:
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
Time frame: End of Intervention, an average of 4 months
Standardized test to measure distance walked in 6 minutes
Time frame: End of Intervention, an average of 4 months
Questionnaire assessing COPD symptoms and quality of life
Time frame: 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
Time frame: 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: End of Intervention, an average of 4 months
Have you smoked a cigarette in the past 30 days
Time frame: 12 months
Have you smoked a cigarette in the past 30 days
Time frame: End of Intervention, an average of 4 months
Evaluates dyspnea symptoms and increased ease of activities of daily living as related to COPD symptoms
Time frame: 12 months
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
Diagnoses of depressive disorders and depression severity
Time frame: Assessed during 10-week COPD Wellness Intervention
Number of classes attended by the participant
Time frame: Baseline and 12 months
Standardized test to measure distance walked in 6 minutes
Time frame: Baseline, 12 months
Measure of COPD symptoms and quality of life
University of California, San Francisco
Other
Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD
Acronym: COPD Wellness
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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