NCT Number: NCT05572632
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.
The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.
Interested in participating?
Request Info40 year–90 year
All sexes
Interventional
Not applicable
Maxine Hall Health Center (MHHC), San Francisco, California, United States
The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
COPD Wellness consists of 10 weekly sessions led by the COPD Wellness Coach. The intervention was designed to be portable, rely on little equipment, and require limited space (~300sqft). The curriculum was iteratively developed with patient input and builds behavioral capability and self-efficacy through 30 minutes blocks of disease education and self-management skill building, exercise training, and social support.
Couples COPD Wellness with the ZSFG Health Advocates Program. The HA will help the participant prioritize identified needs and, using an algorithm informed approach to connect the individual to the needed resource, this includes providing referrals to outside social or legal service agencies, help with applications for social benefits, or other services. The HA will use a checklist to track activities including review and prioritization of needs, referrals or resources provided, and contacts/contact attempts.
Includes access to comprehensive primary care services that is standardized across the SFHN. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.
Time frame: 3-month (End of intervention) visit
Standardized validated test to measure distance walked in 6 minutes
Time frame: Baseline, 6-month, and 9-month visit following end-of-intervention
Standardized validated test to examine functional status and measure distance walked in 6 minutes (reported in meters)
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Standardized validated comprehensive measure COPD Assessment Test (CAT) of symptom burden for individuals with COPD, minimum score: 0 - maximum score: 40, higher score indicates a more symptomatic COPD
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Health related quality of life is assessed using the validated Short-Form Chronic Respiratory Disease Questionnaire (SF-CRQ). This includes questions about four domains: dyspnea, fatigue, emotional function, and mastery. Items are answered using a 7-point scale Likert scale and summed within each domain. Higher results indicate a higher health-related quality of life.
Time frame: Assessed during 10-week COPD Wellness Intervention
Adherence as defined by the proportion of sessions attended out of ten
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Self-report non-standardized questionnaire on COPD exacerbation episodes; 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; not scored, higher exacerbations indicate more symptomatic COPD
Time frame: Baseline, 24-months after study implementation
Proportion of patients referred who enroll and participate in the study, which refers to the percent of patients referred that accept (attend 1+ session) COPD Wellness and Plus+ (intervention reach)
Time frame: Baseline, 24-months after study implementation
Proportion of de novo referrals from primary care/post-hospitalization versus prompted referrals from research coordinator
Time frame: Baseline, Year 3 of study period (end of study activities)
Referral pattern at start vs. at end of study period; staff and leadership intension to continue COPD Wellness and Plus+
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
14-item standardized validated questionnaire titled Hospital Anxiety and Depression Scale (HADS) that includes sub-scales on anxiety and depression-- scores added at the end; minimum: 0 - maximum: 21; 0-7 is considered normal, 8-10 is considered borderline abnormal, 11-21 is considered abnormal
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Current use, duration of use, and pack-years will be assessed using the National Health Interview Survey (NHIS) Section IV Part A (Health Behaviors - Tobacco) questionnaire; standardized and validated; not scored
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Using the Accountable Health Communities (AHC) Health Related Social Needs (HRSN) Screening Tool to assess for food and housing insecurity, transportation issues, and financial strain; standardized and validated; not scored, higher numbers indicate higher social need
Time frame: 3-month (End of intervention) visit, 6-month, and 9-month visit
Step count and accelerometry as measured by FitBit Inspire 2 will be compared between the intervention groups (COPD Wellness & Plus+) and the waitlist control group, and between COPD Wellness and Plus+
Time frame: 3-month (End of intervention) visit, 6-month, and 9-month visit
Resting heart rate and heart rate variability as measured by Fitbit Inspire 2 will be compared between the intervention groups (COPD Wellness & Plus+) and the waitlist control group, and between COPD Wellness and Plus+
Time frame: Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit
Non-standardized validated questionnaire assessing mean number of days in which patient took all doses of controller medications (i.e., inhalers taken daily to prevent flare ups) as prescribed in last 7 days; seeking Electronic Health Record (EHR)-confirmation of healthcare visit (from COPD Exacerbation History) and medication prescription; not scored
Contact information is provided by the study sponsor or research team.
Neeta Thakur, MD, MPH
CONTACT
Valeria M Rojas, BS
CONTACT
University of California, San Francisco
Other
Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD
Acronym: RISE
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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