Actively Recruiting
Philly CEAL- DECIDE+ Adaptation
Led by University of Pennsylvania · Updated on 2025-10-01
500
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
W
Westat
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cardiovascular disease (CVD) disproportionately affects racial/ethnic minorities and underserved populations in Philadelphia. This study aims to evaluate the effectiveness of an enhanced community health worker (CHW) program that combines the evidence-based DECIDE self-management intervention with structured CHW consultations to improve CVD self-management skills and address social needs. Using a Type 1 Hybrid Effectiveness-Implementation Design, we will recruit 500 Philadelphia residents aged 35-75 with CVD risk factors and unmet social needs. Participants will be offered the DECIDE+ intervention (9 bi-weekly group sessions plus alternating CHW consultations) or continue with standard CHW services. The primary outcome is CVD self-management skills measured by the Self-care of Chronic Illness Inventory Maintenance scale. Secondary outcomes include health behaviors and resolution of social needs. Implementation outcomes will assess CHW experiences, community advisory council impact, and factors influencing participation. Propensity score methods will be used to compare changes in outcomes between DECIDE+ participants and those receiving standard CHW services. Mediation analyses will examine pathways through problem-solving skills, self-efficacy, and social needs resolution. Mixed methods will evaluate implementation outcomes. This study will provide evidence on the effectiveness of integrating an evidence-based self-management program with CHW services to address both clinical and social needs. This study has the potential to generate important and impactful findings that can advance health equity and the science of effective community health worker programs. By rigorously evaluating the real-world implementation of a city-wide CHW-delivered chronic disease self-management program that also addresses collaborative approaches and support to addressing social needs, our findings can provide a roadmap for other communities looking to implement evidence-based interventions to reduce health disparities. Demonstrating improved CVD self-management behaviors and reduced social needs among Philadelphia residents receiving the DECIDE+ intervention would provide compelling evidence for the synergistic benefit of these services, and to sustain and scale up this model. OBJECTIVES: We propose both effectiveness and implementation questions to guide our work: Effectiveness of CHW Engagement: 1. Is the DECIDE intervention with CHW consultations (DECIDE+) effective in improving CVD self-management skills compared to the standard and limited CHW engagement? 1. Do DECIDE+ sessions improve CVD self-management skills by strengthening problem solving and self-efficacy? 2. Does participation in CHW consultations improve CVD self-management skills by meeting social needs? Implementation Questions: 2. What key sociodemographic and psychosocial factors influence client participation in the study? 3. How do CHWs perceive the impact of facilitator training on their a.) knowledge, attitudes and practices in supporting clients b.) personal health management, and c.) job satisfaction? 4. How does the CAC facilitate resource mobilization to enhance access to services that address social needs in Philadelphia's communities?
CONDITIONS
Official Title
Philly CEAL- DECIDE+ Adaptation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Reside in Philadelphia
- Be between 35 and 75 years of age (inclusive)
- Self-report being told by a healthcare provider that they have one or more of the following CVD-related conditions: pre-diabetes, diabetes, hypertension, hyperlipidemia/high cholesterol, or BMI of 30 or higher
- Have completed an initial visit with a CEO community health worker
- Have one or more unmet social needs identified in areas such as housing stability, food security, transportation to medical appointments or work, employment, household utilities, healthcare access, health literacy, or social support
- Willing to consent to participate in the study and have regular access to a mobile device
You will not qualify if you...
- Do not reside in Philadelphia
- Are not between 35 and 75 years of age (inclusive)
- Do not self-report having been told by a healthcare provider that they have any of the specified CVD-related conditions
- Have not completed an initial visit with a CEO community health worker
- Do not have any identified unmet social needs in the specified areas
- Unwilling to consent to participate in the study or do not have regular access to a mobile device
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
J
Jose Bauermeister, MPH, PhD
CONTACT
G
Gladys Thomas, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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