| NCT ID | NCT06732102 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Disparities |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2027-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-04-14 with a primary completion date of 2027-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility Criteria
Inclusion Criteria: * Reside in Philadelphia * Be between 35 and 75 years of age (inclusive) * Self-report having been told by a healthcare provider that they have one or more of the following CVD-related chronic conditions: 1. Pre-diabetes 2. Diabetes 3. Hypertension 4. Hyperlipidemia/ high cholesterol) 5. BMI \>=30. * Have completed an initial visit with a CEO CHW * Have one or more unmet social needs identified in the CEO Intake Form in the following areas: 1. Housing Stability, 2. Food security, 3. Transportation to medical appointments and/or work, 4. Employment, 5. Household utilities, 6. Healthcare access, 7. Health literacy, and 8. Social support. * Willing to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment. Exclusion Criteria: * Does not reside in Philadelphia * Not between 35 and 75 years of age (inclusive) * Does not self-report having been told by a healthcare provider that they have one or more of the following CVD-related chronic conditions: 1. Pre-diabetes 2. Diabetes 3. Hypertension 4. Hyperlipidemia/ high cholesterol) 5. BMI \>=30. * Has not completed an initial visit with a CEO CHW * Does not have one or more unmet social needs identified in the CEO Intake Form in the following areas: 1. Housing Stability, 2. Food security, 3. Transportation to medical appointments and/or work, employment, 4. Household utilities, 5. Healthcare access, 6. Health literacy, and 7. Social support. * Unwilling to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment.
Contact & Investigator
Jose Bauermeister, MPH, PhD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06732102 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 75 Years, studying Disparities. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06732102 currently recruiting?
Yes, NCT06732102 is actively recruiting participants. Contact the research team at phillyceal@nursing.upenn.edu for enrollment information.
Where is the NCT06732102 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06732102 clinical trial?
NCT06732102 is sponsored by University of Pennsylvania. The principal investigator is Jose Bauermeister, MPH, PhD at University of Pennsylvania. The trial plans to enroll 500 participants.