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Philly CEAL- DECIDE+ Adaptation
NCT06732102 · View on ClinicalTrials.gov ↗
Study 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 interventi
Conditions Studied
Interventions
- BEHAVIORAL DECIDE
- BEHAVIORAL Community Health Worker Support
Study Locations (1)
Pennsylvania
- University of Pennsylvania — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-04-14 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06732102
The ClinicalTrials.gov registry entry for NCT06732102 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 2 interventions — of which DECIDE is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06732102 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06732102 about?
NCT06732102 is a clinical study titled "Philly CEAL- DECIDE+ Adaptation". 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 s...
What is the current status of trial NCT06732102?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2025-04-14. Estimated completion is 2028-03-31.
What conditions does trial NCT06732102 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Social Determinants of Health (SDOH), Community Health Workers, Disparities. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06732102?
The interventions under investigation include: DECIDE (BEHAVIORAL), Community Health Worker Support (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06732102?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06732102 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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