Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
All Genders
Healthy Volunteers
ID06732102

PhillyCEAL: Addressing Disparities in Chronic Disease Self-management Through an Enhanced Community Health Worker Program

Led by University of Pennsylvania · Updated on 2025-10-01

500

Participants Needed

1

Research Sites

15 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) affects racial and ethnic minority groups and underserved populations in Philadelphia more than others. This research evaluates an enhanced community health worker (CHW) program combining the DECIDE self-management intervention with structured CHW consultations. The goal is to improve CVD self-management skills and address social needs among 500 Philadelphia residents aged 35 to 75 who have CVD risk factors and unmet social needs. The study uses a Type 1 Hybrid Effectiveness-Implementation Design to compare outcomes and understand factors influencing participation and CHW experiences. Participants are randomly assigned to receive either the DECIDE+ intervention or continue with standard CHW services. The DECIDE program consists of nine bi-weekly group sessions focused on education and problem-solving to support behavior changes for better chronic disease management. Those in the DECIDE+ group also receive CHW follow-up calls either biweekly or monthly. The standard care group receives CHW services and follow-up calls on a biweekly or monthly schedule without the DECIDE sessions. Community advisory council support helps mobilize resources to address social needs. During the study, participants will be assessed on their CVD self-management skills using the Self-care of Chronic Illness Inventory Maintenance scale over six months. Researchers will also track changes in health behaviors and the resolution of social needs. Implementation outcomes include CHW knowledge, attitudes, job satisfaction, and the impact of community advisory council efforts. The study aims to provide evidence on combining self-management programs with CHW services to reduce health disparities and improve cardiovascular health outcomes.

CONDITIONS

Brief Title

Philly CEAL- DECIDE+ Adaptation

Who Can Participate

Age: 35Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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: pre-diabetes, diabetes, hypertension, 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 in areas such as housing stability, food security, transportation, 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
Not Eligible

You will not qualify if you...

  • Do not reside in Philadelphia
  • Not between 35 and 75 years of age (inclusive)
  • Do not self-report having one or more of the specified CVD-related chronic conditions
  • Have not completed an initial visit with a CEO community health worker
  • Do not have any unmet social needs in the specified areas
  • Unwilling to consent to participate or lack regular access to a mobile device

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 months

Participants engage in the DECIDE group-based self-management program facilitated by community health workers, focusing on cardiovascular disease problem solving and self-management skills. Participants also receive community health worker support through follow-up calls to address social needs and support behavior change.

Biweekly or monthly follow-up calls depending on assigned intervention arm, plus group session visits every two weeks for 9 sessions

Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

J

Jose Bauermeister, MPH, PhD

G

Gladys Thomas, MBA

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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