RECRUITING

Philly CEAL- DECIDE+ Adaptation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2025-04-14
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06732102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Reside in Philadelphia
  2. * Be between 35 and 75 years of age (inclusive)
  3. * Self-report having been told by a healthcare provider that they have one or more of the following CVD-related chronic conditions:
  4. 1. Pre-diabetes
  5. 2. Diabetes
  6. 3. Hypertension
  7. 4. Hyperlipidemia/ high cholesterol)
  8. 5. BMI \>=30.
  9. * Have completed an initial visit with a CEO CHW
  10. * Have one or more unmet social needs identified in the CEO Intake Form in the following areas:
  11. 1. Housing Stability,
  12. 2. Food security,
  13. 3. Transportation to medical appointments and/or work, employment,
  14. 4. Household utilities,
  15. 5. Healthcare access,
  16. 6. Health literacy, and
  17. 7. Social support.
  18. * Willing to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment.
  1. * Does not reside in Philadelphia
  2. * Not between 35 and 75 years of age (inclusive)
  3. * Does not self-report having been told by a healthcare provider that they have one or more of the following CVD-related chronic conditions:
  4. 1. Pre-diabetes
  5. 2. Diabetes
  6. 3. Hypertension
  7. 4. Hyperlipidemia/ high cholesterol)
  8. 5. BMI \>=30.
  9. * Has not completed an initial visit with a CEO CHW
  10. * Does not have one or more unmet social needs identified in the CEO Intake Form in the following areas:
  11. 1. Housing Stability,
  12. 2. Food security,
  13. 3. Transportation to medical appointments and/or work, employment,
  14. 4. Household utilities,
  15. 5. Healthcare access,
  16. 6. Health literacy, and
  17. 7. Social support.
  18. * Unwilling to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment.

Contacts and Locations

Study Contact

Jose Bauermeister, MPH, PhD
CONTACT
215-898-9993
phillyceal@nursing.upenn.edu
Gladys Thomas, MBA
CONTACT
glthomas@nursing.upenn.edu

Principal Investigator

Jose Bauermeister, MPH, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Antonia Villarruel, RN, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Carmen Alvarez, RN, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Stephen Bonett, RN, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Ashley Clemmons
PRINCIPAL_INVESTIGATOR
Office of Community Empowerment and Opportunity

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Jose Bauermeister, MPH, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Antonia Villarruel, RN, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Carmen Alvarez, RN, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Stephen Bonett, RN, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Ashley Clemmons, PRINCIPAL_INVESTIGATOR, Office of Community Empowerment and Opportunity

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2025-04-14
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • Community Health Worker
  • Chronic Disease Management
  • Cardiovascular Health
  • Unmet social needs

Additional Relevant MeSH Terms

  • Disparities
  • Community Health Workers
  • Cardiovascular Diseases
  • Social Determinants of Health (SDOH)