Philly CEAL- DECIDE+ Adaptation

NCT06732102 | Recruiting

• 1 other identifier: 856216
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.Is the DECIDE intervention with CHW consultations (DECIDE+) effective in improving CVD self-management skills compared to the standard and limited CHW engagement?
2. 2.Do DECIDE+ sessions improve CVD self-management skills by strengthening problem solving and self-efficacy?
3. 3.Does participation in CHW consultations improve CVD self-management skills by meeting social needs?
4. 4.What key sociodemographic and psychosocial factors influence client participation in the study?
5. 5.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?
6. 6.How does the CAC facilitate resource mobilization to enhance access to services that address social needs in Philadelphia's communities?

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CVD Self-Management Skills

  CVD self-management skills, measured by the Self-care of Chronic Illness Inventory Maintenance scale (SC-CII Maintenance).(Riegel et al., 2018) This 8-item measure of self-care maintenance assesses the degree to which an individual with chronic illness uses various strategies to maintain physical and emotional stability and includes both health promoting behaviors and illness-related behaviors. The scale is scored by summing the responses on the eight items and dividing by the total possible points to create a scale ranging from 0-1, where higher scores indicate better self-care maintenance.

  From enrollment to the end of follow-up period at 6 months

Secondary Outcomes (1)

• Unmet Social Needs

  From enrollment to the end of follow-up at 6 months

Study Arms (4)

DECIDE+ Arm with Biweekly Follow-up Calls

EXPERIMENTAL

We will offer the DECIDE intervention as a group-based program. This program, facilitated by CHWs, will emphasize the importance of observational learning and group support to strengthen their CVD problem solving. Consistent with the DECIDE intervention's existing evidence-base, CVD problem solving is hypothesized to strengthen an individual's CVD self-management self-efficacy and skills, respectively. Increased self-management self-efficacy and skills are posited to increase the adoption of CVD-related health promotive behaviors. Participants in this arm will also receive 2 follow-up calls per month from their assigned CHW.

Behavioral: DECIDE; Behavioral: Community Health Worker Support

DECIDE+ Arm with a Monthly Follow-up Call

EXPERIMENTAL

We will offer the DECIDE intervention as a group-based program. This program, facilitated by CHWs, will emphasize the importance of observational learning and group support to strengthen their CVD problem solving. Consistent with the DECIDE intervention's existing evidence-base, CVD problem solving is hypothesized to strengthen an individual's CVD self-management self-efficacy and skills, respectively. Increased self-management self-efficacy and skills are posited to increase the adoption of CVD-related health promotive behaviors. Participants in this arm will also receive 1 follow-up call per month from their assigned CHW.

Behavioral: DECIDE; Behavioral: Community Health Worker Support

CHW Standard of Care with Biweekly Follow-up Calls

ACTIVE COMPARATOR

CHWs currently serve Philadelphia residents by offering a wide range of personalized services aimed at improving their well-being. CHWs act as a crucial link between communities and healthcare providers, helping residents navigate the healthcare system. By offering guidance and social assistance, they improve community members' ability to communicate effectively with healthcare professionals. They also deliver health education that is culturally and linguistically appropriate, advocate for the health of individuals and communities, coordinate care through referrals and follow-up services, and assist eligible individuals in enrolling in federal, state, local, or nonprofit health and human services programs. Participants in this arm will receive a biweekly CHW Follow-up call.

Behavioral: Community Health Worker Support

CHW Standard of Care with Monthy Follow-up Calls

ACTIVE COMPARATOR

CHWs currently serve Philadelphia residents by offering a wide range of personalized services aimed at improving their well-being. CHWs act as a crucial link between communities and healthcare providers, helping residents navigate the healthcare system. By offering guidance and social assistance, they improve community members' ability to communicate effectively with healthcare professionals. They also deliver health education that is culturally and linguistically appropriate, advocate for the health of individuals and communities, coordinate care through referrals and follow-up services, and assist eligible individuals in enrolling in federal, state, local, or nonprofit health and human services programs. Participants in this arm will receive a Monthly CHW Follow-up call.

Behavioral: Community Health Worker Support

Interventions

DECIDE BEHAVIORAL

Decision-making Education for Choices In Diabetes Everyday (DECIDE) is a self-management program in which education and problem-solving training are utilized to promote behavior change for optimal clinical outcomes.

DECIDE+ Arm with Biweekly Follow-up Calls; DECIDE+ Arm with a Monthly Follow-up Call

Community Health Worker Support BEHAVIORAL

CHWs are expected to actively equip individuals and communities by enhancing health knowledge and promoting self-sufficiency through various activities such as outreach, community education, informal counseling, social support, and advocacy. They act as a crucial link between communities and healthcare providers, helping residents navigate the healthcare system. By offering guidance and social assistance, they improve community members' ability to communicate effectively with healthcare professionals. They also deliver health education that is culturally and linguistically appropriate, advocate for the health of individuals and communities, coordinate care through referrals and follow-up services, and assist eligible individuals in enrolling in federal, state, local, or nonprofit health and human services programs.

CHW Standard of Care with Biweekly Follow-up Calls; CHW Standard of Care with Monthy Follow-up Calls; DECIDE+ Arm with Biweekly Follow-up Calls; DECIDE+ Arm with a Monthly Follow-up Call

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hyperlipidemia/ high cholesterol)
• 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:
• Housing Stability,
• Food security,
• Transportation to medical appointments and/or work,
• Employment,
• Household utilities,

You may not qualify if:

• 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:
• Pre-diabetes
• Diabetes
• Hypertension
• Hyperlipidemia/ high cholesterol)
• 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:
• Housing Stability,
• Food security,
• Transportation to medical appointments and/or work, employment,
• Household utilities,
• Healthcare access,

Sponsors & Collaborators

• University of Pennsylvania: lead
• Westat: collaborator
• City of Phladelphia - Office of Community Empowerment and Opportunity: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Links

• Study Website

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Jose Bauermeister, MPH, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Antonia Villarruel, RN, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Carmen Alvarez, RN, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Stephen Bonett, RN, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Ashley Clemmons

  Office of Community Empowerment and Opportunity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Bauermeister, MPH, PhD

CONTACT

215-898-9993; phillyceal@nursing.upenn.edu

Gladys Thomas, MBA

CONTACT

glthomas@nursing.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants can choose whether they wish to participate in the DECIDE group sessions or engage in traditional CHW services, yet they will be randomized to receive either one or two calls per month from their designated community health worker. A 1:1 randomization process will be employed, whereby each individual is assigned a random number generated by a computer algorithm. Participants with an even number will be allocated to receive one call per month (the current standard of care), while those assigned an odd number will receive two calls per month. This random assignment ensures an equal probability of assignment to each group, minimizing selection bias and supporting balanced distribution across the study conditions participation in the DECIDE intervention vs no DECIDE sessions. Participants will be blinded to their assigned call schedule and will be notified at the end of the trial as part of the dissemination of study results.

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 3 years after the publication of results.
• Access Criteria: Data will be findable through the CEAL Repository database that has been established. The study will be assigned a digital object identifier (DOI). We will assure the timely release and sharing of data no later than the acceptance for publication of the main findings from the final dataset and will protect the rights and privacy of human subjects who participate in sponsored research by redacting all identifiers, and adopting other strategies to minimize risks of unauthorized disclosure of personal identifiers.

Locations

US (1)