Philly CEAL- DECIDE+ Adaptation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorUniversity of Pennsylvania

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Reside in Philadelphia

Be between 35 and 75 years of age (inclusive)

Pre-diabetes

Diabetes

Disqualifiers

Does not reside in Philadelphia

Not between 35 and 75 years of age (inclusive)

Pre-diabetes

Diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: DECIDE+ Arm with Biweekly Follow-up CallsExperimental treatment 2 interventions
Group B: DECIDE+ Arm with a Monthly Follow-up CallExperimental treatment 2 interventions
Group C: CHW Standard of Care with Biweekly Follow-up CallsActive comparator 1 intervention
Group D: CHW Standard of Care with Monthy Follow-up CallsActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Unmet Social Needs

We will also assess participants' unmet social needs and their appropriate resolution, as measured using an 8-domain social needs inventory. For each social need identified, the degree to which the need has been addressed by a CHW will be assessed by asking participants whether they have discussed this need with a CHW, whether they have received a referral for this need form their CHW, and whether they have followed up on that referral. These follow up questions will be used to create a continuum score ranging from 0-3 for each social need, and a total social needs resolution score will be calculated by dividing the sum of the participants score across identified needs by the total possible score given the number of needs identified to create a scale ranging from 0-1, where higher scores indicate greater resolution of social needs.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Westat

Collaborator

City of Phladelphia - Office of Community Empowerment and Opportunity

Collaborator