DECIDE + Community Health Worker Support for Cardiovascular Disease

Overseen By Gladys Thomas, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Outside age range, No CVD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 18 weeks

500 Participants Needed

Trial Summary

What is the purpose of 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?

Research Team

Antonia Villarruel, RN, PhD

Principal Investigator

University of Pennsylvania

Jose Bauermeister, MPH, 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

Eligibility Criteria

This trial is for Philadelphia residents aged 35-75 with cardiovascular risk factors like hypertension, pre-diabetes, diabetes, high cholesterol or a BMI of 30 or more. They must have unmet social needs such as housing stability and food security and have seen a CEO CHW.

Inclusion Criteria

I live in Philadelphia.

I am between 35 and 75 years old.

I have been diagnosed with pre-diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DECIDE+ intervention, consisting of 9 bi-weekly group sessions and alternating CHW consultations

18 weeks

9 group sessions (in-person), bi-weekly CHW consultations (virtual or in-person)

Follow-up

Participants are monitored for CVD self-management skills and resolution of social needs

6 months

Treatment Details

Interventions

• Community Health Worker Support
• DECIDE

Trial Overview The study tests an enhanced community health worker program combining DECIDE self-management sessions with regular CHW consultations against standard CHW services to improve cardiovascular disease management in underserved populations.

Participant Groups

Group I: DECIDE+ Arm with a Monthly Follow-up Call Experimental Treatment 2 Interventions

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.

Group II: DECIDE+ Arm with Biweekly Follow-up Calls Experimental Treatment 2 Interventions

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.

Group III: CHW Standard of Care with Biweekly Follow-up Calls Active Control 1 Intervention

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.

Group IV: CHW Standard of Care with Monthy Follow-up Calls Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Westat

Collaborator

Trials

49

Recruited

39,700+

City of Phladelphia - Office of Community Empowerment and Opportunity

Collaborator

Trials

1

Recruited

500+