Recruiting

DECIDE+

Sponsor:

University of Pennsylvania

Code:

NCT06732102

Conditions

Disparities

Community Health Workers

Cardiovascular Diseases

Social Determinants of Health (SDOH)

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

Interventions

DECIDE

Community Health Worker Support

Study Details

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. 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?

Conditions

Disparities

Community Health Workers

Cardiovascular Diseases

Social Determinants of Health (SDOH)

Study ID

NCT06732102

Start date

Apr 14, 2025

Status verified date

Sep, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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:

1. Pre-diabetes
2. Diabetes
3. Hypertension
4. Hyperlipidemia/ high cholesterol)
5. 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:

1. Housing Stability,
2. Food security,
3. Transportation to medical appointments and/or work,
4. Employment,
5. Household utilities,
6. Healthcare access,
7. Health literacy, and
8. Social support.
  • Willing to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment.

Exclusion Criteria:

  • 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:

1. Pre-diabetes
2. Diabetes
3. Hypertension
4. Hyperlipidemia/ high cholesterol)
5. 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:

1. Housing Stability,
2. Food security,
3. Transportation to medical appointments and/or work, employment,
4. Household utilities,
5. Healthcare access,
6. Health literacy, and
7. Social support.
  • Unwilling to consent to participate in the CEAL study regular access to a mobile device to qualify for enrollment.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DECIDE+ Arm with Biweekly Follow-up Calls

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.

experimental: DECIDE+ Arm with a Monthly Follow-up Call

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.

active comparator: CHW Standard of Care with Biweekly Follow-up Calls

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.

active comparator: CHW Standard of Care with Monthy Follow-up Calls

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.

Interventions

DECIDE

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

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.

Primary outcome measure

  • CVD Self-Management Skills [ Time Frame: From enrollment to the end of follow-up period at 6 months ]

Central Contacts and Locations

Central contacts

Jose Bauermeister, MPH, PhD

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

Gladys Thomas, MBA

glthomas@nursing.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-10-01.