NCT06932549

Brief Summary

The goal of the EPICC observational study is to learn about capacity to implement evidence-based health promotion programs (EBPs) in congregations that are offered semi-structured technical assistance (TA). Congregational teams will complete an implementation capacity assessment survey before the TA is offered and 10 months later, after TA has been provided for up to 10 months. Participating congregations will be a convenience sample of congregations in Davidson County, TN that serve primarily African American communities.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

April 10, 2025

Last Update Submit

April 10, 2025

Conditions

Keywords

community-engaged researchhealth equityhealth disparitiesimplementation sciencefaith-based organizations

Outcome Measures

Primary Outcomes (1)

  • Engaging Partners in Caring Communities (EPICC) Survey

    The EPICC Survey was developed using the Consolidated Framework for Implementation Research (CFIR) and building on other surveys for measuring congregational readiness for health promotion. It consists of

    Congregational teams complete the EPICC Survey at baseline and again 6-10 months later.

Secondary Outcomes (1)

  • My Own Health Report

    My Own Health Report will be completed when the congregation launches their health promotion program and again 6 months later.

Study Arms (1)

There will be a single cohort consisting of up to 40 congregations.

The study cohort will consist of up to 40 congregations in Davidson County, TN that that have had a physical location for at least a year, have approval from their leader, and have a tax ID will be eligible for enrollment. Each will be offered up to 10 months of at least 1 hour/month of technical assistance for implementing an evidence-based (EB) chronic disease prevention congregation-level intervention selected by the congregation from five identified by the study team. The study team identified the five EB Programs through a systematic search of federal websites, selecting those programs that address chronic diseases that disproportionately affect African Americans, that can be delivered by non-health care providers in community settings. The selected programs include materials, including facilitator guidance, that are downloadable at no charge

Behavioral: Technical assistance is designed to integrate Expert Recommendations for Implementing Change (ERIC) strategies, and Getting To Outcomes-TA.

Interventions

The TA is tailored to each congregation using the results of the implementation capacity survey completed by the congregation's team and materials from the EB Program selected by the congregation. The TA teams of two research staff are being trained and coached by Dr. Abe Wandersman, lead developer of Getting To Outcomes-TA (GTO-TA). TA sessions are audio-recorded and will be evaluated for fidelity to GTO-TA, and use of specific ERIC strategies.

There will be a single cohort consisting of up to 40 congregations.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Selected congregations are all in Davidson County, TN and self-identify as serving African Americans. The proportion of African Americans considered to be members of the congregation may fluctuate over time and will be estimated by church leaders. Some EB programs are designed to serve families and so there may be individuals participating in EB programs who are minors; however, no data will be obtained from minors.

You may not qualify if:

  • Individuals who are not enrolled in a health promotion program implemented in an EPICC congregation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee State University

Nashville, Tennessee, 37209, United States

Location

Related Links

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

June 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations