- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06932549
Engaging Partners in Caring Communities (EPICC)
April 10, 2025 updated by: Tennessee State University
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.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
The recruitment process is designed to provide a team of 3-5 volunteers from 40 congregations with information about five EBPs identified by the research team from which they are to choose one.
The team completes one EPICC Survey for their congregation.
The team is then offered up to 10 months of TA with the expectation that 2-3 months will be used for planning to launch the EBP, with 4-6 months for implementation.
Each congregation will be asked to recruit a minimum of 8-10 members of the congregation to complete a brief report of health behaviors prior to launching of the EBP and repeating that report 6 months later to assess the impact of the EBP on their health behaviors.
Study Type
Observational
Enrollment (Estimated)
320
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37209
- Tennessee State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-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.
Description
Inclusion Criteria: Adult (18 years and older) participants in the behavioral intervention (implemented health promotion program) in a congregation in Davidson County that has completed enrollment in the EPICC Project.
Exclusion Criteria:
- Individuals who are not enrolled in a health promotion program implemented in an EPICC congregation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engaging Partners in Caring Communities (EPICC) Survey
Time Frame: Congregational teams complete the EPICC Survey at baseline and again 6-10 months later.
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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
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Congregational teams complete the EPICC Survey at baseline and again 6-10 months later.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
My Own Health Report
Time Frame: My Own Health Report will be completed when the congregation launches their health promotion program and again 6 months later.
|
This is a brief self-reported screening of health-related behavior that will be completed in REDCap.
It includes items related to frequency of consumption of fruits, vegetables, and sugary beverages, strenuous exercise, stress, tobacco and alcohol use over the previous 7 days.
There are also items about transportation access, housing and food security.
Each congregation will be asked to recruit 8-10 individuals who intend to participate in some aspect of the EB Program being implemented by the church.
These individuals will be guided to create a unique ID number they can remember so that their reports are anonymous.
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My Own Health Report will be completed when the congregation launches their health promotion program and again 6 months later.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
April 10, 2025
First Submitted That Met QC Criteria
April 10, 2025
First Posted (Actual)
April 17, 2025
Study Record Updates
Last Update Posted (Actual)
April 17, 2025
Last Update Submitted That Met QC Criteria
April 10, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #HS2021-4674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We will discuss this with congregations that enroll in the study.
They will be given the option of allowing or prohibiting sharing of individual data from My Own Health Report.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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