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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Tennessee State University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
My Own Health Report will be completed when the congregation launches their health promotion program and again 6 months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tennessee State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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