Healthy Communities Through CHW Initiatives

August 25, 2023 updated by: The University of Texas Medical Branch, Galveston

Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative

Latino(a)s suffer from poor social determinants of health (SODH) conditions more than non-minority populations, and being a minority is risk factor alone for diabetes. In the proposed study, investigators will assist church members in becoming Community Health Workers (CHWs), train them in diabetes, and use an online platform (Salesforce) to track the ability to address healthcare access and quality barriers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Social determinants of health (SODH) are environmental variables that determine quality-of-life outcomes and risks that are delineated into five domains. Inequities in SODH are directly associated with diabetes. Latino(a)s suffer from poor SODH conditions more than non-minority populations, and being a minority is risk factor alone for diabetes. To quantify progress in SODH, Healthy People 2030 has provided specific objectives to measure each domain (economic stability, education access and quality, healthcare access and quality, neighborhood and build environment, and social and community context); this application focuses on the healthcare access and quality domain. While there are numerous screening mechanisms to identify SODH conditions, there is a critical need to implement interventions that are translatable into real-world practices.

A successful intervention requires several components. For the community, sites are needed that can bring individuals together, making collaboration with faith-based establishments of particular interest. Religious institutions provide an infrastructure that will persist beyond funding periods and a framework for the community to share a responsibility of health promotion.1 Churches also provide an accessible and familiar setting to provide health outreach programs but often lack trained personnel to conduct initiatives. In addition, training leaders within these settings who can reach the community is essential. Community Health Workers (CHWs) are trusted leaders within their community.2 Training church members to become CHWs potentially establishes a site familiar to the surrounding communities led by trusted individuals who understand the population at hand. Finally, secure avenues to collect and transmit data are needed. Utilizing secure HIPAA-approved technology reduces risks of loss of confidentiality while allowing collection of valuable information that may not have been collected otherwise. Since COVID-19, investigators have increased the use of online platforms, but these modalities must be translatable to personnel with potentially little to no technological experience.

To address gaps in SDOH, the investigators propose a 6-month church-based intervention for Latino(a)s with and at risk for diabetes (n=100). We will assist church members in becoming CHWs, train them in diabetes, and use an online platform (Salesforce) to track the ability to address healthcare access and quality barriers. The research team will provide telementoring to local community teams (church leadership and CHWs) to initiate the intervention. We will test the feasibility of the program using three pre-established areas of focus: acceptability, integration, limited efficacy testing.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555-0158
        • Recruiting
        • University of Texas Medical Branch at Galveston
        • Contact:
          • Erika LeGross
          • Phone Number: 409-266-9400

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

Description

Inclusion Criteria:

  • Spanish-speaking Latino(a)s adults

Exclusion Criteria:

  • pregnant state or anticipated state in the next 6 months
  • Type 1 diabetes diagnosis
  • Not Spanish-speaking, and
  • Self-disclosed diagnosis of schizophrenia, psychotic/delusional disorder, or severe Alzheimer's disease.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes program and education
Receive diabetes program and education
Other: diabetes program
CHWs will contact participants weekly via phone or text, send bimonthly diabetes education videos, and provide optional monthly seminars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the integration of the intervention
Time Frame: 6-months
CHW ability to use software as measured by the number of anticipated vs. actual documents uploaded at 6-months
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the limited efficacy of the intervention
Time Frame: 6-months
Participant knowledge as measured by the % correct on a pretest vs. posttest, CHW ability to use Salesforce to track and address unmet Healthy People 2030 healthcare access objectives, CHW ability to use Salesforce to track and address newly identified healthcare access barriers. The latter two will be measured by a continuous outcome, from 0 to x. We will also measure if there were missed opportunities and the percentage identified vs. percentage of those missed.
6-months
Provide acceptability data of the intervention
Time Frame: 6-months

Site, CHW, and participant survey data at 6-months as measured on a Likert scale, e.g., Likert scale from 1 to 5 where 1 is unsatisfied and 5 is very satisfied.

Participant participation trends in the intervention
6-months

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

Baylor College of Medicine
University of Houston

Investigators

  • Principal Investigator: Elizabeth Vaughan, DO, University of Texas medical branch, Galveston

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.

General Publications

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 (Actual)

August 1, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0169 (Other Identifier: University of Texas Medical Branch, Galveston IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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