Healthy Communities Through CHW Initiatives

Sponsor
Baylor College of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965869
Collaborator
(none)
200
1
36

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: diabetes program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate the integration of the intervention [6-months]

    CHW ability to use software as measured by the number of anticipated vs. actual documents uploaded at 6-months

Secondary Outcome Measures

  1. Test the limited efficacy of the intervention [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.

  2. Provide acceptability data of the intervention [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Baylor College of Medicine

Investigators

  • Principal Investigator: Elizabeth Vaughan, DO, University of Texas Medical Branch, Galveston

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elizabeth Vaughan, Associate Professor, The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT05965869
Other Study ID Numbers:
  • 23-0169
  • 23-0169
First Posted:
Jul 28, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023