Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT05965869
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2023-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Communities Through CHW Initiatives
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 to track the ability to address healthcare access and quality barriers using an online platform.
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. 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. 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=460) in a two phase study, pilot followed by main study. We will assist church members in becoming CHWs, train them in diabetes, and use an online platform 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.
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. 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. 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=460) in a two phase study, pilot followed by main study. We will assist church members in becoming CHWs, train them in diabetes, and use an online platform 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 23-0169 | OTHER | University of Texas Medical Branch, Galveston IRB | View |