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Healthy Communities Through CHW Initiatives

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diabetes program
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Texas Medical Branch at GalvestonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diabetes program and education

Arm Description

Receive diabetes program and education

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Test the limited efficacy of the intervention
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.
Provide acceptability data of the intervention
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

Full Information

First Posted
July 20, 2023
Last Updated
August 25, 2023
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Baylor College of Medicine, University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05965869
Brief Title
Healthy Communities Through CHW Initiatives
Official Title
Creating Healthy Communities Through a Church-based, Community Health Worker-led Initiative
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Baylor College of Medicine, University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes program and education
Arm Type
Experimental
Arm Description
Receive diabetes program and education
Intervention Type
Other
Intervention Name(s)
diabetes program
Intervention Description
CHWs will contact participants weekly via phone or text, send bimonthly diabetes education videos, and provide optional monthly seminars.
Primary Outcome Measure Information:
Title
Evaluate the integration of the intervention
Description
CHW ability to use software as measured by the number of anticipated vs. actual documents uploaded at 6-months
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Test the limited efficacy of the intervention
Description
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.
Time Frame
6-months
Title
Provide acceptability data of the intervention
Description
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
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Vaughan, DO
Phone
1-409-772-4182
Email
emvaugha@utmb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Vaughan, DO
Organizational Affiliation
University of Texas Medical Branch, Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika LeGross
Phone
409-266-9400

12. IPD Sharing Statement

Plan to Share IPD
No
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Healthy Communities Through CHW Initiatives

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