RADx-UP- Impact of Community Health Worker Deployment

Study Overview
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Brief Summary
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The proposed project will implement and evaluate a brief Community Health Worker (CHW) intervention through the Albany Area Primary Health Care, a rural Federally Qualified Health Center (FQHC). The primary goal of this study is to maximize effective outreach, education, and communication through CHWs in order to facilitate improved COVID-19 vaccine confidence and uptake in underserved and vulnerable communities. CHWs will be deployed to the homes of adults with increased risk of morbidity and mortality (i.e., African Americans or Latinos with uncontrolled diabetes or prediabetes, age <50 years, and non-COVID-19 vaccinated) in order to educate them about diabetes, COVID-19 and related vaccines. Health assessments, including blood glucose measurement, will be conducted on the indexed patient and offered to all other adult family members in the household (i.e., bubble). Adults with Type 2 diabetes likely live in households with other adults who have or are at increased risk for diabetes (i.e., prediabetes and obesity).1 It is expected that they will also share similar COVID-19 exposure risk. The specific aims are to: 1) Evaluate a community-driven education program to increase and enhance COVID-19 vaccine confidence and uptake in individuals with uncontrolled diabetes and their families (i.e., their bubble) and 2) Evaluate a community-driven education program to improve diabetes self-management behaviors and related outcomes (e.g., blood glucose) in individuals with uncontrolled diabetes in rural, Southwest Georgia.

Official Title
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RADx-UP- Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake

Conditions
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Diabetes, COVID-19, Community Health Workers, Health Behavior, Health Knowledge, Attitudes, Practice

Intervention / Treatment
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* Behavioral: Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be between18 and 50 years Self-identify as African American/Black or Latino English speaking Have received care for uncontrolled diabetes (HbA1c > 9%) or prediabetes diagnosis within one of the AAPHC 27 community sites Unvaccinated for Phase 1 (vaccinated for Phase 2) Exclusion Criteria: Not meeting the Inclusion Criteria Enrolled in the parent RADx-UP Project PEACH study Unable or unwilling to provide informed consent to participate in the study (ie: incarcerated individuals and children) Individuals with a terminal cancer diagnosis, have chronic kidney disease (stage 4-5), pregnant women, and people with severe psychological disorders (i.e., dementia,suicide ideation)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CHW Intervention<br>A six week CHW home-visit behavioral intervention examining changes in diabetes outcomes. | Behavioral: Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake<br>* CHWs will conduct home visits to provide diabetes and COVID-19 health education based on the participant's needs, interests, and clinical health assessment results. All adults in the household will be invited to participate in the health education discussions. At each visit, the CHW will use diabetes management and COVID-19 educational materials to facilitate and inform discussions. CHWs will also make available at-home COVID-19 testing kits with instructions for the patient and their household family members. The discussion of COVID-19 beliefs, perceptions, and related behaviors will be raised during a later visit, i.e., after rapport and trust has been established and if it has not been raised by the participants during the earlier visits. In addition, CHWs will help schedule vaccination and healthcare appointments upon participant's interest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Level | Change in HbA1c level from using clinical assessment parameters from week 1 to week 6. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Self-Management Score | Change in overall diabetes self-management score using diabetes self-management questionnaire from week 1 to week 6. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, COVID-19, rural communities, rural health center, rural population, community health workers