RADx-UP- Impact of Community Health Worker Deployment

Not Applicable

Active, not recruiting

• Conditions: Health Behavior; Community Health Workers; COVID-19; Diabetes; Health Knowledge, Attitudes, Practice
• Interventions: Behavioral: Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake

• Registration Number: NCT05863884
• Lead Sponsor: Morehouse School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-11
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-18
• Primary Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 87

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHW Intervention	Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake	A six week CHW home-visit behavioral intervention examining changes in diabetes outcomes.

Primary Outcome Measures

Name	Time	Method
Blood Glucose Level	6 weeks	Change in HbA1c level from using clinical assessment parameters from week 1 to week 6.

Secondary Outcome Measures

Name	Time	Method
Diabetes Self-Management Score	6 weeks	Change in overall diabetes self-management score using diabetes self-management questionnaire from week 1 to week 6.

Trial Locations

Locations (1)

Albany Area Primary Health Care; 🇺🇸 Albany, Georgia, United States