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Clinical Trials/NCT05863884
NCT05863884
Completed
N/A

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

Morehouse School of Medicine1 site in 1 country87 target enrollmentFebruary 11, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
Morehouse School of Medicine
Enrollment
87
Locations
1
Primary Endpoint
Blood Glucose Level
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2022
End Date
April 30, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Blood Glucose Level

Time Frame: 6 weeks

Change in HbA1c level from using clinical assessment parameters from week 1 to week 6.

Secondary Outcomes

  • Diabetes Self-Management Score(6 weeks)

Study Sites (1)

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