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Clinical Trials/NCT05863884
NCT05863884CompletedNot Applicable

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 enrollmentStarted: February 11, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
87
Locations
1
Primary Endpoint
Blood Glucose Level

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

CHW Intervention

Other

A six week CHW home-visit behavioral intervention examining changes in diabetes outcomes.

Intervention: Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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