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RADx-UP- Impact of Community Health Worker Deployment

M

Morehouse School of Medicine

Status

Completed

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05863884
1854646

Details and patient eligibility

About

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.

Enrollment

87 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

87 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Rakale C Quarells, PhD; Asia K Rivers, MPH

Data sourced from clinicaltrials.gov

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