RADx-UP- Impact of Community Health Worker Deployment

Sponsor
Morehouse School of Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05863884
Collaborator
(none)
100
1
1
17.6
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
RADx-UP- Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake
Actual Study Start Date :
Feb 11, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: CHW Intervention

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
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.

Outcome Measures

Primary Outcome Measures

  1. Blood Glucose Level [6 weeks]

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

Secondary Outcome Measures

  1. Diabetes Self-Management Score [6 weeks]

    Change in overall diabetes self-management score using diabetes self-management questionnaire from week 1 to week 6.

Other Outcome Measures

  1. COVID-19 Vaccination Confidence and Uptake [6 weeks]

    Change in COVID-19 vaccination status and confidence using diabetes self-management questionnaire from week 1 to week 6.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Albany Area Primary Health Care Albany Georgia United States 31707

Sponsors and Collaborators

  • Morehouse School of Medicine

Investigators

  • Principal Investigator: Rakale C Quarells, PhD, Morehouse School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Morehouse School of Medicine
ClinicalTrials.gov Identifier:
NCT05863884
Other Study ID Numbers:
  • 1854646
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Morehouse School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2023