search
Back to results

RADx-UP- Impact of Community Health Worker Deployment

Primary Purpose

Diabetes, COVID-19, Community Health Workers

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake
Sponsored by
Morehouse School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring diabetes, COVID-19, rural communities, rural health center, rural population, community health workers

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Albany Area Primary Health CareRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CHW Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2022
Last Updated
August 3, 2023
Sponsor
Morehouse School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05863884
Brief Title
RADx-UP- Impact of Community Health Worker Deployment
Official Title
RADx-UP- Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morehouse School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, COVID-19, Community Health Workers, Health Behavior, Health Knowledge, Attitudes, Practice
Keywords
diabetes, COVID-19, rural communities, rural health center, rural population, community health workers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHW Intervention
Arm Type
Other
Arm Description
A six week CHW home-visit behavioral intervention examining changes in diabetes outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Glucose Level
Description
Change in HbA1c level from using clinical assessment parameters from week 1 to week 6.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Diabetes Self-Management Score
Description
Change in overall diabetes self-management score using diabetes self-management questionnaire from week 1 to week 6.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
COVID-19 Vaccination Confidence and Uptake
Description
Change in COVID-19 vaccination status and confidence using diabetes self-management questionnaire from week 1 to week 6.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asia K Rivers, MPH
Phone
404-752-1610
Email
arivers@msm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rakale C Quarells, PhD
Phone
404-752-1956
Email
rquarells@msm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakale C Quarells, PhD
Organizational Affiliation
Morehouse School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Area Primary Health Care
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelley Spires
Phone
229-888-6559
Email
shelley.spires@aaphc.org
First Name & Middle Initial & Last Name & Degree
Lisa Rathel
Phone
229-405-6215
Email
lisa.rathel@aaphc.org
First Name & Middle Initial & Last Name & Degree
Rakale C Quarells

12. IPD Sharing Statement

Learn more about this trial

RADx-UP- Impact of Community Health Worker Deployment

We'll reach out to this number within 24 hrs