RADx-UP- Impact of Community Health Worker Deployment

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05863884
• Other study ID #: 1854646
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Morehouse School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: July 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Albany Area Primary Health Care	Albany	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Morehouse School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	COVID-19 Vaccination Confidence and Uptake	Change in COVID-19 vaccination status and confidence using diabetes self-management questionnaire from week 1 to week 6.	6 weeks
Primary	Blood Glucose Level	Change in HbA1c level from using clinical assessment parameters from week 1 to week 6.	6 weeks
Secondary	Diabetes Self-Management Score	Change in overall diabetes self-management score using diabetes self-management questionnaire from week 1 to week 6.	6 weeks