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Community Health Worker Education for COVID-19
N/A
Waitlist Available
Led By Rakale C Quarells, PhD
Research Sponsored by Morehouse School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have received care for uncontrolled diabetes (HbA1c > 9%) or prediabetes diagnosis within one of the AAPHC 27 community sites
Participants must be between 18 and 50 years
Must not have
Individuals with chronic kidney disease (stage 4-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will provide CHWs to homes of vulnerable adults with diabetes & prediabetes to educate about diabetes, COVID-19 & vaccines. The goal is to increase vaccine confidence & uptake, and improve diabetes self-management.
Who is the study for?
This trial is for African American or Latino adults under 50 with uncontrolled diabetes or prediabetes, who have not been vaccinated against COVID-19 (for Phase 1) and are patients within the AAPHC community sites. It excludes those with severe psychological disorders, terminal cancer, chronic kidney disease stages 4-5, pregnant women, and individuals unable to consent.
What is being tested?
The study tests a Community Health Worker intervention in rural areas to boost COVID-19 vaccine confidence and uptake among high-risk groups. It also aims to improve diabetes self-management. Participants will receive home visits for education on diabetes and COVID-19 vaccines.
What are the potential side effects?
Since this trial focuses on educational interventions rather than medical treatments or drugs, there are no direct side effects from medications being tested. However, participants may experience discomfort during health assessments like blood glucose measurement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received care for high blood sugar or prediabetes at an AAPHC site.
Select...
I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have advanced chronic kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Glucose Level
Secondary study objectives
Diabetes Self-Management Score
Other study objectives
COVID-19 Vaccination Confidence and Uptake
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CHW InterventionExperimental Treatment1 Intervention
A six week CHW home-visit behavioral intervention examining changes in diabetes outcomes.
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Who is running the clinical trial?
Morehouse School of MedicineLead Sponsor
21 Previous Clinical Trials
16,261 Total Patients Enrolled
Rakale C Quarells, PhDPrincipal InvestigatorMorehouse School of Medicine
1 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received care for high blood sugar or prediabetes at an AAPHC site.You consider yourself to be African American/Black or Latino.I have advanced chronic kidney disease.You have serious mental health issues like severe memory loss or thoughts of hurting yourself.I am between 18 and 50 years old.You have not received the vaccine for Phase 1 (but have been vaccinated for Phase 2).People who have been diagnosed with advanced stage cancer.
Research Study Groups:
This trial has the following groups:- Group 1: CHW Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.