Study Information

dbGaP Study Accession: phs003032

NIH Institute/Center: NIDDK

RADx Data Program: RADx-UP

DOI: 10.60773/9d1x-h432

Release Date: 08/29/2023

Updated Date: 04/17/2024

Study Description: The Georgia Center for Diabetes Translation Research Center (P30DK111024) proposed to collaborate with the RADx-UP Diabetes rural community partner and utilized locally developed and tested Georgia CEAL (1OT2HL156812-01/16-312-0217571-66105L) COVID-19 communication materials to enhance COVID-19 testing in addition to vaccine confidence and uptake in underserved populations most severely affected by COVID-19 disease (i.e., African Americans and Latinos with diabetes, prediabetes, and their household contacts ("bubble). The 1-year project implemented and evaluated 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 was 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 were 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, were 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). It was expected that they would also share similar COVID-19 exposure risk. The specific aims were 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.

Principal Investigator: Quarells, Rakale C

Has Data Files: Yes

Study Domain: Community Outreach Programs; Testing Rate/Uptake; Virological Testing; Pandemic Perceptions and Decision-Making; Vaccination Rate/Uptake

Data Collection Method: Survey; Interview or Focus Group

Keywords: Diabetes; COVID Education; Diabetic Population

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: Emory University; Albany Area Primary Health Care

Data Types: Behavioral; Clinical; Social; Questionnaires/Surveys

Study Start Date: 08/27/2021

Study End Date: 08/01/2023

Species: Human Data

Estimated Cohort Size: 105

Study Population Focus: Racial and Ethnic Minorities; Adults; Rural Communities; Underserved/Vulnerable Population; Hispanic and Latino; African American

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05863884

Publication URL: https://link.springer.com/article/10.1007/s41745-023-00364-x?utm_source=xmol&utm_medium=affiliate&utm_content=meta&utm_campaign=DDCN_1_GL01_metadata; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9675707/

Acknowledgement Statement: This study was supported through funding, 3P30DK111024-06S1, for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as part of the RADx-UP program. We would like to thank the Georgia Diabetes Translation Research Center (GDTRC), Morehouse School of Medicine’s Prevention Research Center (PRC), Albany Area Primary Health Care, Georgia CTSA, Emory Healthcare, Grady Health, and the Georgia Federally Qualified Health Center network. Approved users should acknowledge the provision of data access by dbGaP for accession phs003032.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-272

NIH Grant or Contract Number(s): 3P30DK111024-06S1

Consent/Data Use Limitations: General Research Use

Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs003032_Project S4_Protocol.pdf468.20 KB
READMEprojectS4_README.html281.06 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
projectS4_DATA_transformcopy.csvTabular Data - Harmonizedcsv335
projectS4_DATA_origcopy.csvTabular Data - Non-harmonizedcsv335