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Clinical Trials/NCT04256486
NCT04256486
Completed
N/A

Family Model Diabetes Self-Management Education in Faith Based Organizations

University of Arkansas1 site in 1 country321 target enrollmentApril 21, 2022
ConditionsType 2 Diabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Arkansas
Enrollment
321
Locations
1
Primary Endpoint
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.

Registry
clinicaltrials.gov
Start Date
April 21, 2022
End Date
August 22, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • self-reported Marshallese
  • 18 years of age or older
  • have T2D (defined as having an HbA1c equal to or greater than 6.5)
  • have at least one family member willing to take part

Exclusion Criteria

  • has received DSME in the past five years
  • has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
  • plans to move out of the geographic region

Outcomes

Primary Outcomes

Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points

Time Frame: Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention

Measured by Change in Adjusted Mean HbA1c(%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, and 24 Months Post-intervention.

Study Sites (1)

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