Family Model Diabetes Self-Management Education in Faith Based Organizations

Study Overview
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Brief Summary
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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.

Official Title
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Family Model Diabetes Self-Management Education in Faith Based Organizations

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Family Model Diabetes Self-Management Education and Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family DSMES<br> | Behavioral: Family Model Diabetes Self-Management Education and Support<br>* Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.<br>|
| Experimental: Wait List<br> | Behavioral: Family Model Diabetes Self-Management Education and Support<br>* Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points | 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. | Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Model, Diabetes Education, Marshallese, Pacific Islander