Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes

Study Overview
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Brief Summary
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The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with a larger number of adult Haitian immigrants.

Detailed Description
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This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).

Official Title
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Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study

Conditions
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Diabetes Mellitus, Type 2, Patient Engagement, Patient Education

Intervention / Treatment
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* Behavioral: Diabetes Self-Management Behaviors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-described Haitian immigrant aged 21 and older Known diagnosis of type 2 diabetes for at least one year Have lived in the US for at least one year Have an HbA1c of 7.5% Willing and able to participate in an individual interview Exclusion Criteria: Having a diagnosis of type 1 diabetes Unable to comprehend, consent and or fully participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Behavioral: Diabetes Self-management behaviors
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Self-Management Behaviors<br>Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks. | Behavioral: Diabetes Self-Management Behaviors<br>* The intervention is to be delivered by a diabetes educator.<br>|
| No Intervention: Usual Type 2 Diabetes Care<br>The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Diabetes of Self-Care Activities Scale (11- item) | Change in diabetes self-management behaviors (0-7, higher scores indicate improvement) | (T0) baseline through (T3) 90 days post-intervention | 
| Stanford Diabetes Self-Efficacy Scale (8- item) | Change in general self-efficacy 1-10, higher scores indicate improvement) | (T0) baseline through (T3) 90 days post-intervention | 
| Wrist-worn actigraphy (ActiGraph) to be worn while awake | Change in physical activity (Frequent physical activity indicates improvement) | (T0) baseline through (T3) 90 days post-intervention | 
| Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro | Time in range and glucose variability (More time in range and less glucose variability indicates improvement) | (T0) baseline through (T3) 90 days post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6 | Change in diabetes distress ( 0-6, lower scores indicates improvement) | (T0) baseline through (T3) 90 days post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immigrant Health, Diabetes Mellitus, Type 2, Metabolic Diseases, Self-Management Behaviors, Haitian Americans