Community-Based Diabetes Care for Korean American Immigrants

Study Overview
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Brief Summary
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The primary aims are to test the effectiveness of the self-help DM intervention (SHIP-DM), a comprehensive, culturally tailored DM management intervention, in improving glucose outcomes; To determine the effectiveness of the SHIP-DM in KAI with type 2 DM in improving self-care skills and psycho-behavioral outcomes related to DM control, to develop tangible infrastructures for the dissemination of valid and effective education materials to a wider population of KAI with type 2 DM in the US (e.g., audio-visual education materials, web-based intervention materials, mobile telephone-based intervention materials) and to explore the feasibility and acceptability of each dissemination module, utilizing the delayed intervention group participants. The secondary aims are to obtain preliminary cost-effectiveness data related to the proposed intervention, including cost estimates for this type of DM intervention, and to establish a systematic, long-term dissemination plan, including documenting effective methodologies, to facilitate faster translation of research findings and products to direct consumers in non-research settings.

Detailed Description
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Inclusion Criteria Self-identified as a first generation Korean American Type 2 diabetes Age 30-75 years Resides in Washington-Baltimore area Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening Expresses willingness to participate in all aspects of the study over its full course Exclusion criteria Unable to give informed consent Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases) Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia Past experience in diabetes group education

Official Title
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Community-Based Diabetes Care for Korean American Immigrants

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: culturally tailored diabetes education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identified as a first generation Korean American Type 2 diabetes Age 30-75 years Resides in Washington-Baltimore area Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening Expresses willingness to participate in all aspects of the study over its full course Exclusion Criteria: Unable to give informed consent Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases) Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia Past experience in diabetes group education

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: behavioral intervention, counseling<br>2hr group education for 6 weeks | Behavioral: culturally tailored diabetes education<br>* lifestyle modification group education<br>* Other names: lifestyle modification;|
| No Intervention: delyed intervention<br>control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c level change from baseline comparing with control group | 12month | 
| Blood pressure | BP change from baseline comparing with control group | 12 month | 
| Lipid profile | LDL level change from baseline comparing with control group | 12 months | 
| quality of life | quality of life score change from baseline comparing with control group | 12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korean American, type 2 diabetes, culturally tailored