Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged ethnic minority immigrant populations (Korean Americans) with type 2 DM.

Detailed Description
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Korean American immigrants (KAI), one of the most underserved and understudied minority populations in the U.S., suffer from diabetes, which goes under-diagnosed, inadequately treated and has a potential to result in costly and tragic consequences. Language barriers, the lack of self-confidence, and diminished social support that accompany the acculturation process prevent KAI from improving their health-seeking behaviors. Our previous research has indicated that overwhelming numbers of KAI suffer not only from uncontrolled hyperglycemia but also from a loss of self-confidence and social isolation because of language and cultural barriers. They are in urgent need of an intervention to assist them in their efforts to achieve better glycemic control and restore their self-confidence in diabetes and health management so that they are able to adjust successfully in this new environment. Therefore, The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged KAIs with type 2 DM. This pilot project will test the hypothesis: Compared to KAI in the control group, KAI with type 2 DM who receive a comprehensive DM management intervention through structured psycho-behavioral education, home glucose monitoring with a telephone transmission system, and interaction with a bilingual nurse case manager will show: (1) a greater level of glucose control; and (2) a greater level of self-help skills including knowledge related to glucose control, problem-solving skills, heightened confidence and mood/affect, adherence to treatment recommendations, and quality of life. An additional outcome will be to measure and obtain an ideal BP as the proposed intervention focuses on management of multiple risk factors with which many KA DM patients often struggle.

Official Title
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Diabetes Care for Korean Americans

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Diabetes Care for Korean Americans


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identified as a first generation Korean American Age 30 years or older Resides in Washington-Baltimore area Expresses willingness to participate in all aspects of the study over its full course Written consent to participate in the screening/eligibility visit Self-identified with DM and HbA1c >= 8% within 6 months of screening Written consent to participate in the clinical trial: agreeing to participate in study data collection procedures, receiving DM self -help education, using HGMT, and permitting contact with their own medical care provider. 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.

Ages Eligible for Study
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Minimum Age: 30 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Diabetes Care for Korean Americans<br>* Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | The primary outcome varialbe is hemoglobin A1c level of the study participants to assess the status of blood gluocse management and control during previous 2-3 months. | 30 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP control |  | 30 weeks |