Community-Based Diabetes Care for Korean American Immigrants

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: culturally tailored diabetes education

• Registration Number: NCT01264796
• Lead Sponsor: University of Texas at Austin

Brief Summary

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

Inclusion Criteria

1. Self-identified as a first generation Korean American

2. Type 2 diabetes

3. Age 30-75 years

4. Resides in Washington-Baltimore area

5. Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening

6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion criteria

1. Unable to give informed consent

2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)

3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia

4. Past experience in diabetes group education

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Status Verified: 2012-03
• Primary Completion: 2014-07
• Study Completion: 2015-08
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Self-identified as a first generation Korean American
2. Type 2 diabetes
3. Age 30-75 years
4. Resides in Washington-Baltimore area
5. Self-identified with DM and HbA1c >= 7.0 % within 6 months of screening
6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion Criteria

1. Unable to give informed consent
2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
4. Past experience in diabetes group education

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
behavioral intervention, counseling	culturally tailored diabetes education	2hr group education for 6 weeks

Primary Outcome Measures

Name	Time	Method
quality of life	12month	quality of life score change from baseline comparing with control group
Lipid profile	12 months	LDL level change from baseline comparing with control group
Blood pressure	12 month	BP change from baseline comparing with control group
HbA1c	12month	HbA1c level change from baseline comparing with control group

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States