Community-Based Diabetes Care for Korean American Immigrants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-08-31

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.

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Detailed Description

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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

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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behavioral intervention, counseling

2hr group education for 6 weeks

Group Type EXPERIMENTAL

culturally tailored diabetes education

Intervention Type BEHAVIORAL

lifestyle modification group education

delyed intervention

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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culturally tailored diabetes education

lifestyle modification group education

Intervention Type BEHAVIORAL

Other Intervention Names

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lifestyle modification

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No