Community-Based Diabetes Care for Korean American Immigrants

Type 2 Diabetes Clinical Trial

Official title:

Community-Based Diabetes Care for Korean American Immigrants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264796
• Other study ID #: 1R18DK083936-01
• Secondary ID: 1R18DK083936-01
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: March 6, 2017
• Start date: November 2009
• Est. completion date: August 2015

Study information

• Verified date: March 2012
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• culturally tailored diabetes education
lifestyle modification group education

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	HbA1c level change from baseline comparing with control group	12month
Primary	Blood pressure	BP change from baseline comparing with control group	12 month
Primary	Lipid profile	LDL level change from baseline comparing with control group	12 months
Primary	quality of life	quality of life score change from baseline comparing with control group	12month