Community-Based Diabetes Care for Korean American Immigrants

March 6, 2017 updated by: Miyong Kim, University of Texas at Austin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: behavioral intervention, counseling
2hr group education for 6 weeks
Behavioral: culturally tailored diabetes education
lifestyle modification group education
Other Names:
  • lifestyle modification
No Intervention: delyed intervention
control group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18DK083936-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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