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Community-Based Diabetes Care for Korean American Immigrants

This study is currently recruiting participants.
Verified December 2010 by Johns Hopkins University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01264796
First received: December 20, 2010
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Behavioral: cullurally tailored diabetes education
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Community-Based Diabetes Care for Korean American Immigrants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12month ] [ Designated as safety issue: No ]
    HbA1c level change from baseline comparing with control group

  • Blood pressure [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    BP change from baseline comparing with control group

  • Lipid profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    LDL level change from baseline comparing with control group

  • quality of life [ Time Frame: 12month ] [ Designated as safety issue: No ]
    quality of life score change from baseline comparing with control group


Estimated Enrollment: 240
Study Start Date: November 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: behavioral intervention, counseling
2hr group education for 6 weeks
 Behavioral: cullurally tailored diabetes education
lifestyle modification group education
Other Name: lifestyle modification

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
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264796

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Miyong T Kim, PhD     410-614-1443     mkim@son.jhmi.edu    
Sponsors and Collaborators
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: MIyong Kim, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01264796     History of Changes
Other Study ID Numbers: 1 R18 DK083936-01, 1R18DK083936-01
Study First Received: December 20, 2010
Last Updated: December 21, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Johns Hopkins University:
Korean American, type 2 diabetes, cuturally tailored

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013