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Community-Based Diabetes Care for Korean American Immigrants

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Miyong Kim, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01264796
First received: December 20, 2010
Last updated: March 6, 2017
Last verified: March 2012
  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
Type 2 Diabetes
Behavioral: culturally tailored diabetes education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Community-Based Diabetes Care for Korean American Immigrants

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12month ]
    HbA1c level change from baseline comparing with control group

  • Blood pressure [ Time Frame: 12 month ]
    BP change from baseline comparing with control group

  • Lipid profile [ Time Frame: 12 months ]
    LDL level change from baseline comparing with control group

  • quality of life [ Time Frame: 12month ]
    quality of life score change from baseline comparing with control group


Enrollment: 250
Study Start Date: November 2009
Study Completion Date: August 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: behavioral intervention, counseling
2hr group education for 6 weeks
Behavioral: culturally tailored diabetes education
lifestyle modification group education
Other Name: lifestyle modification
No Intervention: delyed intervention
control group

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
University of Texas at Austin
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miyong Kim, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01264796     History of Changes
Other Study ID Numbers: 1R18DK083936-01 ( US NIH Grant/Contract Award Number )
Study First Received: December 20, 2010
Last Updated: March 6, 2017

Keywords provided by University of Texas at Austin:
Korean American, type 2 diabetes, culturally 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 March 28, 2017