Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00505960
First received: July 20, 2007
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged ethnic minority immigrant populations (Korean Americans) with type 2 DM.


Condition Intervention Phase
Diabetes
Behavioral: Diabetes Care for Korean Americans
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Diabetes Care for Korean Americans

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 30 Weeks ] [ Designated as safety issue: No ]
    The primary outcome varialbe is hemoglobin A1c level of the study participants to assess the status of blood gluocse management and control during previous 2-3 months.


Secondary Outcome Measures:
  • BP control [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Diabetes Care for Korean Americans
Intervention group participants receive a 6-week in-class education offered by trained nurses, followed by home glucose monitoring with monthly nurse telephone counseling.

Detailed Description:

Korean American immigrants (KAI), one of the most underserved and understudied minority populations in the U.S., suffer from diabetes, which goes under-diagnosed, inadequately treated and has a potential to result in costly and tragic consequences. Language barriers, the lack of self-confidence, and diminished social support that accompany the acculturation process prevent KAI from improving their health-seeking behaviors. Our previous research has indicated that overwhelming numbers of KAI suffer not only from uncontrolled hyperglycemia but also from a loss of self-confidence and social isolation because of language and cultural barriers. They are in urgent need of an intervention to assist them in their efforts to achieve better glycemic control and restore their self-confidence in diabetes and health management so that they are able to adjust successfully in this new environment. Therefore, The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged KAIs with type 2 DM.

This pilot project will test the hypothesis: Compared to KAI in the control group, KAI with type 2 DM who receive a comprehensive DM management intervention through structured psycho-behavioral education, home glucose monitoring with a telephone transmission system, and interaction with a bilingual nurse case manager will show: (1) a greater level of glucose control; and (2) a greater level of self-help skills including knowledge related to glucose control, problem-solving skills, heightened confidence and mood/affect, adherence to treatment recommendations, and quality of life. An additional outcome will be to measure and obtain an ideal BP as the proposed intervention focuses on management of multiple risk factors with which many KA DM patients often struggle.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identified as a first generation Korean American
  • Age 30 years or older
  • Resides in Washington-Baltimore area
  • Expresses willingness to participate in all aspects of the study over its full course
  • Written consent to participate in the screening/eligibility visit
  • Self-identified with DM and HbA1c >= 8% within 6 months of screening
  • Written consent to participate in the clinical trial: agreeing to participate in study data collection procedures, receiving DM self -help education, using HGMT, and permitting contact with their own medical care provider.

Exclusion Criteria:

  • Unable to give informed consent
  • Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
  • Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505960

Locations
United States, Maryland
Korean Resource Center
Ellicott City, Maryland, United States, 20143
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Miyong T Kim, PhD Johns Hopkins University School of Nursing
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miyong T. Kim, The Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00505960     History of Changes
Other Study ID Numbers: R34DK071957
Study First Received: July 20, 2007
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 23, 2014