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Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00505960
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
12
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Diabetes Care for Korean Americans
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Diabetes Care for Korean Americans
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. HbA1c [30 Weeks]

    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

  1. BP control [30 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00505960
Other Study ID Numbers:
  • R34DK071957
First Posted:
Jul 25, 2007
Last Update Posted:
Dec 21, 2010
Last Verified:
Dec 1, 2010
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of Dec 21, 2010