Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans
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|ClinicalTrials.gov Identifier: NCT00505960|
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : December 21, 2010
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Diabetes Care for Korean Americans||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Diabetes Care for Korean Americans|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
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.
- HbA1c [ Time Frame: 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.
- BP control [ Time Frame: 30 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505960
|United States, Maryland|
|Korean Resource Center|
|Ellicott City, Maryland, United States, 20143|
|Principal Investigator:||Miyong T Kim, PhD||Johns Hopkins University School of Nursing|