Viewing Study NCT00505960



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Study NCT ID: NCT00505960
Status: COMPLETED
Last Update Posted: 2010-12-21
First Post: 2007-07-20

Brief Title: Culturally Tailored Behavioral Diabetes Care Intervention for Korean Americans
Sponsor: Johns Hopkins University
Organization: Johns Hopkins University

Study Overview

Official Title: Diabetes Care for Korean Americans
Status: COMPLETED
Status Verified Date: 2010-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: Korean American immigrants KAI one of the most underserved and understudied minority populations in the US 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 moodaffect 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None