Community-Based Diabetes Care for Korean American Immigrants
1 other identifier
interventional
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Nov 2009
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 20, 2010
CompletedFirst Posted
Study publicly available on registry
December 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMarch 8, 2017
March 1, 2012
4.7 years
December 20, 2010
March 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
HbA1c
HbA1c level change from baseline comparing with control group
12month
Blood pressure
BP change from baseline comparing with control group
12 month
Lipid profile
LDL level change from baseline comparing with control group
12 months
quality of life
quality of life score change from baseline comparing with control group
12month
Study Arms (2)
behavioral intervention, counseling
EXPERIMENTAL2hr group education for 6 weeks
delyed intervention
NO INTERVENTIONcontrol group
Interventions
lifestyle modification group education
Eligibility Criteria
You may qualify if:
- Self-identified as a first generation Korean American
- Type 2 diabetes
- Age 30-75 years
- Resides in Washington-Baltimore area
- Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening
- Expresses willingness to participate in all aspects of the study over its full course
You may not qualify if:
- 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
- Past experience in diabetes group education
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Related Publications (4)
Kim MT, Kim KB, Ko J, Murry N, Xie B, Radhakrishnan K, Han HR. Health Literacy and Outcomes of a Community-Based Self-Help Intervention: A Case of Korean Americans With Type 2 Diabetes. Nurs Res. 2020 May/Jun;69(3):210-218. doi: 10.1097/NNR.0000000000000409.
PMID: 31972848DERIVEDKim MT, Kim KB, Ko J, Murry N, Levine D, Lee JY. The Differential Role of Vitamin D in Type 2 Diabetes Management and Control in Minority Populations. J Immigr Minor Health. 2019 Dec;21(6):1266-1274. doi: 10.1007/s10903-019-00857-x.
PMID: 30747313DERIVEDKim MT, Kim KB, Ko J, Jang Y, Levine D, Lee HB. Role of depression in diabetes management in an ethnic minority population: a case of Korean Americans with type 2 diabetes. BMJ Open Diabetes Res Care. 2017 Mar 24;5(1):e000337. doi: 10.1136/bmjdrc-2016-000337. eCollection 2017.
PMID: 28405343DERIVEDKim MT, Kim KB, Huh B, Nguyen T, Han HR, Bone LR, Levine D. The Effect of a Community-Based Self-Help Intervention: Korean Americans With Type 2 Diabetes. Am J Prev Med. 2015 Nov;49(5):726-737. doi: 10.1016/j.amepre.2015.04.033. Epub 2015 Jul 14.
PMID: 26184986DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 20, 2010
First Posted
December 22, 2010
Study Start
November 1, 2009
Primary Completion
July 1, 2014
Study Completion
August 1, 2015
Last Updated
March 8, 2017
Record last verified: 2012-03