Clinical trial NCT01264796: Community-Based Diabetes Care for Korean American Immigrants
Official title: Community-Based Diabetes Care for Korean American Immigrants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Korean American, type 2 diabetes, culturally tailored
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-12-22
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Inclusion Criteria

1. Self-identified as a first generation Korean American
2. Type 2 diabetes
3. Age 30-75 years
4. Resides in Washington-Baltimore area
5. Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening
6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion criteria

1. Unable to give informed consent
2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
4. Past experience in diabetes group education

Eligibility criteria: Inclusion Criteria:

1. Self-identified as a first generation Korean American
2. Type 2 diabetes
3. Age 30-75 years
4. Resides in Washington-Baltimore area
5. Self-identified with DM and HbA1c \>= 7.0 % within 6 months of screening
6. Expresses willingness to participate in all aspects of the study over its full course

Exclusion Criteria:

1. Unable to give informed consent
2. Physical or mental health conditions that could limit active participation in the study (e.g., blindness in both eyes, severe immobility, psychiatric diseases)
3. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia
4. Past experience in diabetes group education

Primary outcomes:
measure: HbA1c
timeFrame: 12month
measure: Blood pressure
timeFrame: 12 month
measure: Lipid profile
timeFrame: 12 months
measure: quality of life
timeFrame: 12month
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References:
citation: 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.
citation: Kim 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.
citation: Kim 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.
citation: Kim 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.