Community-Based Diabetes Care for Korean American Immigrants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- quality of life
研究概览
简要总结
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.
详细描述
Inclusion Criteria
- 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
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
- Past experience in diabetes group education
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
quality of life
时间窗: 12month
quality of life score change from baseline comparing with control group
Lipid profile
时间窗: 12 months
LDL level change from baseline comparing with control group
Blood pressure
时间窗: 12 month
BP change from baseline comparing with control group
HbA1c
时间窗: 12month
HbA1c level change from baseline comparing with control group
次要结局
未报告次要终点
研究者
Miyong Kim
Professor
Johns Hopkins University