Partners in Care With Semi-Structured Support Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- Change from Baseline hemoglobin a1c at 3 months and at 6 months
研究概览
简要总结
The investigators are conducting a feasibility study using a randomized controlled trial (RCT) design in which participants will receive the Partners in Care (PIC) diabetes self-management intervention and then be randomized to either semi-structured social support or a standard follow-up control group. Participants in the support groups will receive a culturally-tailored, semi-structured social support program delivered in a community setting by trained community peer educators and other health professionals (e.g., pharmacist). The investigators believe that the addition of a semi-structured social support component as a supplement to an evidence-based diabetes self-management intervention will improve diabetes self-care maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background
- •Adults age >18 years of age
- •English-speaking
- •Physician-diagnosed type 2 diabetes
- •Baseline hemoglobin A1c >8%
排除标准
- •Survival less than 6 months
- •Planning to move out of the community during the intervention study period
- •Pregnancy
- •Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness)
结局指标
主要结局
Change from Baseline hemoglobin a1c at 3 months and at 6 months
时间窗: baseline, 3 months, 6 months
Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months
时间窗: baseline, 3 months, 6 months
The PAID is a 20-item instrument that assesses the physical and social functioning of patients as well as their perceived level of mental and emotional well-being specific to living with diabetes.
次要结局
- Change from Baseline weight in kg at 3 months and 6 months(baseline, 3 months, 6 months)
- Change from Baseline blood pressure at 3 months and 6 months(baseline, 3 months, 6 months)
- Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months(baseline, 3 months, 6 months)
研究者
Claire Townsend
Clinical Research Specialist
University of Hawaii