Systematic Medical Assessment, Referral and Treatment for Diabetes Care in China Using Lay Family Health Promoters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,073
- 试验地点
- 2
- 主要终点
- The proportion of patients achieving at least two "ABC" goals
研究概览
简要总结
It's a community-based parallel-arm cluster Randomized Controlled Trial (RCT). An interactive mobile health management system will be developed to support lay family health promoters and healthcare staff to improve clinical outcomes for family members with Type 2 Diabetes Mellitus (T2DM). 2,000 participants from 80 sites will be chosen from urban (40 communities) and rural (40 villages) settings in Shijiazhuang City, Hebei Province.
详细描述
Study design and Settings:
Cluster randomised controlled trial involving 80 sites (40 communities in urban Shijiazhuang and 40 villages in rural Shijiazhuang) and 2,000 people with T2DM.
Hypothesis:
An interactive mobile health management system can support lay family health promoters (FHP) and healthcare staff to improve clinical outcomes for family members with T2DM
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established T2DM
- •HbA1C >= 7%
- •Nominated family member with mobile internet access who agrees to be a family health promoter (FHP)
- •Able to provide informed consent
排除标准
- •Psychologically or physically unable to participate the trials.
结局指标
主要结局
The proportion of patients achieving at least two "ABC" goals
时间窗: 24 months
The proportion of patients achieving at least two "ABC" goals defined as any two of the following: HbA1c \<7.0%, blood pressure (BP) \<140/80mmHg and LDL cholesterol \<100mg/dl or 2.6mmol/L) at 24 months
次要结局
- The proportion of patients achieving the "B" goal(24 months)
- The proportion of patients achieving the "C" goal(24 months)
- The proportion of patients achieving FPG<7.0 mmol/L(24 months)
- Mean changes in systolic and diastolic blood pressure levels(24 months)
- The proportion of patients achieving the "A" goal(24 months)
- Mean change in HbA1c level(24 months)
- Mean change in LDL cholesterol level(24 months)
- Mean change in FPG level(24 months)
- Mean change in the Summary of Diabetes Self-Care Activities (SDSCA) from baseline to 24 month(24 months)
研究者
Puhong Zhang
Associate Director
The George Institute for Global Health, China