Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Time in therapeutic range
研究概览
简要总结
The investigators have demonstrated that social software could improve warfarin therapy quality by Human management. however,the efficiency of management will decline if patients' number expands huge. So it is needed that a human-like and automatic management tool could replace the human work. The aim of this study is to evaluate whether an AI-based social software management model could replace human to guide warfarin therapy.
详细描述
- The investigators have developed an AI-based miniprogram, and embedded in the Wechat social application.
- The investigators invited patients receiving warfarin therapy to participant this randomized controlled trial .
- Participants were randomized to the experimental group and control group in a ratio of 1:1.
- Participants' warfarin therapy were managed by an AI-based social miniprogram and a Human-based social miniprogram respectively.
- International normalized ratio(INR) was monitored once a month at least, and the time in therapeutic range was calculated to evaluate the warfarin anticoagulation quality.
- Participants were followed-up for 24 months, and clinical events, including major bleedings and thrombotic events were recorded during follow-up.
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
- Single (Participant)
盲法说明
Participants did not know whether they were assigned to AI-SMART group or Human-SMART group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Atrial fibrillation
- •Patients with Mechanical valve replacement
- •Patients receiving warfarin therapy
排除标准
- •Plan to stop warfarin therapy within 1 years
- •Bleeding within 3 months
- •Refuse to participate in this study
- •Other conditions that the physician considers inappropriate for participation
研究组 & 干预措施
AI-SMART group
Participants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software.
干预措施: AI-based social software management model (Behavioral)
Human-SMART group
Participants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software.
干预措施: Human-based social software management model (Behavioral)
结局指标
主要结局
Time in therapeutic range
时间窗: 24 months
Calculated Time of international normalized ratio in therapeutic range
INR variability
时间窗: 24 months
coefficient of variation of international normalized ratio (INR)
次要结局
- Bleeding events(24 months)
- Thrombotic events(24 months)
研究者
Litao Zhang, MD
Head of anticoagulation clinic
Wuhan Asia Heart Hospital