Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 735
- 试验地点
- 1
- 主要终点
- Time to First Event
研究概览
简要总结
Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin therapy in traditional health care settings. Improving warfarin therapy has been crucial for Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat, as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese patients' warfarin therapy. We aim to assess whether social software could improve warfarin therapy in Chinese patients by conducting a single-centre, open-label, prospective, randomized clinical trial.
详细描述
Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the most popular social software in China. People can chat with others no matter how far away from each other.
Anticoagulation Quality is very important for patients receiving warfarin anticoagulation therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR is very low (38.8%) in China patients. So we are planning to introduce the social software to set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to investigate whether social software could be used to improve warfarin anticoagulation quality of Chinese patients.
We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical valves in a randomized controlled trial. Warfarin-treated patients were assigned to social software management group ( in which warfarin therapy was guided via the social platform by experienced clinicians) or to the traditional management control group (in which warfarin therapy was managed with traditional model). The primary outcomes the first time to bleeding or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range (TTR) of international normalized ratio (INR), reduction in INR variation and number of extremely high INR results during 18 months.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received mechanical valve replacement;
- •Receiving warfarin anticoagulation therapy;
- •Have smartphone and Know how to use wechat application and our mini-program;
- •be expected to survive for the duration of the study;
- •not be suffering from intracranial bleeding (intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke) or any other contraindication described in the warfarin package insert;
- •be willing to be randomized;
- •sign the informed consent form;
- •not be enrolled in another randomized clinical trial that involves a drug or device intervention.
排除标准
- •subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- •subject enrolled in another randomized clinical trial that involves a drug or device intervention
- •subject is not able to follow the protocol and all related instructions and does not have a caregiver with these skills
- •Patients were considered being not suitable for this study
研究组 & 干预措施
Social-software management group
We set up a mini-program based on wechat application. We instruct warfarin therapy via social-software including dose adjustment, answer questions, remind monitoring INR et.al.
干预措施: Social-software management (Behavioral)
Routine management group
This is the control group, Warfarin therapy was managed via traditional style without social software intervention.
结局指标
主要结局
Time to First Event
时间窗: Up to 18 months
Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.
次要结局
- Time in therapeutic range(Up to 18 months)
- Individual variation of International Normalized Ratio (INR)(Up to 18 months)
- Times of extremely high International Normalized Ratio (INR) values(Up to 18 months)
研究者
Litao Zhang, MD
Manager of anticoagulation clinic
Wuhan Asia Heart Hospital