Social-software iMproving wARfarin Therapy (SMART)
Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hubei
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Wuhan、Hubei、中国、430000
- WAHH
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
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无干预：Routine management group
This is the control group, Warfarin therapy was managed via traditional style without social software intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to First Event
大体时间：Up to 18 months
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Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.
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Up to 18 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time in therapeutic range
大体时间：Up to 18 months
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Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
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Up to 18 months
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Individual variation of International Normalized Ratio (INR)
大体时间：Up to 18 months
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Standard deviation (SD) of individual INR results
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Up to 18 months
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Times of extremely high International Normalized Ratio (INR) values
大体时间：Up to 18 months
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Times of INR results above 4.0; Times of INR results above 12.0
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Up to 18 months
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合作者和调查者
调查人员
- 研究主任：Zhenlu ZHANG, MD,PhD、Wuhan Asia Heart Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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