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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social-software management group | Experimental | 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. |
|
| Routine management group | No Intervention | This is the control group, Warfarin therapy was managed via traditional style without social software intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social-software management | Behavioral | Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Event | Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage,gastrointestinal bleeding etc. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time in therapeutic range | Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio | Up to 18 months |
| Individual variation of International Normalized Ratio (INR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenlu Zhang, MD,PhD | Wuhan Asia Heart Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WAHH | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36714197 | Derived | Zhang L, Li S, Li Z, Yu D, Wu H, Hua B, Xie L, Yuan X, Li Y, Zhang Z, Long Y. Social App to Improve Warfarin Therapy in Post-MHVR Chinese Patients: A Randomized Controlled Trial. Cardiovasc Ther. 2023 Jan 14;2023:2342111. doi: 10.1155/2023/2342111. eCollection 2023. |
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We are going to make individual participant data (IPD) available to other researchers after our paper published
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Standard deviation (SD) of individual INR results
| Up to 18 months |
| Times of extremely high International Normalized Ratio (INR) values | Times of INR results above 4.0; Times of INR results above 12.0 | Up to 18 months |