Social-software iMproving wARfarin Therapy (SMART)
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|ClinicalTrials.gov Identifier: NCT03264937|
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anticoagulants Causing Adverse Effects in Therapeutic Use Patient Compliance||Behavioral: Social-software management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||735 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||March 8, 2019|
Experimental: 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.
Behavioral: Social-software management
Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
No Intervention: Routine management group
This is the control group, Warfarin therapy was managed via traditional style without social software intervention.
- Time to First Event [ Time Frame: Up to 18 months ]Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.
- Time in therapeutic range [ Time Frame: Up to 18 months ]Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
- Individual variation of International Normalized Ratio (INR) [ Time Frame: Up to 18 months ]Standard deviation (SD) of individual INR results
- Times of extremely high International Normalized Ratio (INR) values [ Time Frame: Up to 18 months ]Times of INR results above 4.0; Times of INR results above 12.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264937
|Wuhan, Hubei, China, 430000|
|Study Director:||Zhenlu Zhang, MD,PhD||Wuhan Asia Heart Hospital|