AI-based Social Software to Manage wARfarin Therapy (AI-SMART)
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|ClinicalTrials.gov Identifier: NCT03870581|
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anticoagulant-induced Bleeding Warfarin Sodium Causing Adverse Effects in Therapeutic Use||Behavioral: AI-based social software management model Behavioral: Human-based social software management model||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Participants did not know whether they were assigned to AI-SMART group or Human-SMART group.|
|Official Title:||Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||May 1, 2021|
Experimental: AI-SMART group
Participants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software.
Behavioral: AI-based social software management model
a AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
Other Name: Warfarin Helper-AI
Active Comparator: Human-SMART group
Participants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software.
Behavioral: Human-based social software management model
a Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
Other Name: Warfarin Helper
- Time in therapeutic range [ Time Frame: 24 months ]Calculated Time of international normalized ratio in therapeutic range
- INR variability [ Time Frame: 24 months ]coefficient of variation of international normalized ratio (INR)
- Bleeding events [ Time Frame: 24 months ]Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding
- Thrombotic events [ Time Frame: 24 months ]Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al
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): NCT03870581
|Wuhan, Hubei, China, 430000|
|Wuhan Asia Heart Hospital|
|Wuhan, Hubei, China, 430022|