AI-based Social Software to Manage wARfarin Therapy

Study Overview
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Brief Summary
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The investigators have demonstrated that social software could improve warfarin therapy quality by Human management. however,the efficiency of management will decline if patients' number expands huge. So it is needed that a human-like and automatic management tool could replace the human work. The aim of this study is to evaluate whether an AI-based social software management model could replace human to guide warfarin therapy.

Detailed Description
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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.

Official Title
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Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial

Conditions
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Anticoagulant-induced Bleeding, Warfarin Sodium Causing Adverse Effects in Therapeutic Use

Intervention / Treatment
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* Behavioral: AI-based social software management model
* Behavioral: Human-based social software management model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Atrial fibrillation Patients with Mechanical valve replacement Patients receiving warfarin therapy Exclusion Criteria: Plan to stop warfarin therapy within 1 years Bleeding within 3 months Refuse to participate in this study Other conditions that the physician considers inappropriate for participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI-SMART group<br>Participants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software. | Behavioral: AI-based social software management model<br>* a AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.<br>* Other names: Warfarin Helper-AI;|
| Active Comparator: Human-SMART group<br>Participants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software. | Behavioral: Human-based social software management model<br>* a Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.<br>* Other names: Warfarin Helper;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in therapeutic range | Calculated Time of international normalized ratio in therapeutic range | 24 months | 
| INR variability | coefficient of variation of international normalized ratio (INR) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding events | Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding | 24 months | 
| Thrombotic events | Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial intelligence, social software, warfarin, anticoagulation therapy, INR