AI-based Social Software to Manage wARfarin Therapy

Not Applicable

• Conditions: Anticoagulant-induced Bleeding; Warfarin Sodium Causing Adverse Effects in Therapeutic Use
• Interventions: Behavioral: Human-based social software management model; Behavioral: AI-based social software management model

• Registration Number: NCT03870581
• Lead Sponsor: Wuhan Asia Heart Hospital

Brief Summary

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

1. The investigators have developed an AI-based miniprogram, and embedded in the Wechat social application.

2. The investigators invited patients receiving warfarin therapy to participant this randomized controlled trial .

3. Participants were randomized to the experimental group and control group in a ratio of 1:1.

4. Participants' warfarin therapy were managed by an AI-based social miniprogram and a Human-based social miniprogram respectively.

5. 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.

6. Participants were followed-up for 24 months, and clinical events, including major bleedings and thrombotic events were recorded during follow-up.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Study First Posted: 2019-03-12
• Last Update Posted: 2019-03-12
• Study Start: 2019-05-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human-SMART group	Human-based social software management model	Participants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software.
AI-SMART group	AI-based social software management model	Participants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software.

Primary Outcome Measures

Name	Time	Method
Time in therapeutic range	24 months	Calculated Time of international normalized ratio in therapeutic range
INR variability	24 months	coefficient of variation of international normalized ratio (INR)

Secondary Outcome Measures

Name	Time	Method
Bleeding events	24 months	Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding
Thrombotic events	24 months	Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al

Trial Locations

Locations (2)

WAHH; 🇨🇳 Wuhan, Hubei, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China