AI-based Social Software to Manage wARfarin Therapy (AI-SMART)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Asia Heart Hospital
    • Wuhan, Hubei, China, 430000
      • WAHH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Warfarin Helper

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wuhan Asia Heart Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2019
• Primary Completion (ANTICIPATED): April 30, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (ACTUAL): March 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: warfarin; Artificial intelligence; INR; anticoagulation therapy; social software
• Additional Relevant MeSH Terms: Anticoagulants; Warfarin
• Other Study ID Numbers: 2019-P-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No