AI-based Social Software to Manage wARfarin Therapy

NCT ID: NCT03870581

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AI-SMART group

Participants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software.

Group Type: EXPERIMENTAL

AI-based social software management model

Intervention Type: BEHAVIORAL

a AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.

Human-SMART group

Participants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software.

Group Type: ACTIVE_COMPARATOR

Human-based social software management model

Intervention Type: BEHAVIORAL

a Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Warfarin Helper-AI; Warfarin Helper

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Asia Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Litao Zhang, MD

Head of anticoagulation clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

WAHH

Wuhan, Hubei, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

2019-P-012

Identifier Type: -

Identifier Source: org_study_id