AI-based Social Software to Manage wARfarin Therapy

Anticoagulant-induced Bleeding Clinical Trial

— AI-SMART  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03870581
• Other study ID #: 2019-P-012
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2019
• Source: Wuhan Asia Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 1, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	WAHH	Wuhan	Hubei
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in therapeutic range	Calculated Time of international normalized ratio in therapeutic range	24 months
Primary	INR variability	coefficient of variation of international normalized ratio (INR)	24 months
Secondary	Bleeding events	Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding	24 months
Secondary	Thrombotic events	Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al	24 months