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AI-SMART: AI-based Social Software to Manage wARfarin Therapy

Sponsor
Wuhan Asia Heart Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03870581
Collaborator
(none)
500
Enrollment
2
Locations
2
Arms
24
Anticipated Duration (Months)
250
Patients Per Site
10.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: AI-based social software management model
  • Behavioral: Human-based social software management model
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants did not know whether they were assigned to AI-SMART group or Human-SMART group.
Primary Purpose:
Treatment
Official Title:
Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial
Anticipated Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time in therapeutic range [24 months]

      Calculated Time of international normalized ratio in therapeutic range

    2. INR variability [24 months]

      coefficient of variation of international normalized ratio (INR)

    Secondary Outcome Measures

    1. Bleeding events [24 months]

      Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding

    2. Thrombotic events [24 months]

      Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WAHH Wuhan Hubei China 430000
    2 Wuhan Asia Heart Hospital Wuhan Hubei China 430022

    Sponsors and Collaborators

    • Wuhan Asia Heart Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Litao Zhang, MD, Head of anticoagulation clinic, Wuhan Asia Heart Hospital
    ClinicalTrials.gov Identifier:
    NCT03870581
    Other Study ID Numbers:
    • 2019-P-012
    First Posted:
    Mar 12, 2019
    Last Update Posted:
    Mar 12, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Litao Zhang, MD, Head of anticoagulation clinic, Wuhan Asia Heart Hospital
    Artificial intelligence
    social software
    warfarin
    anticoagulation therapy
    INR
    Additional relevant MeSH terms:
    Warfarin

    Study Results

    No Results Posted as of Mar 12, 2019