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

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ClinicalTrials.gov Identifier: NCT03870581
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Litao Zhang, MD, 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.

Condition or disease Intervention/treatment Phase
Anticoagulant-induced Bleeding Warfarin Sodium Causing Adverse Effects in Therapeutic Use Behavioral: AI-based social software management model Behavioral: Human-based social software management model Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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 Name: 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 Name: Warfarin Helper




Primary Outcome Measures :
  1. Time in therapeutic range [ Time Frame: 24 months ]
    Calculated Time of international normalized ratio in therapeutic range

  2. INR variability [ Time Frame: 24 months ]
    coefficient of variation of international normalized ratio (INR)


Secondary Outcome Measures :
  1. Bleeding events [ Time Frame: 24 months ]
    Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding

  2. Thrombotic events [ Time Frame: 24 months ]
    Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870581


Locations
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China, Hubei
WAHH
Wuhan, Hubei, China, 430000
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Wuhan Asia Heart Hospital

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Responsible Party: Litao Zhang, MD, Head of anticoagulation clinic, Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT03870581     History of Changes
Other Study ID Numbers: 2019-P-012
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Litao Zhang, MD, Wuhan Asia Heart Hospital:
Artificial intelligence
social software
warfarin
anticoagulation therapy
INR
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Warfarin
Anticoagulants