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
1 other identifier
interventional
500
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMarch 12, 2019
March 1, 2019
2 years
March 8, 2019
March 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Bleeding events
24 months
Thrombotic events
24 months
Study Arms (2)
AI-SMART group
EXPERIMENTALParticipants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software.
Human-SMART group
ACTIVE COMPARATORParticipants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software.
Interventions
a AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
a Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
Eligibility Criteria
You may qualify if:
- Patients with Atrial fibrillation
- Patients with Mechanical valve replacement
- Patients receiving warfarin therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
WAHH
Wuhan, Hubei, 430000, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants did not know whether they were assigned to AI-SMART group or Human-SMART group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of anticoagulation clinic
Study Record Dates
First Submitted
March 8, 2019
First Posted
March 12, 2019
Study Start
May 1, 2019
Primary Completion
April 30, 2021
Study Completion
May 1, 2021
Last Updated
March 12, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR