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Trial record 12 of 142 for:    warfarin AND therapeutic range

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 12, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Time in therapeutic range [ Time Frame: 24 months ]
    Calculated Time of international normalized ratio in therapeutic range
  • INR variability [ Time Frame: 24 months ]
    coefficient of variation of international normalized ratio (INR)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Bleeding events [ Time Frame: 24 months ]
    Including Cerebral hemorrhage, gastrointestinal bleeding and other major bleeding
  • Thrombotic events [ Time Frame: 24 months ]
    Including stroke, deep vein thrombosis,Pulmonary embolism,Peripheral arterial embolism, et.al
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AI-based Social Software to Manage wARfarin Therapy
Official Title  ICMJE Artificial Intelligence-based Social Software Management Model to Improve Warfarin Anticoagulation Therapy: a Prospective, Single-blind, Randomized Control Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Anticoagulant-induced Bleeding
  • Warfarin Sodium Causing Adverse Effects in Therapeutic Use
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: AI-SMART group
    Participants' warfarin therapy were guided by an AI-based miniprogram embedded in the Wechat social software.
    Intervention: Behavioral: AI-based social software management model
  • Active Comparator: Human-SMART group
    Participants' warfarin therapy were guided by an human-based miniprogram embedded in the Wechat social software.
    Intervention: Behavioral: Human-based social software management model
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870581
Other Study ID Numbers  ICMJE 2019-P-012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Litao Zhang, MD, Wuhan Asia Heart Hospital
Study Sponsor  ICMJE Wuhan Asia Heart Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wuhan Asia Heart Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP