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Trial record 43 of 231 for:    warfarin AND International

Social-software iMproving wARfarin Therapy (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03264937
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Litao Zhang, MD, Wuhan Asia Heart Hospital

Brief Summary:
Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin therapy in traditional health care settings. Improving warfarin therapy has been crucial for Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat, as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese patients' warfarin therapy. We aim to assess whether social software could improve warfarin therapy in Chinese patients by conducting a single-centre, open-label, prospective, randomized clinical trial.

Condition or disease Intervention/treatment Phase
Anticoagulants Causing Adverse Effects in Therapeutic Use Patient Compliance Behavioral: Social-software management Not Applicable

Detailed Description:

Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the most popular social software in China. People can chat with others no matter how far away from each other.

Anticoagulation Quality is very important for patients receiving warfarin anticoagulation therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR is very low (38.8%) in China patients. So we are planning to introduce the social software to set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to investigate whether social software could be used to improve warfarin anticoagulation quality of Chinese patients.

We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical valves in a randomized controlled trial. Warfarin-treated patients were assigned to social software management group ( in which warfarin therapy was guided via the social platform by experienced clinicians) or to the traditional management control group (in which warfarin therapy was managed with traditional model). The primary outcomes the first time to bleeding or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range (TTR) of international normalized ratio (INR), reduction in INR variation and number of extremely high INR results during 18 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 735 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Social-software management group
We set up a mini-program based on wechat application. We instruct warfarin therapy via social-software including dose adjustment, answer questions, remind monitoring INR et.al.
Behavioral: Social-software management
Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.

No Intervention: Routine management group
This is the control group, Warfarin therapy was managed via traditional style without social software intervention.



Primary Outcome Measures :
  1. Time to First Event [ Time Frame: Up to 18 months ]
    Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage,gastrointestinal bleeding etc.


Secondary Outcome Measures :
  1. Time in therapeutic range [ Time Frame: Up to 18 months ]
    Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio

  2. Individual variation of International Normalized Ratio (INR) [ Time Frame: Up to 18 months ]
    Standard deviation (SD) of individual INR results

  3. Times of extremely high International Normalized Ratio (INR) values [ Time Frame: Up to 18 months ]
    Times of INR results above 4.0; Times of INR results above 12.0



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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:

  • Received mechanical valve replacement;
  • Receiving warfarin anticoagulation therapy;
  • Have smartphone and Know how to use wechat application and our mini-program;
  • be expected to survive for the duration of the study;
  • not be suffering from intracranial bleeding (intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke) or any other contraindication described in the warfarin package insert;
  • be willing to be randomized;
  • sign the informed consent form;
  • not be enrolled in another randomized clinical trial that involves a drug or device intervention.

Exclusion Criteria:

  • subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
  • subject enrolled in another randomized clinical trial that involves a drug or device intervention
  • subject is not able to follow the protocol and all related instructions and does not have a caregiver with these skills
  • Patients were considered being not suitable for this study

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): NCT03264937


Locations
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China, Hubei
WAHH
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Wuhan Asia Heart Hospital
Investigators
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Study Director: Zhenlu Zhang, MD,PhD Wuhan Asia Heart Hospital

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Responsible Party: Litao Zhang, MD, Manager of anticoagulation clinic, Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT03264937     History of Changes
Other Study ID Numbers: 2017-P-033
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are going to make individual participant data (IPD) available to other researchers after our paper published
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:
TTR
INR
Warfarin
social software
Additional relevant MeSH terms:
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Warfarin
Anticoagulants