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Completed

NCT Number: NCT03264937

Social-software iMproving wARfarin Therapy

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.

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Key information

Conditions

Anticoagulants Causing Adverse Effects in Therapeutic Use Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WAHH

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social-software management

Behavioral

Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wuhan Asia Heart Hospital

Other

Registry information

Official study title

Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement

Acronym: SMART

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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