Social-software iMproving wARfarin Therapy (SMART)

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Compliance; Anticoagulants Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Behavioral: Social-software management

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.

• Study Type: Interventional
• Enrollment (Actual): 735
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • WAHH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Event	Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in therapeutic range	Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio	Up to 18 months
Individual variation of International Normalized Ratio (INR)	Standard deviation (SD) of individual INR results	Up to 18 months
Times of extremely high International Normalized Ratio (INR) values	Times of INR results above 4.0; Times of INR results above 12.0	Up to 18 months

Collaborators and Investigators

• Sponsor: Wuhan Asia Heart Hospital
• Investigators: Study Director: Zhenlu ZHANG, MD,PhD, Wuhan Asia Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: TTR; Warfarin; INR; social software
• Other Study ID Numbers: 2017-P-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are going to make individual participant data (IPD) available to other researchers after our paper published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No