Social-software iMproving wARfarin Therapy

Patient Compliance Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264937
• Other study ID #: 2017-P-033
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 8, 2019

Study information

• Verified date: June 2019
• Source: Wuhan Asia Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 735
• Est. completion date: March 8, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants Causing Adverse Effects in Therapeutic Use
• Patient Compliance

Intervention

Behavioral:
• Social-software management
Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.

Locations

Country	Name	City	State
China	WAHH	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time in therapeutic range	Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio	Up to 18 months
Secondary	Individual variation of International Normalized Ratio (INR)	Standard deviation (SD) of individual INR results	Up to 18 months
Secondary	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