Social-software iMproving wARfarin Therapy

NCT03264937 | Completed DMC

• 1 other identifier: 2017-P-033
• Study Type: interventional
• Target: 735
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulants Causing Adverse Effects in Therapeutic Use; Patient Compliance

Keywords

TTR; INR; Warfarin; social software

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time in therapeutic range

  Up to 18 months

• Individual variation of International Normalized Ratio (INR)

  Up to 18 months

• Times of extremely high International Normalized Ratio (INR) values

  Up to 18 months

Study Arms (2)

Social-software management group

EXPERIMENTAL

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

Routine management group

NO INTERVENTION

This is the control group, Warfarin therapy was managed via traditional style without social software intervention.

Interventions

Social-software management BEHAVIORAL

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

Social-software management group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuhan Asia Heart Hospital: lead

Study Sites (1)

WAHH

Wuhan, Hubei, 430000, China

Location

Related Publications (1)

• Zhang L, Li S, Li Z, Yu D, Wu H, Hua B, Xie L, Yuan X, Li Y, Zhang Z, Long Y. Social App to Improve Warfarin Therapy in Post-MHVR Chinese Patients: A Randomized Controlled Trial. Cardiovasc Ther. 2023 Jan 14;2023:2342111. doi: 10.1155/2023/2342111. eCollection 2023.

  PMID: 36714197 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Zhenlu Zhang, MD,PhD

  Wuhan Asia Heart Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager of anticoagulation clinic

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 29, 2017
• Study Start: September 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 8, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)