INR at Home Measurement by the LabPad® Point-of-care in Patients on Vitamin K Antagonist Drugs (VKA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-03

Study Completion Date

2020-04-03

Brief Summary

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This study evaluates the impact of using LabPad® point-of-care to measure International Normalized Ratio (INR) at home on the patient's follow up on vitamine K antagonist (VKA) treatment during 6 months.

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Detailed Description

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The impact of the LabPad® point-of-care use by the nurse will be evaluated in the patients on vitamine K antagonist (VKA) treatment by measuring the time elapsed between the reading of the International Normalized Ratio (INR) by the LabPad® at patient's home and the validation of the biological measure, The time that the patient spends in his therapeutic range will be measured. The adverse events related to VKA will also be collected. At the end of the study, the patient will complete satisfaction and usage questionnaires about the LabPad®.

This study will be performed for 6 months.

Conditions

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Vitamine K Antagonist (VKA) Treatment International Normalized Ratio (INR) Measure at Home Thromboembolic Pathology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients included benefit from at home INR measure

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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At home INR measurement with LabPad®

All at home INR measurements will be performed with the LabPad® point-of-care

Group Type EXPERIMENTAL

LabPad® point-of-care

Intervention Type DEVICE

All at home INR measurements will be performed by the nurse using the LabPad® point-of-care

Interventions

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LabPad® point-of-care

All at home INR measurements will be performed by the nurse using the LabPad® point-of-care

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years of age
* Patient treated with VKA and without any heparin - VKA relay
* Patient able to read and understand the procedure, and able to express consent for the study

Exclusion Criteria

* Patient treated with heparin
* Patient treated with direct oral anticoagulants (DAOs)
* Patient with antiphospholipid antibody syndrome (APA)
* Patient not available or wishing to change region within one year of inclusion
* Patient currently participating or having participated in the month preceding the inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
* Persons referred to in Articles L.1121-5 to L.1121-8 of the French Public Health Law (corresponds to all protected persons: pregnant woman (verified by the dosage of β- human chorionic gonadotropin for any woman wishing to participate in the protocol and of childbearing age \< 60 years), parturient, nursing woman, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No