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

Study Overview
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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.

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.

Official Title
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Evaluation of the Impact of Using LabPad® Point-of-care to Measure International Normalized Ratio (INR) at Home on the Patient's Follow up on VKA

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

Intervention / Treatment
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* Device: LabPad® point-of-care


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All patients included benefit from at home INR measure
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: At home INR measurement with LabPad®<br>All at home INR measurements will be performed with the LabPad® point-of-care | Device: LabPad® point-of-care<br>* All at home INR measurements will be performed by the nurse using the LabPad® point-of-care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient follow up time, regardless of the value of the INR | Measure of time in minute elapsed between the reading of the INR by the LabPad® and the validation of the biological measure, regardless of the value of the INR | During 6 months of use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5) | Measure of time in minute elapsed between the reading of the INR by the LabPad® and the validation of the biological measure, in case of INR outside the safety interval (≤1,8 or ≥5) | During 6 months of use | 
| Time in Therapeutic Range | Measure of the time in hour that patient spends in his therapeutic range | During 6 months of use | 
| Number of adverse events related to VKA | Collection of adverse events during patient follow-up | During 6 months of use | 
| Patient's satisfaction about the LabPad®: Satisfaction Questionnaire | The patient will complete a Satisfaction Questionnaire at the end of the study. This is a questionnaire made by ourselves of 9 questions with 7 submissions and the total score will be into a value ranging from the worst satisfaction 7 to the best satisfaction 63. | After 6 months of use | 
| LabPad® patient's use | The patient will complete a Questionnaire on the LabPad® use at the end of the study. This is a scale from 0 (no use desire) to 10 (best use desire) and demographic questions to characterise the patients. | After 6 months of use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INR, Labpad®, VKA