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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamine K Antagonist (VKA) Treatment; International Normalized Ratio (INR) Measure at Home; Thromboembolic Pathology
• Intervention / Treatment: Device: LabPad® point-of-care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Marcellin, France, 38160
    • Laboratoire ORIADE NOVIALE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: At home INR measurement with LabPad®; All at home INR measurements will be performed with the LabPad® point-of-care	Device: LabPad® point-of-care; All at home INR measurements will be performed by the nurse using the LabPad® point-of-care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medicalps
• Collaborators: Icadom; AG2R La Mondiale; AVALUN; ORIADE NOVIALE; SIL-LAB INNOVATIONS; TASDA

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2019
• Primary Completion (ACTUAL): April 3, 2020
• Study Completion (ACTUAL): April 3, 2020

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (ACTUAL): October 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: VKA; INR; Labpad®
• Other Study ID Numbers: RCB 2019-A01357-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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