Clinical trial NCT04117048: INR at Home Measurement by the LabPad® Point-of-care in Patients on Vitamin K Antagonist Drugs (VKA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamine K Antagonist (VKA) Treatment
International Normalized Ratio (INR) Measure at Home
Thromboembolic Pathology
Keywords: INR
Labpad®
VKA
Lead sponsor: Medicalps
Sponsor class: OTHER
Collaborators: name: AG2R La Mondiale
name: AVALUN
name: Icadom
name: ORIADE NOVIALE
name: SIL-LAB INNOVATIONS
name: TASDA
First posted: 2019-10-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients included benefit from at home INR measure
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient follow up time, regardless of the value of the INR
timeFrame: During 6 months of use
Secondary outcomes:
measure: Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5)
timeFrame: During 6 months of use
measure: Time in Therapeutic Range
timeFrame: During 6 months of use
measure: Number of adverse events related to VKA
timeFrame: During 6 months of use
measure: Patient's satisfaction about the LabPad®: Satisfaction Questionnaire
timeFrame: After 6 months of use
measure: LabPad® patient's use
timeFrame: After 6 months of use
Other outcomes:
Locations:
city: Saint-Marcellin
country: France
facility: Laboratoire ORIADE NOVIALE
Study officials:
References: