International Normalized Ratio (INR) Measure at Home, Thromboembolic Pathology, Vitamine K Antagonist (VKA) Treatment
Conditions
Keywords
INR, Labpad®, VKA
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.
Interventions
DEVICELabPad® point-of-care
All at home INR measurements will be performed by the nurse using the LabPad® point-of-care
Sponsors
AG2R La Mondiale
AVALUN
Icadom
ORIADE NOVIALE
SIL-LAB INNOVATIONS
TASDA
Medicalps
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All patients included benefit from at home INR measure
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient follow up time, regardless of the value of the INR | During 6 months of use | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5) | During 6 months of use | 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) |
| Time in Therapeutic Range | During 6 months of use | Measure of the time in hour that patient spends in his therapeutic range |
| Number of adverse events related to VKA | During 6 months of use | Collection of adverse events during patient follow-up |
| Patient's satisfaction about the LabPad®: Satisfaction Questionnaire | After 6 months of use | 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. |
| LabPad® patient's use | After 6 months of 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. |
Countries
France
Outcome results
None listed