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Completed

NCT Number: NCT04117048

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratoire ORIADE NOVIALE

Saint-Marcellin, 38160, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LabPad® point-of-care

Device

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

Primary outcomes

  1. Patient follow up time, regardless of the value of the INR

    Time frame: 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 outcomes

  1. Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5)

    Time frame: 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)

  2. Time in Therapeutic Range

    Time frame: During 6 months of use

    Measure of the time in hour that patient spends in his therapeutic range

  3. Number of adverse events related to VKA

    Time frame: During 6 months of use

    Collection of adverse events during patient follow-up

  4. Patient's satisfaction about the LabPad®: Satisfaction Questionnaire

    Time frame: 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.

  5. LabPad® patient's use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medicalps

Other

Collaborators

  • AG2R La Mondiale
  • AVALUN
  • Icadom
  • ORIADE NOVIALE
  • SIL-LAB INNOVATIONS
  • TASDA

Registry information

Official study 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

Acronym: INRADOM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2019
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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