Clincosm LogoSign in Get a demo

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

Sponsor
Medicalps (Other)
Overall Status
Completed
CT.gov ID
NCT04117048
Collaborator
AG2R La Mondiale (Other), AVALUN (Other), Icadom (Industry), ORIADE NOVIALE (Other), SIL-LAB INNOVATIONS (Other), TASDA (Other)
128
Enrollment
1
Location
1
Arm
6
Actual Duration (Months)
21.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LabPad® point-of-care
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All patients included benefit from at home INR measureAll patients included benefit from at home INR measure
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Oct 3, 2019
Actual Primary Completion Date :
Apr 3, 2020
Actual Study Completion Date :
Apr 3, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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)

  2. Time in Therapeutic Range [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 [During 6 months of use]

    Collection of adverse events during patient follow-up

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratoire ORIADE NOVIALE Saint-Marcellin France 38160

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medicalps
ClinicalTrials.gov Identifier:
NCT04117048
Other Study ID Numbers:
  • RCB 2019-A01357-50
First Posted:
Oct 7, 2019
Last Update Posted:
Apr 6, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Medicalps
INR
Labpad®
VKA

Study Results

No Results Posted as of Apr 6, 2020