International Normalized Ratio (INR) Measure at Home Clinical Trial
— INRADOMOfficial 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
| Verified date | February 2020 |
| Source | Medicalps |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 128 |
| Est. completion date | April 3, 2020 |
| Est. primary completion date | April 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 ß- 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Laboratoire ORIADE NOVIALE | Saint-Marcellin |
| Lead Sponsor | Collaborator |
|---|---|
| Medicalps | AG2R La Mondiale, AVALUN, Icadom, ORIADE NOVIALE, SIL-LAB INNOVATIONS, TASDA |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Time in Therapeutic Range | Measure of the time in hour that patient spends in his therapeutic range | During 6 months of use | |
| Secondary | Number of adverse events related to VKA | Collection of adverse events during patient follow-up | During 6 months of use | |
| Secondary | 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 | |
| Secondary | 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 |