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| Name | Class |
|---|---|
| AG2R La Mondiale | OTHER |
| AVALUN | UNKNOWN |
| Icadom | INDUSTRY |
| ORIADE NOVIALE |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| At home INR measurement with LabPad® | Experimental | All at home INR measurements will be performed with the LabPad® point-of-care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LabPad® point-of-care | Device | All at home INR measurements will be performed by the nurse using the LabPad® point-of-care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time in Therapeutic Range |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoire ORIADE NOVIALE | Saint-Marcellin | 38160 | France |
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| SIL-LAB INNOVATIONS | UNKNOWN |
| TASDA | UNKNOWN |
All patients included benefit from at home INR measure
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Measure of the time in hour that patient spends in his therapeutic range |
| During 6 months of use |
| Number of adverse events related to VKA | Collection of adverse events during patient follow-up | During 6 months of use |
| 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 |
| 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 |