Laboratoire ORIADE NOVIALE
Saint-Marcellin, 38160, France
NCT Number: NCT04117048
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Saint-Marcellin, 38160, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All at home INR measurements will be performed by the nurse using the LabPad® point-of-care
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
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)
Time frame: During 6 months of use
Measure of the time in hour that patient spends in his therapeutic range
Time frame: During 6 months of use
Collection of adverse events during patient follow-up
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.
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.
Medicalps
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07570511
Antiphospholipid Syndrome, Autoimmune Diseases
Vandœuvre-lès-Nancy, France
View Trial Details