INRADOM
Background
In France, almost a million people are treated with vitamin K antagonist (VKA) drugs as first-line prevention or treatment for thromboembolic disorders.
Finding the optimal dosage of these treatments is complex because of the large variation in responses to VKA doses depending on the individuals, as well as a high risk of drug and food interactions. Monthly biological monitoring by measurement of the INR (International Normalized Ratio) is therefore essential.
The current reference method involves measuring INR levels from a blood sample taken in a medical analysis laboratory. The results are then sent to the doctor, who adjusts the treatment. However, INR levels are out with the target range for over 50% of individuals.
Therefore, the aim of the INRADOM project was to use digital innovation to create a new, connected care pathway to enable simplified, reliable and rapid management of people on VKA.
Promotor
MEDICALPS
Project coordination
IC@dom
Type of study
Interventional / Clinical investigation in the home
Multicentre trial
Sample size
200 patients
Study design
To achieve this objective, nurses visited the homes of people taking VKA with a LabPad®: a portable in vitro diagnostic medical device (IVDD) and Point of Care (connected directly to the medical biology laboratory’s information system.
The primary aim was to assess the impact of using LabPad® on management time.
IC@dom was commissioned to provide comprehensive support to the MEDICALPS teams at every stage of the clinical investigation:
Project design and management
Drafting the protocol
Drafting the e-CRF (electronic case report form)
Project coordination
Statistical analysis of data
Results
This study showed that use of the Labpad® reduced the median management time to 1 hour 53 minutes, compared with a median time of 3 hours 30 minutes for the reference management method.
1h53
Reduced the median management time
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