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Clinical Trials in France / NCT07507240
Starting soon Not applicable

The Benefits of a Care Pathway Combining Remote Monitoring and Support From a Nurse After a Change in Anti-epileptic Treatment: a Pilot Study

NCT07507240 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Toulouse
Phase
Not applicable
Started
2026-05-01
Last updated
2026-04-02

Condition(s) studied

Epilepsy

Investigational drug(s) / intervention(s)

Remote monitoring trainingDescription of the standard care pathwayTherapeutic support with a nurseQuestionnaires for the two groupsSatisfaction questionnaire for the group with remote monitoring

Remote monitoring training: Training in the care pathway via remote monitoring software

Description of the standard care pathway: Description of the standard care pathway with the nurse

Therapeutic support with a nurse: Therapeutic support with a nurse who ensures the patient's adherence to remote monitoring at 1 month and 3 months

Questionnaires for the two groups: Quality of life questionnaires at baseline and at 6 months

Satisfaction questionnaire for the group with remote monitoring: Satisfaction questionnaire for the group with remote monitoring at 6 months

Study summary

Epilepsy is a chronic condition affecting approximately 600,000 people in France. Epilepsy treatment relies on antiepileptic drugs, the effectiveness of which depends on adherence to medication schedule, with missed doses increasing the risk of seizures. As with any chronic illness, epilepsy presents a significant challenge in terms of treatment adherence. Furthermore, despite good medication adherence, 30% of patients remain drug-resistant.

Therefore, the aim is to create a remote monitoring program, supported by a nurse, lasting six months after the introduction of a new antiepileptic drug, to support the patient until their next appointment with a neurologist. This system would optimize and secure the care pathway during treatment changes by improving the detection of side effects and/or a resurgence of seizures requiring medication adjustments.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Confirmed diagnosis of epilepsy by a neurologist * Patient requiring the introduction of anti-epileptic medication as an add-on to their usual treatment or as a replacement for their current treatment(s) * Access to a reliable internet connection and a compatible device for remote monitoring (smartphone, tablet, computer) * Ability to understand and use remote communication technologies Exclusion Criteria: * Presence of concurrent neurological or psychiatric disorders affecting the ability to use remote monitoring. * Presence of a progressive neurological disease, including degenerative CNS disease, or a progressive tumor. * Change in treatment for pregnancy preparation.

Primary outcome measure(s)

  • Describe the evolution of therapeutic adherence — 6 months after the inclusion
    Measurement of the Mascard scale score in 2 groups of patients benefiting or not from the new care and support pathway.

Trial sites (1)

FacilityCityRegionStatus
Cerebral electrophysiology, epilepsy and sleep, Purpan Hospital, Place du Docteur Baylac Toulouse Non

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Other trials for the same condition

Study of the Link Between Structural Alterations in the Hypothalamus and Cardiac Dysautonomia in Drug-resistant Epilepsy Recruiting
RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy Recruiting
Evaluation of the Incidence of Psychiatric Disorders As a Function of First-line Antiepileptic Drug Prescribing Practices: Use of Assurance Maladie Databases Starting soon
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07507240 on ClinicalTrials.gov ↗ ← All trials in France