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

March 27, 2026 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Non
      • Toulouse, Non, France, 31059
        • Cerebral electrophysiology, epilepsy and sleep, Purpan Hospital, Place du Docteur Baylac
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with remote monitoring
Patients who will benefit from remote monitoring to support them in their changes to antiepileptic treatment
Other: Remote monitoring training
Training in the care pathway via remote monitoring software
Other: 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
Diagnostic test: Questionnaires for the two groups
Quality of life questionnaires at baseline and at 6 months
Other: Satisfaction questionnaire for the group with remote monitoring
Satisfaction questionnaire for the group with remote monitoring at 6 months
Active Comparator: Patients without remote monitoring
Patients who will receive standard care without remote monitoring as part of a change in anti-epileptic treatment
Diagnostic test: Questionnaires for the two groups
Quality of life questionnaires at baseline and at 6 months
Other: Description of the standard care pathway
Description of the standard care pathway with the nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the evolution of therapeutic adherence
Time Frame: 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.
6 months after the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of Quality of Life between baseline and 6 months
Time Frame: 6 months after the inclusion
Evolution of the score on the QOLIE 31 quality of life scale between the beginning and the end of the course between 2 groups
6 months after the inclusion
Description of the care pathway between baseline and 6 months
Time Frame: 6 months after the inclusion
Description of the number of consultations in both groups between baseline and 6 months
6 months after the inclusion
Description of patient satisfaction with their medical care
Time Frame: 6 months after the inclusion
Patient satisfaction score on epilepsy care questionnaire
6 months after the inclusion
Evaluation of patient acceptability of remote monitoring
Time Frame: 6 months after the inclusion
Patient satisfaction questionnaire score regarding the use of the digital tool for the group of patients who received care via remote monitoring
6 months after the inclusion
Evaluation of satisfaction with the use of remote monitoring by the healthcare team
Time Frame: 6 months after the inclusion
Score on the satisfaction questionnaire regarding the use of remote monitoring by the care team,
6 months after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/25/0401
  • ID-RCB (Other Identifier: 2026-A00289-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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