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

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote monitoring training, Description of the standard care pathway, Therapeutic support with a nurse, Questionnaires for the two groups.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Remote monitoring training
    Training in the care pathway via remote monitoring software
  • Other Description of the standard care pathway
    Description of the standard care pathway with the nurse
  • 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

Primary outcome measures

  • Describe the evolution of therapeutic adherence [Time frame: 6 months after the inclusion]
Secondary outcome measures (5)
  • Evolution of Quality of Life between baseline and 6 months [Time frame: 6 months after the inclusion]
  • Description of the care pathway between baseline and 6 months [Time frame: 6 months after the inclusion]
  • Description of patient satisfaction with their medical care [Time frame: 6 months after the inclusion]
  • Evaluation of patient acceptability of remote monitoring [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

France · 1 center
  • Cerebral electrophysiology, epilepsy and sleep, Purpan Hospital, Place du Docteur Baylac — Toulouse

Identifiers

NCT: NCT07507240 · RC31/25/0401 · ID-RCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗