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NCT Number: NCT07507240

The Benefits of a Care Pathway Combining Remote Monitoring and Support From a Nurse 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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulouse, Non, 31059, France

Location contact

Emeline MULLER

CONTACT

[email protected]

0561778707 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote monitoring training

Other

Training in the care pathway via remote monitoring software

Description of the standard care pathway

Other

Description of the standard care pathway with the nurse

Therapeutic support with a nurse

Other

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

Diagnostic Test

Quality of life questionnaires at baseline and at 6 months

Satisfaction questionnaire for the group with remote monitoring

Other

Satisfaction questionnaire for the group with remote monitoring at 6 months

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Description of patient satisfaction with their medical care

    Time frame: 6 months after the inclusion

    Patient satisfaction score on epilepsy care questionnaire

  4. 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

  5. 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,

Study contacts

Contact information is provided by the study sponsor or research team.

Marie DENUELLE, MD

CONTACT

[email protected]

05 61 77 94 24 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: EPISUR

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

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.

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