EpilepsyEPISURNCT07507240
The Benefits of a Care Pathway Combining Remote Monitoring and Support From a Nurse After a Change in Anti-epileptic Treatment: a Pilot Study
A study testing Remote monitoring training, Therapeutic support with a nurse and Questionnaires for the two groups in people with Epilepsy, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Remote monitoring training, Therapeutic support with a nurse and Questionnaires for the two groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Cerebral electrophysiology, epilepsy and sleep, Purpan Hospital, Place du Docteur Baylac
Toulouse, Non, 31059
Emeline MULLER, 0561778707 ext. +33, muller.e@chu-toulouse.Fr
About this study
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
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.
- Conditions
- Epilepsy
- Being tested
- Remote monitoring training, Description of the standard care pathway, Therapeutic support with a nurse, Questionnaires for the two groups, Satisfaction questionnaire for the group with remote monitoring
- Keywords
- epilepsy, remote monitoring, epilepsy treatment
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoring trainingOther
Training in the care pathway via remote monitoring software
Description of the standard care pathwayOther
Description of the standard care pathway with the nurse
Therapeutic support with a nurseOther
Therapeutic support with a nurse who ensures the patient's adherence to remote monitoring at 1 month and 3 months
Questionnaires for the two groupsDiagnostic test
Quality of life questionnaires at baseline and at 6 months
Satisfaction questionnaire for the group with remote monitoringOther
Satisfaction questionnaire for the group with remote monitoring at 6 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with remote monitoring | Experimental | Patients who will benefit from remote monitoring to support them in their changes to antiepileptic treatment Receives: Other: Remote monitoring training; Other: Therapeutic support with a nurse; Diagnostic Test: Questionnaires for the two groups; Other: Satisfaction questionnaire for the group with remote monitoring |
| Patients without remote monitoring | Active comparator | Patients who will receive standard care without remote monitoring as part of a change in anti-epileptic treatment Receives: Other: Description of the standard care pathway; Diagnostic Test: Questionnaires for the two groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the evolution of therapeutic adherence
Measurement of the Mascard scale score in 2 groups of patients benefiting or not from the new care and support pathway.
Measured: 6 months after the inclusion
Secondary outcomes (5)
Evolution of Quality of Life between baseline and 6 months
Evolution of the score on the QOLIE 31 quality of life scale between the beginning and the end of the course between 2 groups
Measured: 6 months after the inclusion
Description of the care pathway between baseline and 6 months
Description of the number of consultations in both groups between baseline and 6 months
Measured: 6 months after the inclusion
Description of patient satisfaction with their medical care
Patient satisfaction score on epilepsy care questionnaire
Measured: 6 months after the inclusion
Evaluation of patient acceptability of remote monitoring
Patient satisfaction questionnaire score regarding the use of the digital tool for the group of patients who received care via remote monitoring
Measured: 6 months after the inclusion
Evaluation of satisfaction with the use of remote monitoring by the healthcare team
Score on the satisfaction questionnaire regarding the use of remote monitoring by the care team,
Measured: 6 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507240
- Sponsor's protocol ID
- RC31/25/0401
- Other IDs
- ID-RCB
- Acronym
- EPISUR
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07507240
- Acronym / sponsor ID
- EPISUR / RC31/25/0401
- Conditions
- Epilepsy
- Keywords
- epilepsy, remote monitoring, epilepsy treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with remote monitoring | Experimental | Other: Remote monitoring training, Other: Therapeutic support with a nurse, Diagnostic Test: Questionnaires for the two groups, Other: Satisfaction questionnaire for the group with remote monitoringPatients who will benefit from remote monitoring to support them in their changes to antiepileptic treatment |
| Patients without remote monitoring | Active comparator | Other: Description of the standard care pathway, Diagnostic Test: Questionnaires for the two groupsPatients who will receive standard care without remote monitoring as part of a change in anti-epileptic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote monitoring trainingTraining in the care pathway via remote monitoring software | Other | Patients with remote monitoring |
| Description of the standard care pathwayDescription of the standard care pathway with the nurse | Other | Patients without remote monitoring |
| Therapeutic support with a nurseTherapeutic support with a nurse who ensures the patient's adherence to remote monitoring at 1 month and 3 months | Other | Patients with remote monitoring |
| Questionnaires for the two groupsQuality of life questionnaires at baseline and at 6 months | Diagnostic test | Patients with remote monitoring, Patients without remote monitoring |
| Satisfaction questionnaire for the group with remote monitoringSatisfaction questionnaire for the group with remote monitoring at 6 months | Other | Patients with remote monitoring |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote monitoring training, Therapeutic support with a nurse and Questionnaires for the two groups in people with Epilepsy, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie DENUELLE, MD (05 61 77 94 24 ext. +33, denuelle.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the evolution of therapeutic adherence (time frame: 6 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.