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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2026-A00022-49 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with remote monitoring | Experimental | Patients who will benefit from remote monitoring to support them in their changes to antiepileptic treatment |
|
| Patients without remote monitoring | Active Comparator | Patients who will receive standard care without remote monitoring as part of a change in anti-epileptic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote monitoring training | Other | Training in the care pathway via remote monitoring software |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after the inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months after the inclusion |
| Description of the care pathway between baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie DENUELLE, MD | Contact | 05 61 77 94 24 | +33 | denuelle.m@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cerebral electrophysiology, epilepsy and sleep, Purpan Hospital, Place du Docteur Baylac | Toulouse | Non | 31059 | France |
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| 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 |
|
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 | Patient satisfaction score on epilepsy care questionnaire | 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 | 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, | 6 months after the inclusion |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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