Epilepsy
Conditions
Keywords
epilepsy, remote monitoring, epilepsy treatment
Brief 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. 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
OTHERRemote monitoring training
Training in the care pathway via remote monitoring software
OTHERDescription of the standard care pathway
Description of the standard care pathway with the nurse
OTHERTherapeutic 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_TESTQuestionnaires for the two groups
Quality of life questionnaires at baseline and at 6 months
OTHERSatisfaction questionnaire for the group with remote monitoring
Satisfaction questionnaire for the group with remote monitoring at 6 months
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Describe the evolution of therapeutic adherence | 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
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Quality of Life between baseline and 6 months | 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 |
| Description of the care pathway between baseline and 6 months | 6 months after the inclusion | Description of the number of consultations in both groups between baseline and 6 months |
| Description of patient satisfaction with their medical care | 6 months after the inclusion | Patient satisfaction score on epilepsy care questionnaire |
| Evaluation of patient acceptability of remote monitoring | 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 |
| Evaluation of satisfaction with the use of remote monitoring by the healthcare team | 6 months after the inclusion | Score on the satisfaction questionnaire regarding the use of remote monitoring by the care team, |
Countries
France
Contacts
CONTACTMarie DENUELLE, MD
Outcome results
None listed