The Benefits of a Care Pathway Combining Remote Monitoring and Support From a Nurse After a Change in Anti-epileptic Treatment: a Pilot Study
NCT07507240 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-02
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.
Conditions
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
Sponsors & Collaborators
-
University Hospital, Toulouse
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2027-11-01
- Completion
- 2028-05-01
Countries
- France
Study Locations
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