NCT06202196

Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy

Evaluate the Impact of a Specific Risk Prevention Program Associated With a Therapeutic Patient Education Program on the Risk Behaviors of Adult Patients With Uncontrolled Epilepsy.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Pilot, controled, randomized study aiming to evaluate a plan for the prevention of risks related to epilepsy, 3 months after the last therapeutic patient education session. Two groups of patients will be compared: group "intervention" (consultation with the neurologist then a psychologist followed by a session dedicated to risk prevention ("Recognize and Manage risks") integrated into usual Therapeutic Patient Education (TPE) versus "control" group (usual consultations with the neurologist and usual TPE). 37 subjects per group will be included in this study.

Detailed description

The study will be proposed to patients with uncontrolled epilepsy (n=74) aged 18 to 40. The investigators will evaluate 3 months after the last therapeutic patient session, the impact of the epilepsy-related risk prevention system on the self-management of epilepsy ("Safety Management" score of the Epilepsy Self Management Scale (ESMS). This scale has 5 dimensions (5 sub-scores): treatment management, information management, safety management, seizure management and lifestyle management. Each clinical investigation team works in collaboration with a clinical psychologist for psychological assessment interviews. The implementation of such a plan should enable patient to acquire so-called safety skills aimed at protecting his life, reducing risky behavior and increasing medication compliance.

Conditions

• Epilepsy

Interventions

Type	Name	Description
PROCEDURE	Risk prevention session	The patient will have a consultation dedicated to information on the risks with the neurologist within 1 to 3 months (during this period, the patient must complete the seizure diary). An appointment with the psychologist within 2 weeks +/- 1 week following the risk discussion consultation will also be scheduled. In this interval of 2 weeks, the patient will have the possibility of reaching the neurologist, the psychologist or the nurse by telephone if he feels the need. Then participants will be proposed the therapeutic education session including a workshop called ""Recognizing and Managing the Risks of Epilepsy". The last visit 3 months after the last session will assess differents questionnaires/scales including the Epilepsy Self Management Scale (ESMS).
PROCEDURE	Usual Therapeutic Patient Education (TPE) management	The control group will have usual follow-up including consultations with the neurologist and follow-up of the usual TPE program, namely the individual interview and follow-up of the usual TPE workshops for each center.

Timeline

• Start date: 2024-04-16
• Primary completion: 2028-04-16
• Completion: 2028-04-16
• First posted: 2024-01-11
• Last updated: 2025-10-03

Locations

1 site across 1 country: France