Clinical trial NCT06202196: Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Therapeutic Patient Education
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical study is a multicenter, open-label, randomized in two parallel groups of patients: an experimental group "specific plan for the prevention of risks related to epilepsy" and a control group "usual consultations with the neurologist and the usual TPE sessions
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient between 18 and 40 years old
* Patient with poorly controlled epilepsy (persistence of seizures evolving for more than a year despite proper treatment).
* Patient agreeing to participate in a therapeutic education program (TPE)

Exclusion Criteria:

* Epileptic patient who has already benefited from a TPE epilepsy program
* Patients with major cognitive impairment
* Patient deprived of liberty by court or administrative decision, subject to a legal protection measure (guardianship or curatorship)
* Pregnant or breast-feeding women
* Failure to obtain written informed consent after a reflection period
* Patient who for geographical, social or psychological reasons could not participate in the research
* Any situation that, in the opinion of the investigator, could present risks to the patient and to the research
* Participation in another therapeutic research
* Subjects not covered by public health insurance

Primary outcomes:
measure: Change in the "safety management" sub-scale of the Epilepsy Self Management Scale (ESMS)
timeFrame: From baseline to 3 months after the end of TPE
Secondary outcomes:
measure: Global score of Epilepsy Self Management Scale (ESMS)
timeFrame: From baseline to 3 months after the end of TPE
measure: Sub-scales of Epilepsy Self Management Scale (ESMS)
timeFrame: From baseline to 3 months after the end of TPE
measure: Medication adherence rating scale "MARS"
timeFrame: From baseline to 3 months after the end of TPE
measure: Scores on the Generalized Anxiety Disorders Scale (GAD-7)
timeFrame: From baseline to 3 months after the end of TPE
measure: Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score
timeFrame: From baseline to 3 months after the end of TPE
measure: Quality of Life in Epilepsy Inventory (QOLIE-31) score
timeFrame: From baseline to 3 months after the end of TPE
measure: Questionnaire on "knowledge and assessment of risky behaviors"
timeFrame: From baseline to 3 months after the end of TPE
measure: Frequency of seizures
timeFrame: From baseline to 3 months after the end of TPE
measure: Seizures description
timeFrame: From baseline to 3 months after the end of TPE
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Gui de Chauliac
Study officials:
References: