Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy
- Conditions
- Epilepsy
- Interventions
- Procedure: Risk prevention sessionProcedure: Usual Therapeutic Patient Education (TPE) management
- Registration Number
- NCT06202196
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Risk prevention session Patients of the experimental group will have therapeutic patient education sessions that include one "Recognizing and Managing the Risks of Epilepsy" workshop. Control group "Usual management" Usual Therapeutic Patient Education (TPE) management Patients of the "control" group will have the usual therapeutic patient education sessions.
- Primary Outcome Measures
Name Time Method Change in the "safety management" sub-scale of the Epilepsy Self Management Scale (ESMS) From baseline to 3 months after the end of TPE The ESMS is a 38-item scale that assesses the frequency of use of self-management strategies in epilepsy. This scale has 5 dimensions (5 sub-scores):management of treatments, information, safety, epileptic seizures and lifestyle.
Each item can be rated from 1 (never) to 5 (always) depending on the frequency of use of self-management strategies.
- Secondary Outcome Measures
Name Time Method Global score of Epilepsy Self Management Scale (ESMS) From baseline to 3 months after the end of TPE The total possible scores of the ESMS range from 38 to 190 with higher scores indicating greater use of self-management strategies.
Medication adherence rating scale "MARS" From baseline to 3 months after the end of TPE The measurement of compliance will be based on the MARS scale (medication adherence rating scale) composed of 10 items. This questionnaire is one of the most widely used, particularly in the field of neuropsychiatry. This scale does not have a threshold. Items 1 to 4 correspond to treatment adherence behavior, items 5 to 8 correspond to attitude around drug intake and items 9 and 10 are reversed: negative effect of treatments and attitude towards the psychotropic drug.
Scores on the Generalized Anxiety Disorders Scale (GAD-7) From baseline to 3 months after the end of TPE Scores on the Generalized Anxiety Disorders Scale (GAD-7). The GAD-7 is a self-administered questionnaire consisting of 7 items rated from 0 to 3. The total score is obtained by adding the score obtained for each item (score ranging from 0 to 21). A total score strictly greater than 7 should raise suspicion of a generalized anxiety disorder.
Sub-scales of Epilepsy Self Management Scale (ESMS) From baseline to 3 months after the end of TPE The following subscales will be calculated : realms of medication management (10 items), information management (8 items), seizure management (6 items), and lifestyle management (6 items).
Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score From baseline to 3 months after the end of TPE The NDDI-E is a scale validated in French for screening major depressive episodes (characterized) in patients with epilepsy. This is a self-administered questionnaire (completed by the patient). The total score is obtained by adding the score obtained at each item. A total score strictly greater than 15 should raise suspicion of a major depressive episode. The NDDI-E is a screening scale. If the score is \> 15, it is therefore advisable to have the diagnosis confirmed by a clinical psychiatric assessment.
Questionnaire on "knowledge and assessment of risky behaviors" From baseline to 3 months after the end of TPE Questionnaire on "knowledge and assessment of risky behaviors" (i.e driving, risky sports, alcohol intake, sleep deprivation, bathing, swimming, burns)
Seizures description From baseline to 3 months after the end of TPE Seizures decription will be recorded on a patient diary
Quality of Life in Epilepsy Inventory (QOLIE-31) score From baseline to 3 months after the end of TPE QOLIE-31 (validated French version) is an epilepsy-related quality of life scale that includes 31 items on health and daily activities (Cramer et al., 1998).
The QOLIE-31 contains seven multi-item scales that tap the following healths concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects and overall quality of life. A QOLIE-31 overall score is obtained using a weighted average of the multi-item scale scores.Frequency of seizures From baseline to 3 months after the end of TPE Frequency of seizures will be recorded on a patient diary
Trial Locations
- Locations (1)
CHU Gui de Chauliac
🇫🇷Montpellier, France