Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Risk prevention session, Usual Therapeutic Patient Education (TPE) management.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Change in the "safety management" sub-scale of the Epilepsy Self Management Scale (ESMS) [Time frame: From baseline to 3 months after the end of TPE]
Secondary outcome measures (9)
- Global score of Epilepsy Self Management Scale (ESMS) [Time frame: From baseline to 3 months after the end of TPE]
- Sub-scales of Epilepsy Self Management Scale (ESMS) [Time frame: From baseline to 3 months after the end of TPE]
- Medication adherence rating scale "MARS" [Time frame: From baseline to 3 months after the end of TPE]
- Scores on the Generalized Anxiety Disorders Scale (GAD-7) [Time frame: From baseline to 3 months after the end of TPE]
- Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score [Time frame: From baseline to 3 months after the end of TPE]
- Quality of Life in Epilepsy Inventory (QOLIE-31) score [Time frame: From baseline to 3 months after the end of TPE]
- Questionnaire on "knowledge and assessment of risky behaviors" [Time frame: From baseline to 3 months after the end of TPE]
- Frequency of seizures [Time frame: From baseline to 3 months after the end of TPE]
- Seizures description [Time frame: From baseline to 3 months after the end of TPE]
Eligibility criteria
Inclusion criteria
- Patient between 18 and 60 years old
- Patient with poorly controlled epilepsy (persistence of seizures evolving for more than a year despite proper treatment) or patient seizure-free for over a year but for whom therapeutic patient education (TPE) would be beneficial according to the investigator..
- 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 under guardianship or legal protection (safeguard of justice)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 2 centers
- CHU Gui de Chauliac — Montpellier
- CHU de Toulouse — Toulouse
Identifiers
NCT: NCT06202196 · RECHMPL18_0196