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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 74
- Locations
- 3
- Primary Endpoint
- Change in the "safety management" sub-scale of the Epilepsy Self Management Scale (ESMS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental group
Patients of the experimental group will have therapeutic patient education sessions that include one "Recognizing and Managing the Risks of Epilepsy" workshop.
Intervention: Risk prevention session (Procedure)
Control group "Usual management"
Patients of the "control" group will have the usual therapeutic patient education sessions.
Intervention: Usual Therapeutic Patient Education (TPE) management (Procedure)
Outcomes
Primary Outcomes
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
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 Outcomes
- Global score of Epilepsy Self Management Scale (ESMS)(From baseline to 3 months after the end of TPE)
- Medication adherence rating scale "MARS"(From baseline to 3 months after the end of TPE)
- Scores on the Generalized Anxiety Disorders Scale (GAD-7)(From baseline to 3 months after the end of TPE)
- Sub-scales of Epilepsy Self Management Scale (ESMS)(From baseline to 3 months after the end of TPE)
- Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score(From baseline to 3 months after the end of TPE)
- Questionnaire on "knowledge and assessment of risky behaviors"(From baseline to 3 months after the end of TPE)
- Seizures description(From baseline to 3 months after the end of TPE)
- Quality of Life in Epilepsy Inventory (QOLIE-31) score(From baseline to 3 months after the end of TPE)
- Frequency of seizures(From baseline to 3 months after the end of TPE)