Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy
Recruiting · NCT06202196 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Montpellier
View the official record on ClinicalTrials.gov →Interventions studied
Risk prevention sessionUsual Therapeutic Patient Education (TPE) management
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- CHU Gui de Chauliac - Montpellier, France
- CHU de Toulouse - Toulouse, France