Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled E… (NCT06202196) | Clinical Trial Compass
RecruitingNot Applicable
Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy
France74 participantsStarted 2024-04-16
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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