Program for preventing risks in patients with uncontrolled epilepsy
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.
This study is testing a new program to help young adults with uncontrolled epilepsy learn better self-management skills by providing extra support and education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06202196 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates a risk prevention program integrated into therapeutic patient education for individuals aged 18 to 40 with uncontrolled epilepsy. Participants will be randomly assigned to either an intervention group, which receives additional risk management consultations, or a control group that receives standard care. The study aims to assess the impact of this program on patients' self-management skills related to epilepsy three months after the last educational session. The effectiveness will be measured using the Safety Management score from the Epilepsy Self Management Scale.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 40 with poorly controlled epilepsy who are willing to participate in a therapeutic education program.
Not a fit: Patients with major cognitive impairments or those who have previously participated in a therapeutic education program may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance self-management skills and reduce risks associated with uncontrolled epilepsy.
How similar studies have performed: While similar approaches have been explored, this specific integration of risk prevention into therapeutic education is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- CHU Gui de Chauliac — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Christiane Maurin, Nurse
- Email: c-maurin@chu-montpellier.fr
- Phone: 04.67.33.78.78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.