Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy

NCT ID: NCT06202196

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2028-04-16

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental group

Patients of the experimental group will have therapeutic patient education sessions that include one "Recognizing and Managing the Risks of Epilepsy" workshop.

Group Type: EXPERIMENTAL

Risk prevention session

Intervention Type: PROCEDURE

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 be proposed the therapeutic education session including a workshop called ""Recognizing and Managing the Risks of Epilepsy". The last visit 3 months after the last session will assess differents questionnaires/scales including the Epilepsy Self Management Scale (ESMS).

Control group "Usual management"

Patients of the "control" group will have the usual therapeutic patient education sessions.

Group Type: OTHER

Usual Therapeutic Patient Education (TPE) management

Intervention Type: PROCEDURE

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.

Interventions

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 be proposed the therapeutic education session including a workshop called ""Recognizing and Managing the Risks of Epilepsy". The last visit 3 months after the last session will assess differents questionnaires/scales including the Epilepsy Self Management Scale (ESMS).

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Gui de Chauliac

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christiane Maurin, Nurse

Role: CONTACT

c-maurin@chu-montpellier.fr

04.67.33.78.78

Facility Contacts

Christiane Maurin, Nurse

Role: primary

c-maurin@chu-montpellier.fr

04.67.33.78.78

Other Identifiers

RECHMPL18_0196

Identifier Type: -

Identifier Source: org_study_id