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

NCT06202196 | Recruiting

• 1 other identifier: RECHMPL18_0196
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy; Therapeutic Patient Education

Outcome Measures

Primary Outcomes (1)

• Change in the "safety management" sub-scale of the Epilepsy Self Management Scale (ESMS)

  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.

  From baseline to 3 months after the end of TPE

Secondary Outcomes (9)

• Global score of Epilepsy Self Management Scale (ESMS)

  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

• 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

• Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score

  From baseline to 3 months after the end of TPE

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Procedure: Risk prevention session

Control group "Usual management"

OTHER

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

Procedure: Usual Therapeutic Patient Education (TPE) management

Interventions

Risk prevention session 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).

Experimental group

Usual Therapeutic Patient Education (TPE) management 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.

Control group "Usual management"

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Gui de Chauliac

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Christiane Maurin, Nurse

CONTACT

04.67.33.78.78; c-maurin@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical study is a multicenter, open-label, randomized in two parallel groups of patients: an experimental group "specific plan for the prevention of risks related to epilepsy" and a control group "usual consultations with the neurologist and the usual TPE sessions

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 11, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): April 16, 2028
• Study Completion (Estimated): April 16, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (1)