Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06202196

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Gui de Chauliac, Montpellier, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

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

    Time frame: From baseline to 3 months after the end of TPE

    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.

Secondary outcomes

  1. Global score of Epilepsy Self Management Scale (ESMS)

    Time frame: From baseline to 3 months after the end of TPE

    The total possible scores of the ESMS range from 38 to 190 with higher scores indicating greater use of self-management strategies.

  2. Sub-scales of Epilepsy Self Management Scale (ESMS)

    Time frame: From baseline to 3 months after the end of TPE

    The following subscales will be calculated : realms of medication management (10 items), information management (8 items), seizure management (6 items), and lifestyle management (6 items).

  3. Medication adherence rating scale "MARS"

    Time frame: From baseline to 3 months after the end of TPE

    The measurement of compliance will be based on the MARS scale (medication adherence rating scale) composed of 10 items. This questionnaire is one of the most widely used, particularly in the field of neuropsychiatry. This scale does not have a threshold. Items 1 to 4 correspond to treatment adherence behavior, items 5 to 8 correspond to attitude around drug intake and items 9 and 10 are reversed: negative effect of treatments and attitude towards the psychotropic drug.

  4. Scores on the Generalized Anxiety Disorders Scale (GAD-7)

    Time frame: From baseline to 3 months after the end of TPE

    Scores on the Generalized Anxiety Disorders Scale (GAD-7). The GAD-7 is a self-administered questionnaire consisting of 7 items rated from 0 to 3. The total score is obtained by adding the score obtained for each item (score ranging from 0 to 21). A total score strictly greater than 7 should raise suspicion of a generalized anxiety disorder.

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

    Time frame: From baseline to 3 months after the end of TPE

    The NDDI-E is a scale validated in French for screening major depressive episodes (characterized) in patients with epilepsy. This is a self-administered questionnaire (completed by the patient). The total score is obtained by adding the score obtained at each item. A total score strictly greater than 15 should raise suspicion of a major depressive episode. The NDDI-E is a screening scale. If the score is > 15, it is therefore advisable to have the diagnosis confirmed by a clinical psychiatric assessment.

  6. Quality of Life in Epilepsy Inventory (QOLIE-31) score

    Time frame: From baseline to 3 months after the end of TPE

    QOLIE-31 (validated French version) is an epilepsy-related quality of life scale that includes 31 items on health and daily activities (Cramer et al., 1998).

    The QOLIE-31 contains seven multi-item scales that tap the following healths concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects and overall quality of life. A QOLIE-31 overall score is obtained using a weighted average of the multi-item scale scores.

  7. Questionnaire on "knowledge and assessment of risky behaviors"

    Time frame: From baseline to 3 months after the end of TPE

    Questionnaire on "knowledge and assessment of risky behaviors" (i.e driving, risky sports, alcohol intake, sleep deprivation, bathing, swimming, burns)

  8. Frequency of seizures

    Time frame: From baseline to 3 months after the end of TPE

    Frequency of seizures will be recorded on a patient diary

  9. Seizures description

    Time frame: From baseline to 3 months after the end of TPE

    Seizures decription will be recorded on a patient diary

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Catheland, Nurse

CONTACT

[email protected]

+33 4.67.33.78.78

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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.

Acronym: EPI-RISK

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 11, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.