EpilepsyEPI-RISKNCT06202196
Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy
A study testing Risk prevention session and Usual Therapeutic Patient Education (TPE) management in people with Epilepsy, run by University Hospital, Montpellier at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Risk prevention session and Usual Therapeutic Patient Education (TPE) management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2024to 16 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Gui de Chauliac
Montpellier
Alice Catheland, Nurse, +33 4.67.33.78.78, a-catheland@chu-montpellier.Fr
- Recruiting
CHU de Toulouse
Toulouse
Marie Denuelle, MD, +33 5.61.77.94.88, denuelle.m@chu-toulouse.fr
About this study
Official 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.
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.
Read the 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
- Being tested
- Risk prevention session, Usual Therapeutic Patient Education (TPE) management
- Keywords
- Epilepsy, Therapeutic Patient Education
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk prevention sessionProcedure or surgery
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) managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Risk prevention session |
| Control group "Usual management" | Other | Patients of the "control" group will have the usual therapeutic patient education sessions. Receives: Procedure: Usual Therapeutic Patient Education (TPE) management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 3 months after the end of TPE
Secondary outcomes (9)
Global score of Epilepsy Self Management Scale (ESMS)
The total possible scores of the ESMS range from 38 to 190 with higher scores indicating greater use of self-management strategies.
Measured: From baseline to 3 months after the end of TPE
Sub-scales of Epilepsy Self Management Scale (ESMS)
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).
Measured: From baseline to 3 months after the end of TPE
Medication adherence rating scale "MARS"
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.
Measured: From baseline to 3 months after the end of TPE
Scores on the Generalized Anxiety Disorders Scale (GAD-7)
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.
Measured: From baseline to 3 months after the end of TPE
Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score
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.
Measured: From baseline to 3 months after the end of TPE
Quality of Life in Epilepsy Inventory (QOLIE-31) score
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.
Measured: From baseline to 3 months after the end of TPE
Questionnaire on "knowledge and assessment of risky behaviors"
Questionnaire on "knowledge and assessment of risky behaviors" (i.e driving, risky sports, alcohol intake, sleep deprivation, bathing, swimming, burns)
Measured: From baseline to 3 months after the end of TPE
Frequency of seizures
Frequency of seizures will be recorded on a patient diary
Measured: From baseline to 3 months after the end of TPE
Seizures description
Seizures decription will be recorded on a patient diary
Measured: From baseline to 3 months after the end of TPE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start16 Apr 2024
- Primary completion16 Apr 2028 (estimated)
- Study completion16 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202196
- Sponsor's protocol ID
- RECHMPL18_0196
- Acronym
- EPI-RISK
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06202196
- Acronym / sponsor ID
- EPI-RISK / RECHMPL18_0196
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Therapeutic Patient Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 16 Apr 2028 (estimated)
- Study completion
- 16 Apr 2028 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Risk prevention sessionPatients of the experimental group will have therapeutic patient education sessions that include one "Recognizing and Managing the Risks of Epilepsy" workshop. |
| Control group "Usual management" | Other | Procedure: Usual Therapeutic Patient Education (TPE) managementPatients of the "control" group will have the usual therapeutic patient education sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk prevention sessionThe 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). | Procedure or surgery | Experimental group |
| Usual Therapeutic Patient Education (TPE) managementThe 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. | Procedure or surgery | Control group "Usual management" |
Primary outcome
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.
9 secondary outcomes
Global score of Epilepsy Self Management Scale (ESMS)
Time frame: From baseline to 3 months after the end of TPE
Sub-scales of Epilepsy Self Management Scale (ESMS)
Time frame: From baseline to 3 months after the end of TPE
Medication adherence rating scale "MARS"
Time frame: From baseline to 3 months after the end of TPE
Scores on the Generalized Anxiety Disorders Scale (GAD-7)
Time frame: From baseline to 3 months after the end of TPE
Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score
Time frame: From baseline to 3 months after the end of TPE
Quality of Life in Epilepsy Inventory (QOLIE-31) score
Time frame: From baseline to 3 months after the end of TPE
Questionnaire on "knowledge and assessment of risky behaviors"
Time frame: From baseline to 3 months after the end of TPE
Frequency of seizures
Time frame: From baseline to 3 months after the end of TPE
Seizures description
Time frame: From baseline to 3 months after the end of TPE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk prevention session and Usual Therapeutic Patient Education (TPE) management in people with Epilepsy, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Catheland, Nurse (+33 4.67.33.78.78, a-catheland@chu-montpellier.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.