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

ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Risk prevention session

    Procedure/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) management

    Procedure/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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control group "Usual management"Other 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From baseline to 3 months after the end of TPE
2

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).

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

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.

Time frame
From baseline to 3 months after the end of TPE
4

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.

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

Other outcomes

Sponsors and contacts

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