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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Change in the "safety management" sub-scale of the Epilepsy Self Management Scale (ESMS) [Срок оценки: From baseline to 3 months after the end of TPE]

Вторичные конечные точки (9)

• Global score of Epilepsy Self Management Scale (ESMS) [Срок оценки: From baseline to 3 months after the end of TPE]
• Sub-scales of Epilepsy Self Management Scale (ESMS) [Срок оценки: From baseline to 3 months after the end of TPE]
• Medication adherence rating scale "MARS" [Срок оценки: From baseline to 3 months after the end of TPE]
• Scores on the Generalized Anxiety Disorders Scale (GAD-7) [Срок оценки: From baseline to 3 months after the end of TPE]
• Neurological Disorders Depression Inventory for Epilepsie (NDDI-E) Score [Срок оценки: From baseline to 3 months after the end of TPE]
• Quality of Life in Epilepsy Inventory (QOLIE-31) score [Срок оценки: From baseline to 3 months after the end of TPE]
• Questionnaire on "knowledge and assessment of risky behaviors" [Срок оценки: From baseline to 3 months after the end of TPE]
• Frequency of seizures [Срок оценки: From baseline to 3 months after the end of TPE]
• Seizures description [Срок оценки: From baseline to 3 months after the end of TPE]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 2 центра

• CHU Gui de Chauliac — Montpellier
• CHU de Toulouse — Toulouse

Идентификаторы

NCT: NCT06202196 · RECHMPL18_0196

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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