Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 136
- 试验地点
- 8
- 主要终点
- Evolution of quality of life scores every 6 months (From 6 to 24 months)
研究概览
简要总结
The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.
详细描述
This study is a multicenter, non-drug therapy and randomized research trial, comparing a group of patients integrating the phone monitoring device (DST group) to a control group where patients are cared for in the usual way.
Subject recruiting modalities:
The study population represents patients diagnosis, PNES confirmed by following by the video-EEG, recorded in a center of epilepsy and in different CHU and informed of the diagnosis of PNES in a standardized manner.
Patients were recruited during their hospitalization video-EEG is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be PNES.
Usual care:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient above 18 years old
- •Affiliation to social security
- •Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years
- •Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination
- •Standardized announcement of the disease made by a neurologist participant / PHRC training
- •Good understanding of the French language
- •Patient consented to participate in the study
排除标准
- •Acute psychiatric pathology at the time of inclusion warranting urgent hospitalization (acute suicidal risk, Table delusional ...)
- •Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...)
- •A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...)
- •Simultaneous participation to another therapeutic intervention study during the first 12 months
结局指标
主要结局
Evolution of quality of life scores every 6 months (From 6 to 24 months)
时间窗: 24 months
The primary endpoint is the assessment of quality of life scores measured at 6, 12, 18 and 24 months after start of treatment (visit D0) by self-administered questionnaires of quality of life (SF-36 general questionnaire quality of life) and QOLIE 31 (specific questionnaire epilepsy).
次要结局
- Severity of seizures(24 months)
- Number of urgent consultations or unprogrammed and \ or unprogrammed(24 months)
- Frequency of non epileptic seizures per month(24 months (average for 6 months))
- Psychiatric symptomology scores(24 months)
- Percentage of programmed psychological consultation and actually honored in medical and psychological center(24 months)