电话随访程序对心因性非癫痫发作生活质量的评价 (EDUQ-CPNE)
2016年3月7日 更新者:Central Hospital, Nancy, France
Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques。
本研究的目的是评估电话随访方法与传统填充方法相比的有效性。
研究概览
详细说明
本研究是一项多中心、非药物治疗和随机研究试验,将一组集成电话监控设备的患者(DST 组)与以常规方式护理患者的对照组进行比较。
课题招募方式:
研究人群代表患者诊断,通过视频脑电图确认 PNES,记录在癫痫中心和不同的 CHU,并以标准化方式告知 PNES 诊断。
患者是在住院期间招募的,视频脑电图是在耐药性癫痫的部分诊断检查中进行的,或阵发性未确定的示范,这可能被证明是 PNES。
平时护理:
PNES 诊断后:定向精神病护理或 CMP 自由,每半年与神经科医生会面一次。
在研究中:
- 对于两组患者:管理常规护理,此外,在与神经科医生预约后的 24 个月内,由神经心理学家每半年进行一次生活质量和评估问卷调查。
- 仅适用于 DST 组患者:第 15 个月、第 2 个月、然后每 2 个月一次,直到第 12 个月由心理学家打电话。 设备电话跟踪 (DST) 包括外部独立心理学家对患者的电话呼叫(D15、M2,然后每 2 个月一次,直到 M12),旨在告知患者其病理,促进对诊断的接受,支持患者在他的鼓励精神病学观察的护理方法。 该设备不能替代推荐的精神科咨询。
研究类型
介入性
注册 (预期的)
136
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Louis MAILLARD, PU-PH, HDR
- 电话号码:+33 03 83 85 16 86
- 邮箱:l.maillard@chu-nancy.fr
研究联系人备份
- 姓名:Coraline HINGRAY, PU-PH
- 电话号码:+33 03 83 85 16 86
- 邮箱:c.hingray@chu-nancy.fr
学习地点
-
-
Alsace
-
Strasbourg、Alsace、法国、67 098
- 招聘中
- CHU Strasbourg
-
接触:
- Edouard HIRSCH, MD PHD
- 电话号码:+33 03 88 11 67 68
- 邮箱:Edouard.hirsch@chru-strasbourg.fr
-
接触:
- Pierre VIDAILHET, MD PHD
- 电话号码:+33 03 88 11 67 68
- 邮箱:Pierre.VIDAILHET@chru-strasbourg.fr
-
-
Bourgogne
-
Dijon、Bourgogne、法国、21 079
- 招聘中
- CHU Dijon
-
接触:
- Martine LEMESLE, MD
- 电话号码:+33 03 80 29 37 54
- 邮箱:martine.lemesle@chu-dijon.fr
-
接触:
- Benoît TROJAK, MD PHD
- 电话号码:+33 03 80 29 37 54
- 邮箱:benoit.trojak@chu-dijon.fr
-
-
Champagne Ardennes
-
Reims、Champagne Ardennes、法国、51 092
- 招聘中
- CHU Reims
-
接触:
- Anne THIRIAUX, MD
- 电话号码:+33 03 26 78 71 34
- 邮箱:thiriauxanne@hotmail.com
-
接触:
- Delphine RAUCHER CHENE, MD
- 电话号码:+33 03 26 78 71 34
- 邮箱:draucherchene@chu-reims.fr
-
副研究员:
- Jean François VISSEAUX, MD
-
-
Lorraine
-
Nancy、Lorraine、法国、54 035
- 招聘中
- Chu Nancy
-
接触:
- Louis MAILLARD, MD PHD
- 电话号码:+33 03 83 85 16 86
- 邮箱:l.maillard@chu-nancy.fr
-
接触:
- Coraline HINGRAY, MD
- 电话号码:+33 03 83 85 16 86
- 邮箱:c.hingray@chu-nancy.fr
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准:
- 18岁以上患者
- 加入社会保障
- 超过三个月的进化障碍,至少有 3 次间隔超过 24 小时且少于两年的心因性非癫痫发作
- PNES 的诊断(与癫痫相关或无关)或在视频脑电图检查后确诊
- 神经科医生参与者/PHRC 培训对疾病的标准化宣告
- 良好的法语理解
- 患者同意参加研究
排除标准:
- 纳入时的急性精神病理学需要紧急住院治疗(急性自杀风险,表妄想......)
- 在研究期间容易加重的进行性神经病理学并发(神经胶质瘤,多发性硬化症,痴呆......)
- 身体不能遵守研究者酌情决定的每六个月一次审查的患者(计划搬迁......)
- 在前 12 个月内同时参与另一项治疗干预研究
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:电话跟进装置(DST)
外部独立临床心理学家负责定期致电 DST 组中的患者。 电话随访装置 (DST) 包括在第 15 天、第 2 个月、然后每 2 个月一次直到第 12 个月进行一次电话随访。 临床心理学家旨在告知患者其病理,促进对诊断的接受,支持患者的护理方法,鼓励精神病学观察。 该设备不能替代推荐的精神科咨询。 |
仅针对 DST 组中的患者:临床心理学家在 J 15 2 点打来电话,然后每 2 个月打一次电话,直到 M12。
|
无干预:群控;日常护理
- 常规护理:PNES 诊断后:定向精神病护理或 CMP 自由,每半年与神经科医生会面 - 对于两组患者:此外,在与神经科医生预约后的 24 个月内,神经心理学家每半年进行一次生活质量问卷和评估。 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
每 6 个月(从 6 到 24 个月)生活质量评分的演变
大体时间:24个月
|
主要终点是在治疗开始后 6、12、18 和 24 个月(访视 D0)通过自填生活质量问卷(SF-36 生活质量一般问卷)和 QOLIE 评估生活质量评分31(特定问卷癫痫)。
|
24个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
每月非癫痫发作的频率
大体时间:24个月(平均6个月)
|
癫痫发作日记如下
|
24个月(平均6个月)
|
癫痫发作的严重程度
大体时间:24个月
|
在 EVA 量表危机控制感觉上,0 到 10 之间列出的危机的持续时间、受伤、尿液和粪便流失、跌倒、意识丧失和主观控制感。
|
24个月
|
精神症状学评分
大体时间:24个月
|
调查问卷(DSM-IV、Beck 21、MADRS、HAMA、DES、SDQ-20、TAS 20、Brief COPE)
|
24个月
|
在医学和心理中心进行的计划心理咨询和实际兑现的百分比
大体时间:24个月
|
这个百分比是在医学和心理中心或从自由精神科医生\心理学家那里收集的(通过电话收集)
|
24个月
|
紧急咨询或未编程和\或未编程的次数
大体时间:24个月
|
会诊(SAMU、紧急情况、复苏、未编程的神经病学会诊)。
|
24个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Louis MAILLARD, PU-PH, HDR、Central Hospital, Nancy, France
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (预期的)
2018年1月1日
研究完成 (预期的)
2018年1月1日
研究注册日期
首次提交
2014年10月28日
首先提交符合 QC 标准的
2014年12月5日
首次发布 (估计)
2014年12月8日
研究记录更新
最后更新发布 (估计)
2016年3月8日
上次提交的符合 QC 标准的更新
2016年3月7日
最后验证
2016年3月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.