Impact of Educational Actions on the Quality Of Life of Epileptic Patients (EQOLE)
研究概览
详细说明
Introduction:
Epilepsy is a common neurological disease with an estimated annual incidence of 43 cases per 100,000 population in developed countries (McHugh et al;. 2008). It is a chronic disease that can be disabling for the patient and his family. The management of patients with epilepsy must consider the quality of life, improving the quality of life is precisely one of the main objectives of therapeutic education (WHO1996).
Background and rational of the study:
The Epilepsy Patient Education (EPE) is very important for the comprehension of the disease and its management. By offering a better knowledge about the disease, helping the patients to learn how to manage crises and treatments, and especially, how to develop strategies to adapt to specific life situations, the EPE allows patients and caregivers to acquire together some autonomy and some skills that will help them live better with the disease.
Objectives:
The primary objective of this study is to evaluate the impact of a program of educational activities (EA) on the quality of life of epileptic patients measured by the validated scale Quality Of Life in Epilepsy -31 (QOLIE-31).
The secondary objectives are to study the evolution of knowledge of patients, to compare the frequency of crises and seeking care before and after the program, and to study the role of certain characteristics of the patient and his disease on response to the program.
Methodology:
This is a single-center, randomized, open, comparative, and longitudinal study with a duration of approximately 30 months, including 80 patients.
Patients eligible to the study will be screened among epileptic patients followed-up by the neurologists specialized in epilepsy at the University Hospital of Caen. Patients should be major with an epileptic disease diagnosed for at least 6 months without other disabling chronic condition.
Each pre-included patient will receive written information about the study. During the usual visit to the neurologist, a detailed letter of information about the study will be given to the patient and the various criteria will be evaluated. After randomization, patients will be divided into 2 groups: the first (EA group) will be included in the program of educational activities, while the second, control group (C group) will have a "standard" follow-up. An individual educational session and 3 group educational sessions (5-6 patients per group) built around the epileptic disease, its treatment and daily life, will constitute the program of EA group.
Six months after inclusion, during the usual visit, the various criteria will be reassessed with the patient, to evaluate the degree of benefice of EA.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Caen、法国
- CAEN University Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Major epileptic patient
- Epilepsy diagnosed for at least 6 months before inclusion
Exclusion Criteria:
- Patient with mental disabilities (patient in an institution or with communication disorders, speech and verbal comprehension)
- Patients with disabling chronic condition other than epilepsy
- Patient consulting for the first time
- Patient whose diagnosis of epilepsy date of less than 6 months
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 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:EA group (Educational Actions)
Epileptic patients participating to the educational actions program
|
Individual educational session and 3 group educational sessions (5-6 patients per group) built around the epileptic disease, its treatment and daily life, will constitute the program of EA group.
|
无干预:Control group
Epileptic patients with standard follow-up
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 )
大体时间:Six months after enrollment
|
Six months after enrollment
|
合作者和调查者
调查人员
- 首席研究员:Sophie FONTAINE, Mme、University Hospital, Caen
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 15-206
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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