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临床试验/NCT02832349
NCT02832349已完成不适用

Impact of Educational Actions on the Quality Of Life of Epileptic Patients

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 )

研究概览

简要总结

The Epilepsy Patient Education (EPE) is very important for the comprehension of the disease and its management. The EPE allows patients and caregivers to acquire together some autonomy and some skills that will help them live better with the disease.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).Investigators hope a difference in improving the quality of life score of 25% between the 2 groups.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Major epileptic patient
  • Epilepsy diagnosed for at least 6 months before inclusion

排除标准

  • 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

研究组 & 干预措施

EA group (Educational Actions)

Experimental

Epileptic patients participating to the educational actions program

干预措施: Educational Actions (Other)

Control group

No Intervention

Epileptic patients with standard follow-up

结局指标

主要结局

Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 )

时间窗: Six months after enrollment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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