跳至主要内容
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2016年10月1日
适应症Epilepsy

概览

阶段
不适用
干预措施
Educational Actions
疾病 / 适应症
Epilepsy
发起方
University Hospital, Caen
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 )
状态
已完成
最后更新
2个月前

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: 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.

注册库
clinicaltrials.gov
开始日期
2016年10月1日
结束日期
2019年1月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

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)

Epileptic patients participating to the educational actions program

干预措施: Educational Actions

Control group

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

研究点 (1)

Loading locations...

相似试验