Impact of Educational Actions on the Quality Of Life of Epileptic Patients (EQOLE)
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|ClinicalTrials.gov Identifier: NCT02832349|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Other: Educational Actions||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Educational Actions on the Quality Of Life of Epileptic Patients|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: EA group (Educational Actions)
Epileptic patients participating to the educational actions program
Other: Educational Actions
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.
No Intervention: Control group
Epileptic patients with standard follow-up
- Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 ) [ Time Frame: Six months after enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832349
|Contact: Sophie FONTAINE, Mmefirstname.lastname@example.org|
|Contact: Laure GAUTIER, Mmeemail@example.com|
|Caen University Hospital||Recruiting|
|Contact: Fontaine Sophie firstname.lastname@example.org|
|Principal Investigator:||Sophie FONTAINE, Mme||University Hospital, Caen|