ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Educational Actions on the Quality Of Life of Epileptic Patients (EQOLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02832349
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Educational Actions Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 ) [ Time Frame: Six months after enrollment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Sophie FONTAINE, Mme +33231063106 fontaine-s@chu-caen.fr
Contact: Laure GAUTIER, Mme +33231063106 gautier-l@chu-caen.fr

Locations
France
Caen University Hospital Recruiting
Caen, France
Contact: Fontaine Sophie       fontaine-s@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Sophie FONTAINE, Mme University Hospital, Caen

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02832349     History of Changes
Other Study ID Numbers: 15-206
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No