NCT02832349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 17, 2026

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 5, 2016

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Six months after enrollment

Study Arms (2)

EA group (Educational Actions)

EXPERIMENTAL

Epileptic patients participating to the educational actions program

Other: Educational Actions

Control group

NO INTERVENTION

Epileptic patients with standard follow-up

Interventions

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.

EA group (Educational Actions)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major epileptic patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

Location

Related Publications (1)

  • Fontaine S, Gautier L, Diependaele AS, Hamieh M, Morello R, Guillouet S, Bertran F. Impact of educational actions on the quality of life of patients with epilepsy: A randomised controlled trial. Epilepsy Res. 2023 May;192:107128. doi: 10.1016/j.eplepsyres.2023.107128. Epub 2023 Mar 24.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sophie FONTAINE, Mme

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 14, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

February 17, 2026

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations