EpilepsyEQOLENCT02832349
Impact of Educational Actions on the Quality Of Life of Epileptic Patients
A study testing Educational Actions in people with Epilepsy, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Educational Actions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2016to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major epileptic patient
- Epilepsy diagnosed for at least 6 months before inclusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Educational Actions
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ActionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EA group (Educational Actions) | Experimental | Epileptic patients participating to the educational actions program Receives: Other: Educational Actions |
| Control group | No intervention | Epileptic patients with standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 )
Measured: Six months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start1 Oct 2016
- Primary completion1 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie FONTAINE, Mme, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832349
- Sponsor's protocol ID
- 15-206
- Acronym
- EQOLE
- Status last verified
- Jul 2017
- First submitted
- 5 Jul 2016
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37027966
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Educational Actions on the Quality Of Life of Epileptic Patients
- ClinicalTrials.gov ID
- NCT02832349
- Acronym / sponsor ID
- EQOLE / 15-206
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA group (Educational Actions) | Experimental | Other: Educational ActionsEpileptic patients participating to the educational actions program |
| Control group | No intervention | –Epileptic patients with standard follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major epileptic patient
- Epilepsy diagnosed for at least 6 months before inclusion
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational ActionsIndividual 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. | Other | EA group (Educational Actions) |
Primary outcome
Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 )
Time frame: Six months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publication: PubMed 37027966Fontaine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie FONTAINE, Mme principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Actions in people with Epilepsy, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score difference at the scale Quality Of Life in Epilepsy -31 (QOLIE-31 ) (time frame: Six months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.