EpilepsyObEPINCT03753035
Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children
An observational study of Epilepsy and Children, Only, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Epilepsy, Children, Only, Quality of Life
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2018to 30 Sep 2019
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- Child, Adult
Study population: all epileptic children at Nancy Children Hospital
Who may be able to join
- • Child aged 5 to 17
- Child who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data
- Holder (s) of the parental authority present (s) having received the complete information on the organization of the research and not being opposed to the participation and the exploitation of the data of his child
- Epileptic child
- Follow-up at the neuro pediatric department of CHRU Nancy
Who cannot join
- epileptic encephalopathy
- Multiply handicapped child
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GIRARD
Nancy, Lorraine, 54520
Barbara GIRARD, +33659302057, barbara.girard54@gmail.com
About this study
There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. To obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). Propose an evaluation of the quality of life of their children by a suitable self-questionnaire.
- Conditions
- Epilepsy, Children, Only, Quality of Life, Seizures, Patient Compliance
- Keywords
- epilepsy, children, seizures, patient compliance, quality of life
- Medical subject headings
- Epilepsy, Seizures, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| epileptic children | Completion of questionnaire, during medical consultation, on compliance and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean compliance
Mean compliance score measured by the validated Modified Morisky Medication Adherence Scales 8 for epileptic patients 11 subscale with a 5-point Likert scale. According to the scoring system for the MMAS, 8=high adherence, 6 to <8=medium adherence, and <6=low adherence. Patients who had a low or a moderate rate of adherence were considered nonadherent5.
Measured: 6 months
Secondary outcomes (3)
Compliance score of the modified Modified Morisky Medication Adherence Scales 8
distribution of responses to new items of the modified MMAS8 scale, internal structure)
Measured: 6 months
quality of life of epileptic children
Quality of life score measured by the IImpact of Pediatric Epilepsy Scale An 11-item scale was created for children and/or parents' use (according to age) to evaluate the influence of epilepsy on the major aspects of their family and child's life 5 items scale with a 5 point Likert scale
Measured: 6 months
syndromes
MMAS8 compliance score according to syndromes and equilibrium of epilepsy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start29 Nov 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753035
- Sponsor's protocol ID
- ObEPI
- Acronym
- ObEPI
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children
- ClinicalTrials.gov ID
- NCT03753035
- Acronym / sponsor ID
- ObEPI / ObEPI
- Conditions
- Epilepsy, Children, Only, Quality of Life, Seizures, Patient Compliance
- Keywords
- epilepsy, children, seizures, patient compliance, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 26 Nov 2018 (actual)
- 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.
There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. To obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). Propose an evaluation of the quality of life of their children by a suitable self-questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epileptic children | – | –Completion of questionnaire, during medical consultation, on compliance and quality of life |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- all epileptic children at Nancy Children Hospital
Key inclusion criteria (5 listed)
- • Child aged 5 to 17
Key exclusion criteria (2 listed)
- epileptic encephalopathy
- Multiply handicapped child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean compliance
Time frame: 6 months
Mean compliance score measured by the validated Modified Morisky Medication Adherence Scales 8 for epileptic patients 11 subscale with a 5-point Likert scale. According to the scoring system for the MMAS, 8=high adherence, 6 to <8=medium adherence, and <6=low adherence. Patients who had a low or a moderate rate of adherence were considered nonadherent5.
3 secondary outcomes
Compliance score of the modified Modified Morisky Medication Adherence Scales 8
Time frame: 6 months
quality of life of epileptic children
Time frame: 6 months
syndromes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Children, Only, run by Central Hospital, Nancy, France 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean compliance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2019.