Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children (ObEPI)

April 12, 2019 updated by: Central Hospital, Nancy, France
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all epileptic children at Nancy Children Hospital

Description

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • epileptic encephalopathy
  • Multiply handicapped child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
epileptic children
Completion of questionnaire, during medical consultation, on compliance and quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance score of the modified Modified Morisky Medication Adherence Scales 8
Time Frame: 6 months
distribution of responses to new items of the modified MMAS8 scale, internal structure)
6 months
quality of life of epileptic children
Time Frame: 6 months
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
6 months
syndromes
Time Frame: 6 months
MMAS8 compliance score according to syndromes and equilibrium of epilepsy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2018

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

November 22, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ObEPI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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