ObEPI: Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03753035

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Children, Only Quality of Life Seizures Patient Compliance

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

Actual Study Start Date :

Nov 29, 2018

Anticipated Primary Completion Date :

Apr 30, 2019

Anticipated Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
epileptic children Completion of questionnaire, during medical consultation, on compliance and quality of life

Outcome Measures

Primary Outcome Measures

Mean compliance [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

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