Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

• Conditions: Seizures; Epilepsy; Quality of Life; Patient Compliance; Children, Only

• Registration Number: NCT03753035
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-26
• Study Start: 2018-11-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16
• Primary Completion: 2019-04-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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)

Trial Locations

Locations (1)

GIRARD; 🇫🇷 Nancy, Lorraine, France