Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

Quality of Life Clinical Trial

— ObEPI  

Official title:

Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753035
• Other study ID #: ObEPI
• Status: Recruiting
• Start date: November 29, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: April 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 30, 2019
• Est. primary completion date: April 30, 2019
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Epilepsy
• Patient Compliance
• Quality of Life
• Seizures

Locations

Country	Name	City	State
France	GIRARD	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Compliance score of the modified Modified Morisky Medication Adherence Scales 8	distribution of responses to new items of the modified MMAS8 scale, internal structure)	6 months
Secondary	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	6 months
Secondary	syndromes	MMAS8 compliance score according to syndromes and equilibrium of epilepsy	6 months