Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children
ObEPI
1 other identifier
observational
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2018
CompletedFirst Posted
Study publicly available on registry
November 26, 2018
CompletedStudy Start
First participant enrolled
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedApril 16, 2019
April 1, 2019
5 months
November 22, 2018
April 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Compliance score of the modified Modified Morisky Medication Adherence Scales 8
6 months
quality of life of epileptic children
6 months
syndromes
6 months
Study Arms (1)
epileptic children
Completion of questionnaire, during medical consultation, on compliance and quality of life
Eligibility Criteria
all epileptic children at Nancy Children Hospital
You may qualify if:
- 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
You may not qualify if:
- epileptic encephalopathy
- Multiply handicapped child
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GIRARD
Nancy, Lorraine, 54520, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2018
First Posted
November 26, 2018
Study Start
November 29, 2018
Primary Completion
April 30, 2019
Study Completion
September 30, 2019
Last Updated
April 16, 2019
Record last verified: 2019-04