NCT03753035

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

November 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

November 22, 2018

Last Update Submit

April 12, 2019

Conditions

Keywords

epilepsychildrenseizurespatient compliancequality of life

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

Age5 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

EpilepsySeizuresPatient Compliance

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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

Locations