<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03753035</url>
  </required_header>
  <id_info>
    <org_study_id>ObEPI</org_study_id>
    <nct_id>NCT03753035</nct_id>
  </id_info>
  <brief_title>Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children</brief_title>
  <acronym>ObEPI</acronym>
  <official_title>Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is little epidemiological data in the literature on the therapeutic compliance of&#xD;
      epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of&#xD;
      this pathology. To obtain more epidemiological precision on the observance of epileptic&#xD;
      children and to propose, according to the factors involved, the improvement of practices&#xD;
      (therapeutic education ..). Propose an evaluation of the quality of life of their children by&#xD;
      a suitable self-questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean compliance</measure>
    <time_frame>6 months</time_frame>
    <description>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 &lt;8=medium adherence, and &lt;6=low adherence. Patients who had a low or a moderate rate of adherence were considered nonadherent5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance score of the modified Modified Morisky Medication Adherence Scales 8</measure>
    <time_frame>6 months</time_frame>
    <description>distribution of responses to new items of the modified MMAS8 scale, internal structure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life of epileptic children</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>syndromes</measure>
    <time_frame>6 months</time_frame>
    <description>MMAS8 compliance score according to syndromes and equilibrium of epilepsy</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Epilepsy</condition>
  <condition>Children, Only</condition>
  <condition>Quality of Life</condition>
  <condition>Seizures</condition>
  <condition>Patient Compliance</condition>
  <arm_group>
    <arm_group_label>epileptic children</arm_group_label>
    <description>Completion of questionnaire, during medical consultation, on compliance and quality of life</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        all epileptic children at Nancy Children Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Child aged 5 to 17&#xD;
&#xD;
               -  Child who has received complete information on the organization of the research&#xD;
                  and who has not objected to his participation and the exploitation of his data&#xD;
&#xD;
               -  Holder (s) of the parental authority present (s) having received the complete&#xD;
                  information on the organization of the research and not being opposed to the&#xD;
                  participation and the exploitation of the data of his child&#xD;
&#xD;
               -  Epileptic child&#xD;
&#xD;
               -  Follow-up at the neuro pediatric department of CHRU Nancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  epileptic encephalopathy&#xD;
&#xD;
          -  Multiply handicapped child&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>GIRARD</name>
      <address>
        <city>Nancy</city>
        <state>Lorraine</state>
        <zip>54520</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara GIRARD</last_name>
      <phone>+33659302057</phone>
      <email>barbara.girard54@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epilepsy</keyword>
  <keyword>children</keyword>
  <keyword>seizures</keyword>
  <keyword>patient compliance</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03753035
org study id: ObEPI
nct id: NCT03753035
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Mean compliance
time frame: 6 months
description: 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.
measure: Compliance score of the modified Modified Morisky Medication Adherence Scales 8
time frame: 6 months
description: distribution of responses to new items of the modified MMAS8 scale, internal structure)
measure: quality of life of epileptic children
time frame: 6 months
description: 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
measure: syndromes
time frame: 6 months
description: MMAS8 compliance score according to syndromes and equilibrium of epilepsy
arm group label: epileptic children
description: Completion of questionnaire, during medical consultation, on compliance and quality of life
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Seizures