<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/NCT04496310</url>
  </required_header>
  <id_info>
    <org_study_id>GR-2018-12365475</org_study_id>
    <nct_id>NCT04496310</nct_id>
  </id_info>
  <brief_title>Tele-epic (Telemedicine for Epilepsy Care)</brief_title>
  <acronym>Tele-epic</acronym>
  <official_title>Telemedicine With Mobile Internet Devices for Innovative Care of Patients With Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Usl di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Usl di Bologna</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>
      Epilepsy is a chronic condition that requires consistent follow-up aimed at seizure control,&#xD;
      surveillance of comorbidities, monitoring of antiepileptic drugs (AED) levels and side&#xD;
      effects. Patients may encounter difficulties to be assessed adequately and the disease burden&#xD;
      is increased by the need for travelling across the country for medical consultations. Driving&#xD;
      restrictions are a further limit to access specialized Centers able to provide an integrated&#xD;
      approach focused on patient needs. Telemedicine (TM) offers an invaluable support to patient&#xD;
      follow-up, joining the sparse distribution of patients in the country with the prompt&#xD;
      availability of a team of experts. The project assesses, through a randomized controlled&#xD;
      trial, the non-inferiority of TM in monitoring seizure control compared to usual&#xD;
      (face-to-face) care. This approach, coupled with a new self home-sampling method for the&#xD;
      measurement of AED levels, will reduce health care costs and simplify patients management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Anticipated">July 8, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 8, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seizures control through seizure diary</measure>
    <time_frame>3 years</time_frame>
    <description>Non-inferiority in seizures control of follow-up procedures through video consultations with telemedicine devices versus in-office, usual care (UC).&#xD;
Outcomes: non-inferiority of mTM on the primary end-point (seizure control assessed through seizure diary) at 18 month follow- up.&#xD;
Assessment of &quot;seizure control&quot; at the end of 18 month-follow-up. Clinical worsening defined as at least 1: (i) fall of at least 2 positions of the following frequency categories: daily/multiple per day; multiple/week, weekly; multiple/month; monthly; multiple/year; annual; (ii) relapse after SF; (iii) new-onset/relapse of convulsive seizures, tonic/atonic seizures with fall, status epilepticus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to treatment</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing Adherence to treatment (trough anti epileptic drug monitoring) among telemdicne group and usual care group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADRs - Adverse Events Profile-AEP</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing adverse drugs reactions among telemdicne group and usual care group (Adverse Events Profile-AEP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing quality of life among telemdicne group and usual care group (QoL In Epilepsy-QOLIE- 31,1.0,)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric quality of life (PedsQL)</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing pediatric quality of life among telemdicne group and usual care group (Pediatric QoL Inventory-PedsQL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood-disorders - Beck Depression</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing the occurence of mood-disorders (Beck Depression Inventory-BDI-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood-disorders - State-Trait Anxiety</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing the occurence of mood-disorders (State-Trait Anxiety Inventory-STAI Y-1,2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood-disorders - Child Behavior</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing the occurence of mood-disorders (Child Behavior CheckList-CBCL for patients aged 6-18 yrs)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Epilepsy</condition>
  <condition>Epileptic Encephalopathy</condition>
  <condition>Refractory Epilepsy</condition>
  <arm_group>
    <arm_group_label>Telemedicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baseline: in office clinical assessment of all patients (collection of seizure diary).&#xD;
Followup: scheduled 6-month consultations through a telemedicine device providing remote outcome assessment, counselling and follow-up. If required, on call video consultations available by contacting a provider through telemedicine, 3-hr/week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Baseline: in office clinical assessment of all patients (collection of seizure diary).&#xD;
Followup: scheduled 6-month in-office consultations with outcome assessment, counselling and follow-up. On-call consultations are possible if needed by the patient, by contacting a clinician through an in-office phone call, 3-hr/week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Telemedicine</intervention_name>
    <description>Telemedicine versus usual care (face to face visit)</description>
    <arm_group_label>Telemedicine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult (age&gt;18 yrs) and pediatric (age&lt;18yrs) outpatients with established diagnosis of&#xD;
             epilepsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda USL di Bologna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>laura licchetta, MD, PhD</last_name>
      <phone>+39 0514966991</phone>
      <email>laura.licchetta2@unibo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda USL di Bologna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>laura licchetta, md, phd</last_name>
      <phone>+390514966991</phone>
      <email>laura.licchetta2@unibo.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Epilepsy</keyword>
  <keyword>Antiepileptic drugs monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04496310
org study id: GR-2018-12365475
nct id: NCT04496310
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epilepsy is a chronic condition that requires consistent follow-up aimed at seizure control,
      surveillance of comorbidities, monitoring of antiepileptic drugs (AED) levels and side
      effects. Patients may encounter difficulties to be assessed adequately and the disease burden
      is increased by the need for travelling across the country for medical consultations. Driving
      restrictions are a further limit to access specialized Centers able to provide an integrated
      approach focused on patient needs. Telemedicine (TM) offers an invaluable support to patient
      follow-up, joining the sparse distribution of patients in the country with the prompt
      availability of a team of experts. The project assesses, through a randomized controlled
      trial, the non-inferiority of TM in monitoring seizure control compared to usual
      (face-to-face) care. This approach, coupled with a new self home-sampling method for the
      measurement of AED levels, will reduce health care costs and simplify patients management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Seizures control through seizure diary
time frame: 3 years
description: Non-inferiority in seizures control of follow-up procedures through video consultations with telemedicine devices versus in-office, usual care (UC).
Outcomes: non-inferiority of mTM on the primary end-point (seizure control assessed through seizure diary) at 18 month follow- up.
Assessment of "seizure control" at the end of 18 month-follow-up. Clinical worsening defined as at least 1: (i) fall of at least 2 positions of the following frequency categories: daily/multiple per day; multiple/week, weekly; multiple/month; monthly; multiple/year; annual; (ii) relapse after SF; (iii) new-onset/relapse of convulsive seizures, tonic/atonic seizures with fall, status epilepticus.
measure: Adherence to treatment
time frame: 3 years
description: Comparing Adherence to treatment (trough anti epileptic drug monitoring) among telemdicne group and usual care group
measure: ADRs - Adverse Events Profile-AEP
time frame: 3 years
description: Comparing adverse drugs reactions among telemdicne group and usual care group (Adverse Events Profile-AEP)
measure: Quality of life (QoL)
time frame: 3 years
description: Comparing quality of life among telemdicne group and usual care group (QoL In Epilepsy-QOLIE- 31,1.0,)
measure: Pediatric quality of life (PedsQL)
time frame: 3 years
description: Comparing pediatric quality of life among telemdicne group and usual care group (Pediatric QoL Inventory-PedsQL)
measure: Mood-disorders - Beck Depression
time frame: 3 years
description: Comparing the occurence of mood-disorders (Beck Depression Inventory-BDI-II)
measure: Mood-disorders - State-Trait Anxiety
time frame: 3 years
description: Comparing the occurence of mood-disorders (State-Trait Anxiety Inventory-STAI Y-1,2)
measure: Mood-disorders - Child Behavior
time frame: 3 years
description: Comparing the occurence of mood-disorders (Child Behavior CheckList-CBCL for patients aged 6-18 yrs)
arm group label: Telemedicine
arm group type: Experimental
description: Baseline: in office clinical assessment of all patients (collection of seizure diary).
Followup: scheduled 6-month consultations through a telemedicine device providing remote outcome assessment, counselling and follow-up. If required, on call video consultations available by contacting a provider through telemedicine, 3-hr/week.
arm group label: Usual care
arm group type: No Intervention
description: Baseline: in office clinical assessment of all patients (collection of seizure diary).
Followup: scheduled 6-month in-office consultations with outcome assessment, counselling and follow-up. On-call consultations are possible if needed by the patient, by contacting a clinician through an in-office phone call, 3-hr/week.
intervention type: Procedure
intervention name: Telemedicine
description: Telemedicine versus usual care (face to face visit)
arm group label: Telemedicine
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Brain Diseases
mesh term: Drug Resistant Epilepsy
sharing ipd: No