Tele-epic (Telemedicine for Epilepsy Care) (Tele-epic)

February 15, 2022 updated by: Azienda Usl di Bologna

Telemedicine With Mobile Internet Devices for Innovative Care of Patients With Epilepsy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Recruiting
        • Azienda USL di Bologna
        • Contact:
      • Bologna, Italy
        • Not yet recruiting
        • Azienda USL di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult (age>18 yrs) and pediatric (age<18yrs) outpatients with established diagnosis of epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Telemedicine

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.
Procedure: Telemedicine
Telemedicine versus usual care (face to face visit)
NO_INTERVENTION: Usual care

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizures control through seizure diary
Time Frame: 3 years

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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: 3 years
Comparing Adherence to treatment (trough anti epileptic drug monitoring) among telemdicne group and usual care group
3 years
ADRs - Adverse Events Profile-AEP
Time Frame: 3 years
Comparing adverse drugs reactions among telemdicne group and usual care group (Adverse Events Profile-AEP)
3 years
Quality of life (QoL)
Time Frame: 3 years
Comparing quality of life among telemdicne group and usual care group (QoL In Epilepsy-QOLIE- 31,1.0,)
3 years
Pediatric quality of life (PedsQL)
Time Frame: 3 years
Comparing pediatric quality of life among telemdicne group and usual care group (Pediatric QoL Inventory-PedsQL)
3 years
Mood-disorders - Beck Depression
Time Frame: 3 years
Comparing the occurence of mood-disorders (Beck Depression Inventory-BDI-II)
3 years
Mood-disorders - State-Trait Anxiety
Time Frame: 3 years
Comparing the occurence of mood-disorders (State-Trait Anxiety Inventory-STAI Y-1,2)
3 years
Mood-disorders - Child Behavior
Time Frame: 3 years
Comparing the occurence of mood-disorders (Child Behavior CheckList-CBCL for patients aged 6-18 yrs)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2020

Primary Completion (ANTICIPATED)

July 8, 2023

Study Completion (ANTICIPATED)

July 8, 2023

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (ACTUAL)

August 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2018-12365475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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