Tele-epic (Telemedicine for Epilepsy Care)

Study Overview
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Brief Summary
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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.

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

Conditions
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Epilepsy, Epileptic Encephalopathy, Refractory Epilepsy

Intervention / Treatment
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* Procedure: Telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult (age>18 yrs) and pediatric (age<18yrs) outpatients with established diagnosis of epilepsy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>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<br>* Telemedicine versus usual care (face to face visit)<br>|
| No Intervention: Usual care<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Epilepsy, Antiepileptic drugs monitoring