Tele-epic (Telemedicine for Epilepsy Care)

Not Applicable

• Conditions: Epileptic Encephalopathy; Epilepsy; Refractory Epilepsy
• Interventions: Procedure: Telemedicine

• Registration Number: NCT04496310
• Lead Sponsor: Azienda Usl di Bologna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-06
• Study Start: 2020-07-09
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16
• Primary Completion: 2023-07-08
• Study Completion: 2023-07-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine	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.

Primary Outcome Measures

Name	Time	Method
Seizures control through seizure diary	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda USL di Bologna; 🇮🇹 Bologna, Italy