Tele-epic (Telemedicine for Epilepsy Care)

Epilepsy Clinical Trial

— Tele-epic  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496310
• Other study ID #: GR-2018-12365475
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: July 8, 2023

Study information

• Verified date: February 2022
• Source: Azienda Usl di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 8, 2023
• Est. primary completion date: July 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Brain Diseases
• Drug Resistant Epilepsy
• Epilepsy
• Epileptic Encephalopathy
• Refractory Epilepsy

Intervention

Procedure:
• Telemedicine
Telemedicine versus usual care (face to face visit)

Locations

Country	Name	City	State
Italy	Azienda USL di Bologna	Bologna
Italy	Azienda USL di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

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