NCT04496310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2023

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

July 6, 2020

Last Update Submit

February 15, 2022

Conditions

EpilepsyEpileptic EncephalopathyRefractory Epilepsy

Keywords

TelemedicineEpilepsyAntiepileptic drugs monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Adherence to treatment

    3 years

  • ADRs - Adverse Events Profile-AEP

    3 years

  • Quality of life (QoL)

    3 years

  • Pediatric quality of life (PedsQL)

    3 years

  • Mood-disorders - Beck Depression

    3 years

  • +2 more secondary outcomes

Study Arms (2)

Telemedicine

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

TelemedicinePROCEDURE

Telemedicine versus usual care (face to face visit)

Telemedicine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azienda USL di Bologna

Bologna, Italy

NOT YET RECRUITING

Azienda USL di Bologna

Bologna, Italy

RECRUITING

Related Publications (1)

  • Licchetta L, Trivisano M, Baldin E, Mohamed S, Raschi E, Mostacci B, Zenesini C, Contin M, Vigevano F, Bisulli F, Tinuper P, Vignatelli L. TELEmedicine for EPIlepsy Care (TELE-EPIC): protocol of a randomised, open controlled non-inferiority clinical trial. BMJ Open. 2021 Dec 3;11(12):e053980. doi: 10.1136/bmjopen-2021-053980.

    PMID: 34862297DERIVED

MeSH Terms

Conditions

EpilepsyDrug Resistant Epilepsy

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

August 3, 2020

Study Start

July 9, 2020

Primary Completion

July 8, 2023

Study Completion

July 8, 2023

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)