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EpilepsyTele-epicNCT04496310

Tele-epic (Telemedicine for Epilepsy Care)

A study testing Telemedicine in people with Epilepsy and Epileptic Encephalopathy, run by Azienda Usl di Bologna at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Telemedicine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
2 sitesItaly
Study dates
9 Jul 2020to 8 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites, 2 recruiting

  • Azienda USL di Bologna

    Bologna

    laura licchetta, MD, PhD, +39 0514966991, laura.licchetta2@unibo.it

    Not yet recruiting

  • Azienda USL di Bologna

    Bologna

    laura licchetta, md, phd, +390514966991, laura.licchetta2@unibo.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Being tested
Telemedicine
Keywords
Telemedicine, Epilepsy, Antiepileptic drugs monitoring
Medical subject headings
Epilepsy, Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemedicineProcedure or surgery

    Telemedicine versus usual care (face to face visit)

Study groups in NCT04496310
Study groupRoleWhat they receive
TelemedicineExperimentalBaseline: 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.
Receives: Procedure: Telemedicine
Usual careNo interventionBaseline: 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (7)

  1. Adherence to treatment

    Comparing Adherence to treatment (trough anti epileptic drug monitoring) among telemdicne group and usual care group

    Measured: 3 years

  2. ADRs - Adverse Events Profile-AEP

    Comparing adverse drugs reactions among telemdicne group and usual care group (Adverse Events Profile-AEP)

    Measured: 3 years

  3. Quality of life (QoL)

    Comparing quality of life among telemdicne group and usual care group (QoL In Epilepsy-QOLIE- 31,1.0,)

    Measured: 3 years

  4. Pediatric quality of life (PedsQL)

    Comparing pediatric quality of life among telemdicne group and usual care group (Pediatric QoL Inventory-PedsQL)

    Measured: 3 years

  5. Mood-disorders - Beck Depression

    Comparing the occurence of mood-disorders (Beck Depression Inventory-BDI-II)

    Measured: 3 years

  6. Mood-disorders - State-Trait Anxiety

    Comparing the occurence of mood-disorders (State-Trait Anxiety Inventory-STAI Y-1,2)

    Measured: 3 years

  7. Mood-disorders - Child Behavior

    Comparing the occurence of mood-disorders (Child Behavior CheckList-CBCL for patients aged 6-18 yrs)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2020
  2. Study start9 Jul 2020
  3. Primary completion8 Jul 2023 (estimated)
  4. Study completion8 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04496310
Sponsor's protocol ID
GR-2018-12365475
Acronym
Tele-epic
Status last verified
Feb 2022
First submitted
6 Jul 2020
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34862297

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine in people with Epilepsy and Epileptic Encephalopathy, run by Azienda Usl di Bologna at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seizures control through seizure diary (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04496310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022; AzTrials last refreshed its copy on 1 Nov 2026.

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