Tele-epic (Telemedicine for Epilepsy Care)

NCT ID: NCT04496310

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-09

Study Completion Date

2023-07-08

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.

Detailed Description

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Conditions

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Epilepsy Epileptic Encephalopathy Refractory Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Telemedicine

Intervention Type PROCEDURE

Telemedicine versus usual care (face to face visit)

Usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemedicine

Telemedicine versus usual care (face to face visit)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda USL di Bologna

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Azienda USL di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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laura licchetta, MD, PhD

Role: primary

+39 0514966991

laura licchetta, md, phd

Role: primary

+390514966991

References

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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.

Reference Type DERIVED
PMID: 34862297 (View on PubMed)

Other Identifiers

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GR-2018-12365475

Identifier Type: -

Identifier Source: org_study_id

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