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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04496310
Other study ID # GR-2018-12365475
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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