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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
600
Telemedicine versus usual care (face to face visit)
Azienda USL di Bologna
Bologna, Italy
NOT_YET_RECRUITINGAzienda USL di Bologna
Bologna, Italy
RECRUITINGSeizures 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.
Time frame: 3 years
Adherence to treatment
Comparing Adherence to treatment (trough anti epileptic drug monitoring) among telemdicne group and usual care group
Time frame: 3 years
ADRs - Adverse Events Profile-AEP
Comparing adverse drugs reactions among telemdicne group and usual care group (Adverse Events Profile-AEP)
Time frame: 3 years
Quality of life (QoL)
Comparing quality of life among telemdicne group and usual care group (QoL In Epilepsy-QOLIE- 31,1.0,)
Time frame: 3 years
Pediatric quality of life (PedsQL)
Comparing pediatric quality of life among telemdicne group and usual care group (Pediatric QoL Inventory-PedsQL)
Time frame: 3 years
Mood-disorders - Beck Depression
Comparing the occurence of mood-disorders (Beck Depression Inventory-BDI-II)
Time frame: 3 years
Mood-disorders - State-Trait Anxiety
Comparing the occurence of mood-disorders (State-Trait Anxiety Inventory-STAI Y-1,2)
Time frame: 3 years
Mood-disorders - Child Behavior
Comparing the occurence of mood-disorders (Child Behavior CheckList-CBCL for patients aged 6-18 yrs)
Time frame: 3 years
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