Epilepsy, Epileptic Encephalopathy, Refractory Epilepsy
Conditions
Keywords
Telemedicine, Epilepsy, Antiepileptic drugs monitoring
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.
Interventions
PROCEDURETelemedicine
Telemedicine versus usual care (face to face visit)
Sponsors
Azienda Usl di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* adult (age\>18 yrs) and pediatric (age\<18yrs) outpatients with established diagnosis of epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizures control through seizure diary | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADRs - Adverse Events Profile-AEP | 3 years | Comparing adverse drugs reactions among telemdicne group and usual care group (Adverse Events Profile-AEP) |
| Quality of life (QoL) | 3 years | Comparing quality of life among telemdicne group and usual care group (QoL In Epilepsy-QOLIE- 31,1.0,) |
| Pediatric quality of life (PedsQL) | 3 years | Comparing pediatric quality of life among telemdicne group and usual care group (Pediatric QoL Inventory-PedsQL) |
| Adherence to treatment | 3 years | Comparing Adherence to treatment (trough anti epileptic drug monitoring) among telemdicne group and usual care group |
| Mood-disorders - State-Trait Anxiety | 3 years | Comparing the occurence of mood-disorders (State-Trait Anxiety Inventory-STAI Y-1,2) |
| Mood-disorders - Child Behavior | 3 years | Comparing the occurence of mood-disorders (Child Behavior CheckList-CBCL for patients aged 6-18 yrs) |
| Mood-disorders - Beck Depression | 3 years | Comparing the occurence of mood-disorders (Beck Depression Inventory-BDI-II) |
Countries
Italy
Outcome results
None listed