Telemedicine With Mobile Internet Devices for Innovative Care of Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Seizures control through seizure diary
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (age>18 yrs) and pediatric (age<18yrs) outpatients with established diagnosis of epilepsy.
排除标准
- 未提供
结局指标
主要结局
Seizures control through seizure diary
时间窗: 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.
次要结局
- Quality of life (QoL)(3 years)
- Pediatric quality of life (PedsQL)(3 years)
- Mood-disorders - Beck Depression(3 years)
- Mood-disorders - Child Behavior(3 years)
- Adherence to treatment(3 years)
- ADRs - Adverse Events Profile-AEP(3 years)
- Mood-disorders - State-Trait Anxiety(3 years)