IRCCS, Instituto delle Scienze Neurologiche di Bologna, Full Member of European Reference Network EpiCARE, Bologna, Italy
Department of Neuroscience, Rare and Complex Epilepsies Unit, Bambino Gesù Children's Hospital, IRCCS, Full Member of European Reference Network EpiCARE, Rome, Italy.
BMJ Open. 2021 Dec 3;11(12):e053980. doi: 10.1136/bmjopen-2021-053980.
Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS).
TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device.
The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project's webpage on ClinicalTrials.gov. The project's results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.
NCT04496310.
癫痫是一种需要持续随访以控制癫痫发作并监测抗癫痫药物（ASM）水平和副作用的慢性病。远程医疗（TM）为患者随访提供了宝贵的支持，确保全国各地的癫痫患者（PWE）都能及时获得专家团队的支持。尽管许多医疗机构都认可 TM 的使用，但缺乏关于 TM 在癫痫中的有效性、安全性和成本的可靠数据。TELEmedicine for EPIlepsy Care（TELE-EPIC）将评估通过 TM 进行视频咨询（VC）与常规护理（UC）相比，对 PWE 监测的有效性（TELE-EPIC_RCT）。此外，TELE-EPIC 将应用创新的容积吸收微采样（VAMS）设备通过指尖采血进行 ASM 定量，作为静脉采血采样的替代方法（TELE-EPIC_VAMS）。
TELE-EPIC_RCT 是一项多中心、开放、实用的两臂随机对照试验，前瞻性纳入分别连续就诊于博洛尼亚和罗马癫痫中心的成年和儿科门诊患者，诊断为癫痫。主要结局是在 18 个月随访后，VC 在控制癫痫发作方面不劣于 UC。次要结局包括治疗依从性、ASM 相关不良事件、生活质量、情绪障碍、患者和护理人员满意度、安全性和成本。TELE-EPIC_VAMS 是一种通过新型 VAMS 设备进行血液 ASM 定量的交叉验证研究，比较（1）VAMS 与血浆样本（参考标准方法）；（2）由护士采集与 VAMS 设备采集的自采血液。
该研究已获得当地伦理委员会（349-2019-SPER-AUSLBO）的批准。关于项目状态、相关事件和结果的完整信息将定期在项目的 ClinicalTrials.gov 网页上更新。项目的结果和 TM 在癫痫中的潜在影响的数据将在社交媒体上传播。将召开项目结束会议，以交流和传播项目，强调其主要成就和影响。
NCT04496310。
