TELEmedicine for EPIlepsy Care (TELE-EPIC): protocol of a randomised, open controlled non-inferiority clinical trial

Laura Licchetta, Marina Trivisano, Elisa Baldin, Susan Mohamed, Emanuel Raschi, Barbara Mostacci, Corrado Zenesini, Manuela Contin, Federico Vigevano, Francesca Bisulli, Paolo Tinuper, Luca Vignatelli, Laura Licchetta, Marina Trivisano, Elisa Baldin, Susan Mohamed, Emanuel Raschi, Barbara Mostacci, Corrado Zenesini, Manuela Contin, Federico Vigevano, Francesca Bisulli, Paolo Tinuper, Luca Vignatelli

Abstract

Introduction: 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).

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NCT04496310.

Keywords: COVID-19; epilepsy; telemedicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Provenience of extraregional patients referring to the Clinical Units over a 2-month period. Italian map showing the provenience of the extraregional outpatient visits referred to the Clinical Units involved in the study over the period 1 February 2018–30 March 2018. Adult Epilepsy Centre of IRCCS in Bologna (BO), Emilia-Romagna region (in red): visits are shown as red dots across several Italian regions. Paediatric Epilepsy Centre of Bambino Gesù Hospital, IRCCS in Rome (RM), Lazio region (in blue): visits are shown as blue dots across several regions.
Figure 2
Figure 2
Flow chart of the randomised controlled trial (TELE-EPIC_RCT). ADRs, adverse drug reactions; ASMs, anti-seizure medications; TM, telemedicine.

References

    1. Fiest KM, Sauro KM, Wiebe S, et al. . Prevalence and incidence of epilepsy: a systematic review and meta-analysis of international studies. Neurology 2017;88:296–303. 10.1212/WNL.0000000000003509
    1. Fiest KM, Birbeck GL, Jacoby A, et al. . Stigma in epilepsy. Curr Neurol Neurosci Rep 2014;14:444. 10.1007/s11910-014-0444-x
    1. Tellez-Zenteno JF, Patten SB, Jetté N, et al. . Psychiatric comorbidity in epilepsy: a population-based analysis. Epilepsia 2007;48:070728063136006 10.1111/j.1528-1167.2007.01222.x
    1. Jacoby A, Snape D, Baker GA. Determinants of quality of life in people with epilepsy. Neurol Clin 2009;27:843–63. 10.1016/j.ncl.2009.06.003
    1. Spindler UP, Hotopp LC, Bach VA, et al. . Seizure disorders and developmental disorders: impact on life of affected families—a structured interview. Eur J Pediatr 2017;176:1121–9. 10.1007/s00431-017-2958-0
    1. Begley CE, Beghi E. The economic cost of epilepsy: a review of the literature. Epilepsia 2002;43:3–9. 10.1046/j.1528-1157.43.s.4.2.x
    1. Murray CJL, Vos T, Lozano R, et al. . Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the global burden of disease study 2010. The Lancet 2012;380:2197–223. 10.1016/S0140-6736(12)61689-4
    1. Moshé SL, Perucca E, Ryvlin P, et al. . Epilepsy: new advances. Lancet 2015;385:884–98. 10.1016/S0140-6736(14)60456-6
    1. Perucca P, Gilliam FG. Adverse effects of antiepileptic drugs. Lancet Neurol 2012;11:792–802. 10.1016/S1474-4422(12)70153-9
    1. Kwan P, Sander JW. The natural history of epilepsy: an epidemiological view. J Neurol Neurosurg Psychiatry 2004;75:1376–81. 10.1136/jnnp.2004.045690
    1. Witt J-A, Elger CE, Helmstaedter C. Adverse cognitive effects of antiepileptic pharmacotherapy: each additional drug matters. Eur Neuropsychopharmacol 2015;25:1954–9. 10.1016/j.euroneuro.2015.07.027
    1. Linder C, Hansson A, Sadek S, et al. . Carbamazepine, lamotrigine, levetiracetam and valproic acid in dried blood spots with liquid chromatography tandem mass spectrometry; method development and validation. J Chromatogr B Analyt Technol Biomed Life Sci 2018;1072:116–22. 10.1016/j.jchromb.2017.11.005
    1. Protti M, Mandrioli R, Mercolini L. Tutorial: volumetric absorptive microsampling (VAMS). Anal Chim Acta 2019;1046:32–47. 10.1016/j.aca.2018.09.004
    1. WHO . Global observatory for ehealth, 2010. Available:
    1. Ghosh A, Gupta R, Misra A. Telemedicine for diabetes care in India during COVID19 pandemic and national lockdown period: guidelines for physicians. Diabetes Metab Syndr 2020;14:273–6. 10.1016/j.dsx.2020.04.001
    1. Charrier N, Zarca K, Durand-Zaleski I, et al. . Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res 2016;16. 10.1186/s12913-016-1281-1. [Epub ahead of print: Published 2016 Feb 8].
    1. Flodgren G, Rachas A, Farmer AJ, et al. . Interactive telemedicine: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2015;2016:CD002098. 10.1002/14651858.CD002098.pub2
    1. Bahrani K, Singh MB, Bhatia R, et al. . Telephonic review for outpatients with epilepsy-a prospective randomized, parallel group study. Seizure 2017;53:55–61. 10.1016/j.seizure.2017.11.003
    1. Rasmusson KA, Hartshorn JC. A comparison of epilepsy patients in a traditional ambulatory clinic and a telemedicine clinic. Epilepsia 2005;46:767–70. 10.1111/j.1528-1167.2005.44804.x
    1. Ahmed SN, Mann C, Sinclair DB, et al. . Feasibility of epilepsy follow-up care through telemedicine: a pilot study on the patient’s perspective. Epilepsia 2008;49:573–85. 10.1111/j.1528-1167.2007.01464.x
    1. Willems LM, Balcik Y, Noda AH, et al. . SARS-CoV-2-related rapid reorganization of an epilepsy outpatient clinic from personal appointments to telemedicine services: a German single-center experience. Epilepsy Behav 2020;112:107483. 10.1016/j.yebeh.2020.107483
    1. Semprino M, Fasulo L, Fortini S, et al. . Telemedicine, drug-resistant epilepsy, and ketogenic dietary therapies: a patient survey of a pediatric remote-care program during the COVID-19 pandemic. Epilepsy Behav 2020;112:107493. 10.1016/j.yebeh.2020.107493
    1. Santoro A, Genov G, Spooner A, et al. . Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf 2017;40:855–69. 10.1007/s40264-017-0572-8
    1. DʼUrso A, Rudge J, Patsalos PN, et al. . Volumetric absorptive microsampling: a new sampling tool for therapeutic drug monitoring of antiepileptic drugs. Ther Drug Monit 2019;41:681–92. 10.1097/FTD.0000000000000652
    1. Ingravallo F, Vignatelli L, Pagotto U, et al. . Protocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: telemedicine for narcolepsy (TENAR). BMC Neurol 2020;20:176. 10.1186/s12883-020-01762-9
    1. Scheffer IE, Berkovic S, Capovilla G, et al. . ILAE classification of the epilepsies: position paper of the ILAEcommission for classification and terminology. Epilepsia 2017;58:512–21. 10.1111/epi.13709
    1. Kwan P, Arzimanoglou A, Berg AT, et al. . Definition of drug resistant epilepsy: consensus proposal by the AD hoc task force of the ILAE commission on therapeutic strategies. Epilepsia 2010;51:1069–77. 10.1111/j.1528-1167.2009.02397.x
    1. EMEA/CHMP/EWP/192217/2009, Committee for Medicinal Products for Human Use (CHMP) . EMA guideline on bioanalytical method validation, 2011.
    1. Gunasekeran DV, Tseng RMWW, Tham Y-C, et al. . Applications of digital health for public health responses to COVID-19: a systematic scoping review of artificial intelligence, telehealth and related technologies. NPJ Digit Med 2021;4:40. 10.1038/s41746-021-00412-9
    1. Kuchenbuch M, D'Onofrio G, Wirrell E, et al. . An accelerated shift in the use of remote systems in epilepsy due to the COVID-19 pandemic. Epilepsy Behav 2020;112:107376. 10.1016/j.yebeh.2020.107376

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