Syddansk Universitet Effectiveness of a comprehensive interactive eHealth intervention on patient reported and clinical outcomes in patients with an implantable cardioverter defibrillator ACQUIRE ICD trial study protocol of a national Danish randomised controlled trial
Background: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in hospital visits. Less patient nurse and patient physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE ICD care innovation, a comprehensive and interactive eHealth intervention, on patient reported and clinical outcomes. Methods: The ACQUIRE ICD study is a multicenter, prospective, two arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first time ICD or ICD with cardiac synchronisation therapy (CRT D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost effectiveness of the ACQUIRE ICD care innovation, as add on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost effectiveness. (Continued on next page) Correspondence: sspedersen@health.sdu.dk Department of Psychology, University of Southern Denmark, Campusvej 55, DK 5230 Odense M, Denmark Department of Cardiology, Odense University Hospital, Odense, Denmark Full list of author information is available at the end of the article (c) The Author(s) 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http:/creativecommons.org/licenses/by/4.0/ which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http:/creativecommons.org/publicdomain/zero/1.0/ applies to the data made available in this article, unless otherwise stated. Pedersen et al. BMC Cardiovascular Disorders (2018) 18:136 https:/doi.org/10.1186/s12872 018 0872 7