Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): a randomized controlled trial.

Autor:	Skov O; Department of Psychology, University of Southern Denmark, Campusvej 55, DK-5230 Odense, Denmark., Johansen JB; Department of Cardiology, Odense University Hospital, Odense, Denmark., Nielsen JC; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Larroudé CE; Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark., Riahi S; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark., Melchior TM; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark., Vinther M; Department of Cardiology B, Rigshospitalet, Copenhagen, Denmark., Skovbakke SJ; Department of Psychology, University of Southern Denmark, Campusvej 55, DK-5230 Odense, Denmark., Rottmann N; Department of Psychology, University of Southern Denmark, Campusvej 55, DK-5230 Odense, Denmark., Wiil UK; SDU Health Informatics and Technology, The Maersk Mc-Kinney Moller Institute, University of Southern Denmark, Odense, Denmark., Brandt CJ; Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark., Smolderen KG; Department of Internal Medicine, Vascular Medicine Outcomes Program, Yale School of Medicine, New Haven, CT, USA.; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA., Spertus JA; Kansas City's Healthcare Institute for Innovations in Quality and Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City, MO, USA., Pedersen SS; Department of Psychology, University of Southern Denmark, Campusvej 55, DK-5230 Odense, Denmark.; Department of Cardiology, Odense University Hospital, Odense, Denmark.
Jazyk:	angličtina
Zdroj:	Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology [Europace] 2023 Dec 06; Vol. 25 (12).
DOI:	10.1093/europace/euad253
Abstrakt:	Aims: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. Methods and Results: This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]. Conclusion: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients. Competing Interests: Conflict of interest: J.C.N. received institutional grants from the Novo Nordisk Foundation and the Danish Heart Foundation. J.B.J. is a consultant for Medtronic. M.V. serves on conduction system pacing advisory boards for Medtronic and Abbott. K.G.S. reports unrestricted research grants from Philips, Abbott, Merck, and Johnson & Johnson, and she is a consultant for Optum Labs and Abbott, Happify, and Haemonetics. K.G.S. is supported by NIH grants 1R21AT012430-01 (NCCIH) and 1R01HL163640-01A1 (NHLBI). J.A.S. has no conflicts of interest for the study but discloses providing consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare. He holds research grants from Bristol Meyers Squibb, Abbott Vascular, and Janssen. He owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. All remaining authors have declared no conflicts of interest. (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
Databáze:	MEDLINE
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