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

Susanne S Pedersen, Søren J Skovbakke, Uffe K Wiil, Thomas Schmidt, Rene dePont Christensen, Carl J Brandt, Jan Sørensen, Michael Vinther, Charlotte E Larroudé, Thomas M Melchior, Sam Riahi, Kim G E Smolderen, John A Spertus, Jens B Johansen, Jens C Nielsen, Susanne S Pedersen, Søren J Skovbakke, Uffe K Wiil, Thomas Schmidt, Rene dePont Christensen, Carl J Brandt, Jan Sørensen, Michael Vinther, Charlotte E Larroudé, Thomas M Melchior, Sam Riahi, Kim G E Smolderen, John A Spertus, Jens B Johansen, Jens C Nielsen

Abstract

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.

Discussion: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients.

Trial registration: The trial has been registered on https://ichgcp.net/clinical-trials-registry/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

Keywords: Anxiety; Depression; Device acceptance; Heart disease; Implantable cardioverter defibrillator; Patient-centered tools; Quality of life; eHealth intervention.

Conflict of interest statement

Ethics approval and consent to participate

Every patient will receive written and oral information about the study and sign an informed consent form prior to enrollment. The study protocol was submitted to the Regional Committees on Health Research Ethics for Southern Denmark, who indicated that according to Danish law about ethics related to health research (§ 14, 1), ethical committee approval is not required (VEK #S-20160063, June 13, 2016).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests, except CJB who owns shares in Liva Healhcare AS, the company that has developed parts of the technical platform, LIVA, used in the study.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Design and flowchart of patient inclusion and follow-up

References

    1. Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC) Eur Heart J. 2015;36:2793–2867. doi: 10.1093/eurheartj/ehv316.
    1. Borne RT, Katz D, Betz J, Peterson PN, Masoudi FA. Implantable cardioverter-defibrillators for secondary prevention of sudden cardiac death: a review. J Am Heart Assoc. 2017;6(3):e005515. doi: 10.1161/JAHA.117.005515.
    1. Siddiqui WJ, Aggarwal S, Rafique M, Singh S, Kutalek S, Eisen HJ. Prophylactic use of the implantable cardioverter-defibrillator and its effect on the long-term survival, cardiovascular and sudden cardiac death in nonischemic cardiomyopathy patients-a systematic review and meta-analysis. Heart Fail Rev. 2018;23(2):181–190. doi: 10.1007/s10741-018-9671-6.
    1. Raatikainen MJP, Arnar DO, Merkely B, et al. A decade of information on the use of cardiac implantable electronic devices and interventional electrophysiological procedures in the European Society of Cardiology Countries: 2017 report from the European heart rhythm association. Europace. 2017;19:ii1–ii90. doi: 10.1093/europace/eux258.
    1. Pedersen SS, Hoogwegt MT, Jordaens L, Theuns DAMJ. Pre implantation psychological functioning preserved in majority of implantable cardioverter defibrillator patients 12months post implantation. Int J Cardiol. 2013;166:215–220. doi: 10.1016/j.ijcard.2011.10.092.
    1. Magyar-Russell G, Thombs BD, Cai JX, et al. The prevalence of anxiety and depression in adults with implantable cardioverter defibrillators: a systematic review. J Psychosom Res. 2011;71:223–231. doi: 10.1016/j.jpsychores.2011.02.014.
    1. Pedersen SS, Nielsen JC, Riahi S, et al. Study design and cohort description of DEFIB-WOMEN: a National Danish Study in patients with an ICD. Pacing Clin Electrophysiol. 2016;39:1261–1268. doi: 10.1111/pace.12942.
    1. Dunbar SB, Dougherty CM, Sears SF, et al. Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and their families: a scientific statement from the American Heart Association. Circulation. 2012;126:2146–2172. doi: 10.1161/CIR.0b013e31825d59fd.
    1. Pedersen SS, van den Broek KC, Erdman RA, Jordaens L, Theuns DA. Pre-implantation implantable cardioverter defibrillator concerns and type D personality increase the risk of mortality in patients with an implantable cardioverter defibrillator. Europace. 2010;12:1446–1452. doi: 10.1093/europace/euq296.
    1. Sears SF, Jr, Conti JB. Quality of life and psychological functioning of ICD patients. Heart. 2002;87:488–493. doi: 10.1136/heart.87.5.488.
    1. Pedersen SS, Van den Broek KC, Sears J, F S. Psychological intervention following implantation of an implantable defibrillator: a review and future recommendations. Pacing Clin Electrophysiol. 2007;30:1546–1554. doi: 10.1111/j.1540-8159.2007.00905.x.
    1. Pedersen SS, van Domburg RT, Theuns DA, Jordaens L, Erdman RA. Type D personality is associated with increased anxiety and depressive symptoms in patients with an implantable cardioverter defibrillator and their partners. Psychosom Med. 2004;66:714–719. doi: 10.1097/01.psy.0000132874.52202.21.
    1. Sears SF, Serber ER, Lewis TS, et al. Do positive health expectations and optimism relate to quality-of-life outcomes for the patient with an implantable cardioverter defibrillator? J Cardpulm Rehabil. 2004;24:324–331. doi: 10.1097/00008483-200409000-00008.
    1. Timmermans I, Versteeg H, Meine M, Pedersen SS, Denollet J. Illness perceptions in patients with heart failure and an implantable cardioverter defibrillator: dimensional structure, validity, and correlates of the brief illness perception questionnaire in Dutch, French and German patients. J Psychosom Res. 2017;97:1–8. doi: 10.1016/j.jpsychores.2017.03.014.
    1. Pedersen SS, Andersen CM, Denollet J, Habibovic M. Depressive symptoms in patients with an implantable cardioverter defibrillator: does treatment expectations play a role? Gen Hosp Psychiatry. 2017;51:10–14. doi: 10.1016/j.genhosppsych.2017.12.002.
    1. Habibovic M, Versteeg H, Pelle AJ, Theuns DA, Jordaens L, Pedersen SS. Poor health status and distress in cardiac patients: the role of device therapy vs. underlying heart disease. Europace. 2013;15:355–361. doi: 10.1093/europace/eus295.
    1. Pedersen SS, Brouwers C, Versteeg H. Psychological vulnerability, ventricular tachyarrhythmias and mortality in implantable cardioverter defibrillator patients: is there a link? Exp Rev Med Dev. 2012;9:377–388. doi: 10.1586/erd.12.31.
    1. Mastenbroek MH, Versteeg H, Jordaens L, Theuns DA, Pedersen SS. Ventricular tachyarrhythmias and mortality in patients with an implantable cardioverter defibrillator: impact of depression in the MIDAS cohort. Psychosom Med. 2014;76:58–65. doi: 10.1097/PSY.0000000000000017.
    1. Kikkenborg Berg S, Caspar Thygesen L, Hastrup Svendsen J, Vinggaard Christensen A, Zwisler AD. Anxiety predicts mortality in ICD patients: results from the cross-sectional national CopenHeartICD survey with register follow-up. Pacing Clin Electrophysiol. 2014;37:1641–1650. doi: 10.1111/pace.12490.
    1. Bertini M, Marcantoni L, Toselli T, Ferrari R. Remote monitoring of implantable devices: should we continue to ignore it? Int J Cardiol. 2015;202:368–377. doi: 10.1016/j.ijcard.2015.09.033.
    1. Guedon-Moreau L, Finat L, Boule S, et al. Validation of an organizational management model of remote implantable cardioverter-defibrillator monitoring alerts. Circ Cardiovasc Qual Outcomes. 2015;8:403–412. doi: 10.1161/CIRCOUTCOMES.114.001433.
    1. Landolina M, Perego GB, Lunati M, et al. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012;125:2985–2992. doi: 10.1161/CIRCULATIONAHA.111.088971.
    1. Versteeg H, Pedersen SS, Mastenbroek MH, et al. Patient perspective on remote monitoring of cardiovascular implantable electronic devices: rationale and design of the REMOTE-CIED study. Neth Heart J. 2014;22:423–428. doi: 10.1007/s12471-014-0587-z.
    1. Pedersen SS, Knudsen C, Dilling K, Sandgaard NCF, Johansen JB. Living with an implantable cardioverter defibrillator: patients’ preferences and needs for information provision and care options. Europace. 2017;19:983–990.
    1. Habibovic M, Denollet J, Cuijpers P, et al. Web-based distress management for implantable cardioverter defibrillator patients: a randomized controlled trial. Health Psychol. 2017;36:392–401. doi: 10.1037/hea0000451.
    1. Schulz SM, Pauli P. Internet therapy for ICD-patients. Herzschrittmacherther Elektrophysiol. 2011;22:166–173. doi: 10.1007/s00399-011-0145-y.
    1. Habibovic M, Burg MM, Pedersen SS. Behavioral interventions in patients with an implantable cardioverter defibrillator: lessons learned and where to go from here? Pacing Clin Electrophysiol. 2013;36:578–590. doi: 10.1111/pace.12108.
    1. Salmoirago-Blotcher E, Ockene IS. Methodological limitations of psychosocial interventions in patients with an implantable cardioverter-defibrillator (ICD) a systematic review. BMC Cardiovasc Disord. 2009;9:56. doi: 10.1186/1471-2261-9-56.
    1. Salmoirago-Blotcher E, Crawford SL, Carmody J, et al. Phone-delivered mindfulness training for patients with implantable cardioverter defibrillators: results of a pilot randomized controlled trial. Ann Behav Med. 2013;46:243–250. doi: 10.1007/s12160-013-9505-7.
    1. van Veldhuisen DJ, Maass AH. Telemonitoring of outpatients with heart failure: a search for the holy grail? Circulation. 2012;125:2965–2967. doi: 10.1161/CIRCULATIONAHA.112.118141.
    1. Retrum JH, Boggs J, Hersh A, et al. Patient-identified factors related to heart failure readmissions. Circ. Cardiovasc. Qual. Outcomes. 2013;6:171–177. doi: 10.1161/CIRCOUTCOMES.112.967356.
    1. Schulz KF, Altman DG, Moher D, Group C CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18. doi: 10.1186/1741-7015-8-18.
    1. Burns JL, Serber ER, Keim S, Sears SF. Measuring patient acceptance of implantable cardiac device therapy: initial psychometric investigation of the Florida Patient Acceptance Survey. J Cardiovasc Electrophysiol. 2005;16(4):384–390. doi: 10.1046/j.1540-8167.2005.40134.x.
    1. Pedersen SS, Spindler H, Johansen JB, Mortensen PT, Sears SF. Correlates of patient acceptance of the cardioverter defibrillator: cross-validation of the Florida patient acceptance survey in Danish patients. Pacing Clin Electrophysiol. 2008;31:1168–1177. doi: 10.1111/j.1540-8159.2008.01158.x.
    1. EuroQol-group Euroqol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Brandt CJ, Søgaard GI, Clemensen J, Søndergaard J, Nielsen JB. Successful e-health coaching require with an empathic relationship – A qualitative interview study. J Med Internet Res. 2018. In Press.
    1. Lichtman JH, Froelicher ES, Blumenthal JA, et al. Depression as a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and recommendations: a scientific statement from the American Heart Association. Circulation. 2014;129:1350–1369. doi: 10.1161/CIR.0000000000000019.
    1. Piotrowicz K, Noyes K, Lyness JM, et al. Physical functioning and mental well-being in association with health outcome in patients enrolled in the multicenter automatic defibrillator implantation trial II. Eur Heart J. 2007;28:601–607. doi: 10.1093/eurheartj/ehl485.
    1. Razykov I, Ziegelstein RC, Whooley MA, Thombs BD. The PHQ-9 versus the PHQ-8--is item 9 useful for assessing suicide risk in coronary artery disease patients? Data from the heart and soul study. J Psychosom Res. 2012;73:163–168. doi: 10.1016/j.jpsychores.2012.06.001.
    1. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Chen P, Lin KC, Liing RJ, Wu CY, Chen CL, Chang KC. Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation. Qual Life Res. 2016;25:1585–1596. doi: 10.1007/s11136-015-1196-z.
    1. Pedersen SS, Denollet J, de Jonge P, Simsek C, Serruys PW, van Domburg RT. Brief depression screening with the PHQ-2 associated with prognosis following percutaneous coronary intervention with paclitaxel-eluting stenting. J Gen Intern Med. 2009;24:1037–1042. doi: 10.1007/s11606-009-1054-1.
    1. Pedersen SS, Schmidt T, Skovbakke SJ, et al. A personalized and interactive web-based health care innovation to advance the quality of life and Care of Patients with Heart Failure (ACQUIRE-HF): a mixed methods feasibility study. JMIR Res Protoc. 2017;6:e96. doi: 10.2196/resprot.7110.
    1. Naslund JA, Aschbrenner KA, Marsch LA, Bartels SJ. The future of mental health care: peer-to-peer support and social media. Epidemiol Psychiatr Sci. 2016;25(2):113–122. doi: 10.1017/S2045796015001067.
    1. Young C. Community management that works: how to build and sustain a thriving online health community. J Med Internet Res. 2013;15(6):e119. doi: 10.2196/jmir.2501.
    1. Matzah U, Rooks G. Styles of moderation in online health and support communities: an experimental comparison of their acceptance and effectiveness. Comput. Hum. Behav. 2014;36:65–75. doi: 10.1016/j.chb.2014.03.043.
    1. Pedersen SS, Spek V, Theuns DAMJ, et al. Rationale and design of WEBCARE: a randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life. Trials. 2009;10:120. doi: 10.1186/1745-6215-10-120.
    1. Habibovic M, Denollet J, Cuijpers P, et al. E-health to manage distress in patients with an implantable cardioverter-defibrillator: primary results of the WEBCARE trial. Psychosom Med. 2014;76:593–602. doi: 10.1097/PSY.0000000000000096.
    1. The Institute of Medicine . Crossing the quality chasm: a new health system for the 21st century. Washington D.C.: National Academy Press; 2001.
    1. Krumholz HM. Patient-centered medicine: the next phase in health care. Circ Cardiovasc Qual Outcomes. 2011;4:374–375. doi: 10.1161/CIRCOUTCOMES.111.962217.
    1. Krumholz HM, Peterson ED, Ayanian JZ, et al. Report of the National Heart, Lung, and Blood Institute working group on outcomes research in cardiovascular disease. Circulation. 2005;111:3158–3166. doi: 10.1161/CIRCULATIONAHA.105.536102.
    1. Weintraub WS, Spertus JA, Kolm P, et al. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008;359:677–687. doi: 10.1056/NEJMoa072771.
    1. Rumsfeld JS, Alexander KP, Goff DCJ, et al. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013;127:2233–2249. doi: 10.1161/CIR.0b013e3182949a2e.
    1. Anker SD, Agewall S, Borggrefe M, et al. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J. 2014;35:2001–2009. doi: 10.1093/eurheartj/ehu205.
    1. Hróbjartsson A, Emanuelsson F, Skou Thomsen AS, Hilden J, Brorson S. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol. 2014;43:1271–1283.

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