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

Abstract

BackgroundIn 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.MethodsThe 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.DiscussionThe 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 registrationThe trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [NCT02976961].

Mobile health and implantable cardiac devices: Patients' expectations

“…In the specific field of ICDs, the ACQUIRE-ICD study (a personalised and interactive web-based healthcare innovation to AdvanCe the QUalIty of life and caRE of patients with an Implantable Cardioverter Defibrillator) is currently ongoing to investigate the effectiveness of eHealth interventions on health status (generic and disease-specific), patient empowerment and ICD concerns. 15…”

“…First of all, our patients expressed that they are willing to be able to have a direct contact with their healthcare professionals: probably the RM technology was felt to be a reduction in patient–nurse and patient–physician interaction leading to a fall in the perception of care quality and lower patients' adaptation to living successfully with the ICD. 9,15 Furthermore, the strength of text messaging-based programmes for patients is probably overestimated. This new technology is an exciting growing field in healthcare delivery due to its potential low cost, ubiquity and perspective for wider dissemination and equal accessibility.…”

What do our patients expect of mobile health?

“…8 The ACQUIRE-ICD (A personalised and interactive Webbased healthcare innovation to AdvanCe the QUalIty of life and caRE of patients with an Implantable Cardioverter Defibrillator) study is currently ongoing to investigate the effectiveness of e-Health intervention on health status (generic and disease-specific), patient empowerment and ICD concerns. 9 We should always remember, however, that behind all of this stands the individual patient/customer, who expects to find ICT supporting modern healthcare delivery, facilitating more personalised and personcentred care at the right time and in the right place.…”

“…8 The ACQUIRE-ICD (A personalised and interactive Web-based healthcare innovation to AdvanCe the QUalIty of life and caRE of patients with an Implantable Cardioverter Defibrillator) study is currently ongoing to investigate the effectiveness of e-Health intervention on health status (generic and disease-specific), patient empowerment and ICD concerns. 9…”

Mobile health para portadores de dispositivos cardíacos eletrônicos implantáveis: ensaio clínico randomizado ApPaceMove

“…Conclui-se então que o ACQUIRE-ICD facilitou que os pacientes se tornassem mais ativos na gestão da sua doença, e sugere a realização de abordagens mais centradas no pacientes. 71 Em contrapartida, Shen et al, conduziu um ensaio clínico randomizado, com o objetivo de examinar os efeitos de orientações realizados por ligação telefônica, pela equipe de enfermagem sobre resultados de saúde, como QdV, ansiedade, depressão, e auto cuidado, e ainda a incidência de complicações no pós-operatório em pacientes após implante de marcapasso cardíaco. Não foi identificado diferença após essa intervenção nos desfechos de ansiedade e depressão analisados pelo HADS.…”