Implantable cardioverter defibrillator (ICD) therapy is the first-line of treatment for the primary and secondary prevention of sudden cardiac death [1]. Since the early primary and secondary prevention trials were published in the 1990’s, demonstrating risk reductions in mortality ranging from 26% and higher, depending on the indication and sub-population [2, 3], the implantation rate has increased substantially. The implantation rate now seems to have stabilised in Western and Northern European countries, while the implantation rate has continued to rise in Eastern European countries [4]. In 2016, the mean number of ICD implantations in Europe was 101 per million inhabitants [4].

The majority of patients implanted with an ICD do well [5], despite ICD therapy being associated with risk of procedural and device-related complications (e.g. infection, lead dislocation, device and hardware malfunctioning, and inappropriate shocks). However, a subset of patients (20%) have difficulties with psychological adjustment post implant and report significant levels of anxiety and depression and poor quality of life (QoL) [6, 7]. Poor patient-reported outcomes may in part be attributed to shocks and fear of shocks [8, 9], which may lead to avoidance behaviours, a sedentary lifestyle, and sexual problems. [10] However, other factors may play an equal or larger role than ICD-related aspects. These include the psychological profile of the patient (e.g. Type D personality [11, 12], lack of optimism [13]), illness perceptions [14], treatment expectations [15], and the underlying disease (e.g. symptomatic heart failure) [16]. Managing patients’ psychological morbidity, although important, is often ignored, even though depression and anxiety have been associated with increased risk of mortality and in some studies with ventricular tachyarrthmias despite state-of-the-art treatment with the ICD [17‐19].

In the last decade, we have witnessed a change in the management of ICD patients, with face-to-face outpatient visits largely being replaced by remote monitoring [20], although variability exists between countries. Remote monitoring enables the ICD clinic to detect abnormal heart rhythms and problems with the device faster, with demonstrated clinical and economic advantages [21], although we know less about its impact on patients’ QoL. [22, 23] Despite the convincing clinical and economic advantages this may have led to unrecognised gaps in patients’ quality of care [24]. Due to less patient-nurse and patient-physician interactions, it has become more difficult to identify vulnerable patients who need additional support and follow-up. This is further complicated by the fact that in Denmark and many other countries across the world, patients are not screened for psychological morbidity as part of clinical cardiology practice nor is any treatment for psychological morbidity available in the hospital setting. Patients may also be hesitant to contact the clinic outside of scheduled visits in order not to burden the care team. When examining patients’ preferences and needs for care options that are not part of standard practice, the majority of patients with ICD indicated that they would have preferred to receive continuous feedback via remote monitoring and also to have more interaction with theire care team [24]. Taken together, this may impede the transition to living successfully with the ICD for patients who have difficulties with psychological adjustment after implant.

Intervention trials targeting symptoms of depression and anxiety in the ICD population have largely used cognitive behavioral therapy, relaxation and mindfulness techniques, supplemented with telephone support, education and exercise, and online therapies, as single, one-time interventions [25, 26]. Although some of these have shown promise, with the largest effects found for cognitive behavioral therapy, the majority have been plagued by methodological shortcomings and included relatively small sample sizes [27‐29]. The complexity of the issues that patients with an ICD deal with may warrant a more comprehensive intervention that is more patient-tailored and facilitates patient empowerment. As indicated by others, there is a need to continue to search for successful care modalities in order to ensure that patients are able to live the best possible life with their device and disease [30]. This requires “…a shift from individual blame toward an empowerment and systems approach that considers the big picture” [31].

One strategy for meeting these needs are asynchronous, web-based strategies. Using an eHealth approach that enables patients to interact at a time and place of their convenience may have distinct advantages, in particular for patients who have to return to work after implantation. Hence, to address these gaps in evidence and clinical practice, we designed the ACQUIRE-ICD study (A personalised and interactive web-based health care innovation to AdvanCe the QUalIty of life and caRE of patients with an Implantable Cardioverter Defibrillator). A full description of the intervention is described in the methods. ACQUIRE-ICD will formally evaluate the effectiveness of the comprehensive and interactive ACQUIRE-ICD eHealth intervention on patient-reported and clinical outcomes and the cost-effectiveness as add-on to usual care as compared to usual care alone.

In the multi-center WEBCARE study that was conducted in the Netherlands, we previously evaluated the effectiveness of a simpler online behavioural treatment that was focused on the treatment of anxiety and depression [47, 48]. To our knowledge, the ACQUIRE-ICD study is the first study to evaluate the effectiveness and cost-effectiveness of a comprehensive interactive eHealth intervention in patients implanted with an ICD or CRT-D. The intervention represents an innovative and sustainable paradigm shift of care for patients with an ICD, as it promotes and facilitates that patients become active participants in the management of their own disease. It addresses the need for a more patient-tailored disease-management approach with care being defined by individual patients’ needs and preferences, and extra resources being allocated to those patients who need it the most. By systematically incorporating the patient perspective and patient tools in routine clinical care, the ACQUIRE-ICD study adheres to the recommendations of the American Institute of Medicine for improving the health care system of the twenty-first century to a system that provides consistent and high-quality care that is patient-centred. [49] As indicated in a recent editorial, a patient-centred approach may be paramount in order to advance the quality of care: “The practice of medicine has evolved from supposition based to science- and evidence-based, often extrapolating laboratory science to the bedside. However, studies that include patient outcomes are showing, with discomforting frequency, that strategies once considered optimal often fall short of their promise when success is defined as an improvement in what the patient experiences” [50]. Relying on a patient-centred approach, tools and outcomes may not only lead to greater patient compliance, increase patient treatment satisfaction and wellbeing but also improved prognosis [51, 52].

The current study has some important strengths and some limitations. One of the strengths of the current study relates to the design as a multi-center national study, as all 6 ICD implanting centers in Denmark are participating and recruiting patients. In addition, study endpoints include not only clinical outcomes and cost-effectiveness but also patient-reported outcomes, as advocated both by the American Heart Association [53] and the European Society of Cardiology [54], when evaluating the effects of clinical trials. A limitation is that it is not possible to blind patients to their condition and whether they are randomised to the intervention plus usual care versus usual care alone. Lack of blinding may lead to bias and exaggeration of the effect size [55].

This article presents the study protocol of the ACQUIRE-ICD study, a national multi-center randomised controlled trial that will evaluate the effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes and the cost-effectiveness as add-on to usual care as compared to usual care alone. The ACQUIRE-ICD care innovation promotes and facilitates that patients become more active participants in the management of their own disease, and as such addresses the need for a more patient-centered disease-management approach.