A web-based intervention for patients with an implantable cardioverter defibrillator - A qualitative study of nurses' experiences (Data from the ACQUIRE-ICD study).

Objective: The aim of this study was to explore cardiac nurses' experiences with a comprehensive web-based intervention for patients with an implantable cardioverter defibrillator. Methods: We conducted an explorative qualitative study based on individual semi-structured interviews with 9 cardiac nurses from 5 Danish university hospitals. Results: We found one overall theme: "Between traditional nursing and modern eHealth". This theme was derived from the following six categories: (1) comprehensive content in the intervention, (2) patient-related differences in engagement, (3) following the protocol is a balancing act, (4) online communication challenges patient contact, (5) professional collaboration varies, and (6) an intervention with potential. Cardiac nurses were positive towards the web-based intervention and believe it holds a large potential. However, they felt challenged by not having in-person and face-to-face contact with patients, which they found valuable for assessing patients' wellbeing and psychological distress. Conclusion: Specific training in eHealth communication seems necessary as web-based care entails a shift in the nursing role and requires a different way of communication.InnovationFocusing on the user experience in web-based care from the perspective of cardiac nurses is innovative, and by applying implementation science this leads to new knowledge to consider when developing and implementing web-based care.

Anxiety and depression as risk factors for ICD shocks and mortality in patients with an implantable cardioverter defibrillator - A systematic review.

OBJECTIVE: To examine associations between baseline anxiety and depression and occurrence of ICD shocks and risk of mortality in patients with an implantable cardioverter defibrillator (ICD). METHOD: We systematically searched EMBASE, PubMed, PsycINFO, and CINAHL for eligible studies fulfilling the predefined criteria. RESULTS: We included 37 studies based on 25 different cohorts following 35,003 participants for up to seven years. We observed no association between baseline anxiety nor depression and the occurrence of ICD shocks. More than half of the identified studies (respectively 56% and 60%) indicated a significant association between baseline anxiety or depression and increased risk of mortality (anxiety: n = 5, ranging from Hazard ratios (HR):1.02 [Confidence intervals (CI) 95% 1.00-1.03] to HR:3.45 [CI 95% 1.57-7.60]; depression: n = 6, ranging from HR:1.03 [CI 95% 1.00-1.06] to HR:2.10 [CI 95% 1.44-3.05]). We found a significant association between high methodological quality of the primary study and the detection of a significant association (p < 0.01). CONCLUSIONS: Baseline anxiety and depression are associated with increased risk of mortality in patients with an ICD, but not with occurrence of ICD shocks. Inclusion of baseline anxiety and depression in risk stratification of mortality may be warranted.

Development of an internet-delivered program and platform for the treatment of depression and anxiety in patients with ischemic heart disease in eMindYourHeart.

To design and evaluate a mental health treatment program and internet-based delivery platform for patients with ischemic heart disease (IHD) attending cardiac rehabilitation with the aim of reducing the risks associated with anxiety and/or depression. Patients diagnosed with IHD and comorbid anxiety and/or depression. Participatory design of treatment program and internet platform through staged inclusion of participants in two groups. Group 1 was enrolled as co-researchers with prolonged engagement in the project. Group 2 participated only in the pilot evaluation workshop. Three patients were included in Group 1, two patients in Group 2. Inclusion of patients proved challenging, but the extended collaboration with co-researchers yielded valuable circumstantial insight and resulted in the design of a novel nine-module treatment program. Additionally, the inclusion of two participant groups helped shape the development of an internet platform based on an open-source content management system. Our grouped participation method contributes with several recommendations and reflections of advantages of this approach. Collaboration with co-researchers helped us gain a deeper understanding of the impact of language on self-perception and potential stigma. Prolonged participation led to a higher level of trust and familiarity, which enabled uncovering of issues otherwise hidden.

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol.

BACKGROUND: One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care. METHODS: eMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness. DISCUSSION: To our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as "one package" to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful. Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].

Internet-based treatment of anxiety and depression in patients with ischaemic heart disease attending cardiac rehabilitation: a feasibility study (eMindYourHeart).

Aims: Anxiety and depression are prevalent in 20% of patients with ischaemic heart disease (IHD); however, treatment of psychological conditions is not commonly integrated in cardiac rehabilitation (CR). Internet-based psychological treatment holds the potential to bridge this gap. To examine the feasibility of an eHealth intervention targeting anxiety and depression in patients with IHD attending CR. Methods and results: We used a mixed-methods design, including quantitative methods to examine drop-out and change in anxiety and depression scores, and qualitative methods (thematic analysis) to evaluate patients' and nurses' experiences with the intervention. The therapist-guided intervention consisted of 12 modules provided via a web-based platform. The primary outcome was drop-out, with a drop-out rate <25% considered acceptable. Patients were considered as non-drop-out if they completed ≥5 modules. Out of 60 patients screened positive for anxiety and/or depression, 29 patients were included. The drop-out rate was 24% (7/29). Patients had a mean improvement in anxiety and depression scores of 5.5 and 4.6, respectively. On average, patients had 8.0 phone calls with their therapist and 19.7 written messages. The qualitative analysis of patients' experiences identified four themes: treatment platform, intervention, communication with therapist, and personal experience. Patients were positive towards the intervention, although some found the assignments burdensome. From the nurses, we identified three themes: intervention, inclusion procedure, and collaboration with study team. The nurses were positive, however, due to limited time some struggled with the inclusion procedure. Conclusion: Integrating an eHealth intervention in CR is feasible and the drop-out rate acceptable.

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. 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://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

Body image concerns in patients with an implantable cardioverter defibrillator: A scoping review.

BACKGROUND: Patients with an implantable cardioverter defibrillator (ICD) retain a scar and a bump at the site of implant. This may lead to body image concerns (BICs) that influence patients' quality of life. Few studies have examined the prevalence and impact of BICs postimplant, prompting us to conduct a scoping review of the field. METHODS: We searched the Medline, Embase, PsycINFO, and Cinahl databases in August 2016 and repeated in May 2017. Included were studies reporting on patients ≥ 18 years, an ICD implant (transvenous, subcutaneous, or ICD with cardiac resynchronization therapy [CRT-D]), reporting on BICs, and published in peer-reviewed English-language journals. We excluded nonsystematic reviews, opinion pieces/letters, case studies, conference abstracts, PhD dissertations, protocol papers, studies of ICD shock treatment of atrial fibrillation, and of abdominally or submammary implanted ICDs. RESULTS: A total of 40 articles were included: 16 qualitative and 24 quantitative. None of the included studies had BICs as their primary endpoint. Results showed that BICs are present in various degrees in the ICD population and can be attributed to the visibility of the ICD (the scar and bump). Women and younger patients had greater problems with BICs, although men also had concerns. Two items of the "Florida Patient Acceptance Survey" were the most frequently used to assess BICs. CONCLUSION: BICs were present among ICD patients, but the degree of impact on their lives varied. There is a need for developing a BICs questionnaire to examine the prevalence of BICs and the potential impact on patients' lives in longitudinal studies.