Instrumental, Affective, and Patient-Centered Communication Between Cardiologists and Patients with Low Socioeconomic Status: An Observational Study.

One of the essential elements in managing health is having adequate communication with health care providers. Unfortunately, patients with a low socioeconomic status (SES) often experience less adequate communication with their doctor. In the current study, we explore and compare the communication of both doctors and patients from lower and higher sociodemographic backgrounds on three factors: instrumental, affective, and patient-centered communication. In total, 45 cardiology consultations were observed, transcribed, and coded (16 low-SES, 16 middle-SES, 13 high-SES). Our analyses showed that, compared to higher-SES patients, low-SES patients voiced less of their concerns, answered questions of the doctor more often with one word, and expressed less utterances overall. Naturally, we found that doctors expressed more utterances overall toward low-SES patients. For doctors, no differences regarding instrumental, affective, or patient-centered communication were found. These findings suggest that low-SES patients are more passive communicators and communication differences based on SES exist predominantly for patients' communication. The revealed communication differences may lead to a less adequate interaction and potentially worse patient outcomes, further increasing the socioeconomic health gap. Hence, doctors should become even more aware of socioeconomic patient communication differences so that they can appropriately encourage low-SES patients to become more active communicators.

Living Lab Data of Patient Needs and Expectations for eHealth-Based Cardiac Rehabilitation in Germany and Spain From the TIMELY Study: Cross-Sectional Analysis.

BACKGROUND: The use of eHealth technology in cardiac rehabilitation (CR) is a promising approach to enhance patient outcomes since adherence to healthy lifestyles and risk factor management during phase III CR maintenance is often poorly supported. However, patients' needs and expectations have not been extensively analyzed to inform the design of such eHealth solutions. OBJECTIVE: The goal of this study was to provide a detailed patient perspective on the most important functionalities to include in an eHealth solution to assist them in phase III CR maintenance. METHODS: A guided survey as part of a Living Lab approach was conducted in Germany (n=49) and Spain (n=30) involving women (16/79, 20%) and men (63/79, 80%) with coronary artery disease (mean age 57 years, SD 9 years) participating in a structured center-based CR program. The survey covered patients' perceived importance of different CR components in general, current usage of technology/technical devices, and helpfulness of the potential features of eHealth in CR. Questionnaires were used to identify personality traits (psychological flexibility, optimism/pessimism, positive/negative affect), potentially predisposing patients to acceptance of an app/monitoring devices. RESULTS: All the patients in this study owned a smartphone, while 30%-40% used smartwatches and fitness trackers. Patients expressed the need for an eHealth platform that is user-friendly, personalized, and easily accessible, and 71% (56/79) of the patients believed that technology could help them to maintain health goals after CR. Among the offered components, support for regular physical exercise, including updated schedules and progress documentation, was rated the highest. In addition, patients rated the availability of information on diagnosis, current medication, test results, and risk scores as (very) useful. Of note, for each item, except smoking cessation, 35%-50% of the patients indicated a high need for support to achieve their long-term health goals, suggesting the need for individualized care. No major differences were detected between Spanish and German patients (all P>.05) and only younger age (P=.03) but not sex, education level, or personality traits (all P>.05) were associated with the acceptance of eHealth components. CONCLUSIONS: The patient perspectives collected in this study indicate high acceptance of personalized user-friendly eHealth platforms with remote monitoring to improve adherence to healthy lifestyles among patients with coronary artery disease during phase III CR maintenance. The identified patient needs comprise support in physical exercise, including regular updates on personalized training recommendations. Availability of diagnoses, laboratory results, and medications, as part of a mobile electronic health record were also rated as very useful. TRIAL REGISTRATION: ClinicalTrials.gov NCT05461729; https://clinicaltrials.gov/study/NCT05461729.

Technological Innovations in Biobehavioral and Psychosomatic Medicine.

ABSTRACT: The role of technological innovations in health care has increased over the past years and will continue to improve the diagnosis, monitoring, and treatment of various physical and mental disorders. In biobehavioral and psychosomatic medicine, the use of technology has also increased in both research and clinical contexts. The articles in the current special issue of Psychosomatic Medicine focus on technological solutions that have been applied to patient-monitoring/assessment (health-related behaviors and vital functioning) and treatment (ehealth and mhealth interventions). Although such solutions are promising and considered acceptable by patients and health care providers, important barriers have also been identified regarding the implementation of these technological advances. Topics addressed in this issue cover the following themes: the use of biological and behavioral sensors that are linked to user smartphones, technological innovations in clinical conditions (asthma, alcohol-associated liver disease, and chronic pain), the use of virtual humans in clinical settings, digital mental health interventions, and the importance of reducing health disparities in the development and implementation of technological innovation. These topics are critically relevant to the field of biobehavioral and psychosomatic medicine and provide future directions for research and clinical practice.

Patients Managing Their Medical Data in Personal Electronic Health Records: Scoping Review.

BACKGROUND: Personal electronic health records (PEHRs) allow patients to view, generate, and manage their personal and medical data that are relevant across illness episodes, such as their medications, allergies, immunizations, and their medical, social, and family health history. Thus, patients can actively participate in the management of their health care by ensuring that their health care providers have an updated and accurate overview of the patients' medical records. However, the uptake of PEHRs remains low, especially in terms of patients entering and managing their personal and medical data in their PEHR. OBJECTIVE: This scoping review aimed to explore the barriers and facilitators that patients face when deciding to review, enter, update, or modify their personal and medical data in their PEHR. This review also explores the extent to which patient-generated and -managed data affect the quality and safety of care, patient engagement, patient satisfaction, and patients' health and health care services. METHODS: We searched the MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, Web of Science, and Google Scholar web-based databases, as well as reference lists of all primary and review articles using a predefined search query. RESULTS: Of the 182 eligible papers, 37 (20%) provided sufficient information about patients' data management activities. The results showed that patients tend to use their PEHRs passively rather than actively. Patients refrain from generating and managing their medical data in a PEHR, especially when these data are complex and sensitive. The reasons for patients' passive data management behavior were related to their concerns about the validity, applicability, and confidentiality of patient-generated data. Our synthesis also showed that patient-generated and -managed health data ensures that the medical record is complete and up to date and is positively associated with patient engagement and patient satisfaction. CONCLUSIONS: The findings of this study suggest recommendations for implementing design features within the PEHR and the construal of a dedicated policy to inform both clinical staff and patients about the added value of patient-generated data. Moreover, clinicians should be involved as important ambassadors in informing, reminding, and encouraging patients to manage the data in their PEHR.

Personalized eHealth Program for Life-style Change: Results From the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial.

OBJECTIVE: Unhealthy life-style factors have adverse outcomes in cardiac patients. However, only a minority of patients succeed to change unhealthy habits. Personalization of interventions may result in critical improvements. The current randomized controlled trial provides a proof of concept of the personalized Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) 2 intervention and evaluates effects on a) life-style and b) quality of life over time. METHODS: Cardiac patients (n = 150; mean age = 61.97 ± 11.61 years; 28.7% women; heart failure, n = 33; coronary artery disease, n = 50; hypertension, n = 67) recruited from Spain and the Netherlands were randomized to either the "Do CHANGE 2" or "care as usual" group. The Do CHANGE 2 group received ambulatory health-behavior assessment technologies for 6 months combined with a 3-month behavioral intervention program. Linear mixed-model analysis was used to evaluate the intervention effects, and latent class analysis was used for secondary subgroup analysis. RESULTS: Linear mixed-model analysis showed significant intervention effects for life-style behavior (Finteraction(2,138.5) = 5.97, p = .003), with improvement of life-style behavior in the intervention group. For quality of life, no significant main effect (F(1,138.18) = .58, p = .447) or interaction effect (F(2,133.1) = 0.41, p = .67) was found. Secondary latent class analysis revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible. CONCLUSIONS: The personalized eHealth intervention resulted in significant improvements in life-style. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioral intervention program. Incorporating eHealth life-style programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03178305.

A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.

BACKGROUND: Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes. OBJECTIVE: This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated. METHODS: Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies. RESULTS: The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F2,146.6=9.99; P<.001), which was similar for CAU and the intervention group (F1,149.9=0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F1,149.0=0.48; P=.07). CONCLUSIONS: The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change. TRIAL REGISTRATION: ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281.

Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial.

BACKGROUND: During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques. OBJECTIVE: This study aimed to provide evidence to understand the financial consequences of implementing the "Do Cardiac Health: Advanced New Generation Ecosystem" (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease. METHODS: The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities). RESULTS: The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan. CONCLUSIONS: In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305.

Healthcare utilization in patients with first-time implantable cardioverter defibrillators (data from the WEBCARE study).

BACKGROUND: Knowledge of the level of healthcare utilization (HCU) and the predictors of high HCU use in patients with an implantable cardioverter defibrillator (ICD) is lacking. We examined the level of HCU and predictors associated with increased HCU in first-time ICD patients, using a prospective study design. METHODS: ICD patients (N = 201) completed a set of questionnaires at baseline and 3, 6, and 12 months after inclusion. A hierarchical multiple linear regression with three models was performed to examine predictors of HCU. RESULTS: HCU was highest between baseline and 3 months postimplantation and gradually decreased during 12 months follow-up. During the first year postimplantation, only depression (ß = 0.342, P = 0.002) was a significant predictor. Between baseline and 3 months follow-up, younger age (ß = -0.220, P < 0.01), New York Heart Association class III/IV (ß = 0.705, P = 0.01), and secondary indication (ß = 0.148, P = 0.05) were independent predictors for increased HCU. Between 3 and 6 months follow-up, younger age (ß = -0.151, P = 0.05) and depression (ß = 0.370, P < 0.001) predicted increased HCU. Between 6 and 12 months only depression (ß = 0.355, P = 0.001) remained a significant predictor. CONCLUSIONS: Depression was an important predictor of increased HCU in ICD patients in the first year postimplantation, particularly after 3 months postimplantation. Identifying patients who need additional care and provide this on time might better meet patients' needs and lower future HCU.

Posttraumatic stress and anxiety in patients with an implantable cardioverter defibrillator: Trajectories and vulnerability factors.

BACKGROUND: Implantable cardioverter defibrillator (ICD) therapy is the first-line treatment for the primary and secondary prevention of sudden cardiac death. Despite the unequivocal medical benefits, living with an ICD may affect patients' psychological functioning and general well-being. We examined the trajectories of symptoms of posttraumatic stress disorder (PTSD) and anxiety in patients with an ICD and the vulnerability factors associated with an increased risk of symptoms of PTSD and anxiety. METHODS: A total of 249 patients were included as part of the WEB-based distress program for implantable CARdioverter dEfibrillator patients (WEBCARE) study. Data were analyzed using Latent class analyses, with trajectories of PTSD symptomatology and anxiety examined between baseline and 12 months follow-up. RESULTS: The mean age of the sample was 58.9 ± 9.8, with the majority being male (82%). Latent Class analyses (LatentGOLD) revealed four classes with respect to PTSD symptomatology, and three classes of patients with respect to anxiety. Younger age, increased depression score at baseline, and Type D personality were all associated with increased vulnerability for posttraumatic stress and anxiety symptoms. CONCLUSION: Comparable trajectories were found for symptoms of PTSD and anxiety over time. Patients with a younger age, increased depression score at baseline, and Type D personality were especially prone to experience PTSD and anxiety symptomatology at 12 months follow-up. Due to the negative association between PTSD, anxiety, and health outcomes, it is paramount to timely identify the subset of patients who are vulnerable to experience these symptoms and provide them with personalized support.

E-health to manage distress in patients with an implantable cardioverter-defibrillator: primary results of the WEBCARE trial.

UNLABELLED: The Web-based distress management program for patients with an implantable cardioverter-defibrillator (ICD; WEBCARE) was developed to mitigate distress and enhance health-related quality of life in ICD patients. This study investigated the treatment effectiveness at 3-month follow-up for generic and disease-specific outcome measures. METHODS: Consecutive patients implanted with a first-time ICD from six hospitals in the Netherlands were randomized to either the "WEBCARE" or the "usual care" group. Patients in the WEBCARE group received a 12-week fixed, six-lesson behavioral treatment based on the problem-solving principles of cognitive behavioral therapy. RESULTS: Two hundred eighty-nine patients (85% response rate) were randomized. The prevalence of anxiety and depression ranged between 11% and 30% and 13% and 21%, respectively. No significant intervention effects were observed for anxiety (ß = 0.35; p = .32), depression (ß = -0.01; p = .98) or health-related quality of life (Mental Component Scale: ß = 0.19; p = .86; Physical Component Scale: ß = 0.58; p = .60) at 3 months, with effect sizes (Cohen d) being small (range, 0.06-0.13). There were also no significant group differences as measured with the disease-specific measures device acceptance (ß = -0.37; p = .82), shock anxiety (ß = 0.21; p = .70), and ICD-related concerns (ß = -0.08; p = .90). No differences between treatment completers and noncompleters were observed on any of the measures. CONCLUSIONS: In this Web-based intervention trial, no significant intervention effects on anxiety, depression, health-related quality of life, device acceptance, shock anxiety, or ICD-related concerns were observed. A more patient tailored approach targeting the needs of different subsets of ICD patients may be warranted. TRIAL REGISTRATION: clinicaltrials.gov. Identifier: NCT00895700.

Monitoring treatment expectations in patients with an implantable cardioverter-defibrillator using the EXPECT-ICD scale.

AIMS: Patient treatment expectations may affect cardiac outcomes; however, till date, no validated instruments have been developed to monitor treatment expectations in patients with an implantable cardioverter-defibrillator (ICD). This study evaluates the predictive value of the newly developed 10-item EXPECtations Towards ICD therapy (EXPECT-ICD) in relation to anxiety, depression, and ICD related concerns 3 months post-implant. METHODS AND RESULTS: Consecutive implanted ICD patients were included as part of the WEB-based distress management programme for ICD patients (WEBCARE) trial from six Dutch referral hospitals. The patients completed the baseline questionnaires briefly after ICD implantation. Information on clinical variables was captured from the patients' medical records. Patients' treatment expectations as assessed with the EXPECT-ICD questionnaire could best be represented with a two-factor model involving both negative (α = 0.84) and positive expectations (α = 0.77) with a score range of 0-20 for each factor. Negative treatment expectations were associated with higher levels of anxiety (ß = 0.443; P < 0.001), depression (ß = 0.506; P < 0.001), and ICD concerns (ß = 0.428; P < 0.001) 3 months post-implant after controlling for demographic and clinical factors. Positive expectations were not related to any of the distress outcomes. CONCLUSION: Negative expectations were associated with anxiety, depression, and ICD concerns 3 months post-implant. The current findings indicate that the EXPECT-ICD scale is a reliable, valid, and disease-specific measure of the treatment expectations in ICD patients. Future research needs to investigate whether addressing the patients' expectations might improve the outcome and the subjective well-being of ICD patients.

Attrition and adherence in a WEB-Based Distress Management Program for Implantable Cardioverter defibrillator Patients (WEBCARE): randomized controlled trial.

BACKGROUND: WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence. OBJECTIVE: In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE. METHODS: Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group. RESULTS: The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support. CONCLUSIONS: Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz).

Latent profiles of telehealth care satisfaction during the COVID-19 pandemic among patients with cardiac conditions in an outpatient setting.

Background: During the COVID-19 pandemic, telemedicine was advocated and rapidly scaled up worldwide. However, little is known about for whom this type of care is acceptable. Objective: To examine which patient characteristics (demographic, medical, psychosocial) are associated with telehealth care satisfaction, attitude toward telehealth, and preference regarding telehealth over time in a cardiac patient population. Methods: In total, 317 patients were recruited at the Elisabeth-TweeSteden Hospital in The Netherlands. All patients who had received telehealth care (telephone and video) in the previous 2 months were approached for participation. Baseline, 3-month, and 6-month questionnaires were administered online. A 3-step latent class analysis was conducted to identify trajectories of telehealth use over time and the possible association of the found trajectories with external variables. Results: Five trajectories (classes) were identified for satisfaction with telehealth and 4 for attitude toward telehealth. Patients with higher distress, lower physical and mental health, higher scores on pessimism, and negative affectivity were more likely to be less satisfied. Patients with no partner, more comorbidities, higher distress, lower physical and mental health, and higher scores on pessimism were more likely to hold a negative attitude toward telehealth. For the future application of telehealth, marital status, comorbidities, digital health literacy, and pessimism were significantly related. Conclusion: Results show that patients' profiles should be considered when offering telehealth care and that the "one size fits all" approach does not apply. Results can inform clinical practice on how to better implement remote health care in the future while considering a personalized approach.

Ethics of Wearable-Based Out-of-Hospital Cardiac Arrest Detection.

Out-of-hospital cardiac arrest is a major health problem, and immediate treatment is essential for improving the chances of survival. The development of technological solutions to detect out-of-hospital cardiac arrest and alert emergency responders is gaining momentum; multiple research consortia are currently developing wearable technology for this purpose. For the responsible design and implementation of this technology, it is necessary to attend to the ethical implications. This review identifies relevant ethical aspects of wearable-based out-of-hospital cardiac arrest detection according to four key principles of medical ethics. First, aspects related to beneficence concern the effectiveness of the technology. Second, nonmaleficence requires preventing psychological distress associated with wearing the device and raises questions about the desirability of screening. Third, grounded in autonomy are empowerment, the potential reidentification from continuously collected data, issues of data access, bystander privacy, and informed consent. Finally, justice concerns include the risks of algorithmic bias and unequal technology access. Based on this overview and relevant legislation, we formulate design recommendations. We suggest that key elements are device accuracy and reliability, dynamic consent, purpose limitation, and personalization. Further empirical research is needed into the perspectives of stakeholders, including people at risk of out-of-hospital cardiac arrest and their next-of-kin, to achieve a successful and ethically balanced integration of this technology in society.

Rationale and design of the BECA project: Smartwatch-based activation of the chain of survival for out-of-hospital cardiac arrest.

Aim: Out-of-hospital cardiac arrest is a major health problem, and the overall survival rate is low (4.6%-16.4%). The initiation of the current chain of survival depends on the presence of a witness of the cardiac arrest, which is not present in 29.7%-63.4% of the cases. Furthermore, a delay in starting this chain is common in witnessed out-of-hospital cardiac arrest. This project aims to reduce morbidity and mortality due to out-of-hospital cardiac arrest by developing a smartwatch-based solution to expedite the chain of survival in the case of (un)witnessed out-of-hospital cardiac arrest. Methods: Within the 'Beating Cardiac Arrest' project, we aim to develop a demonstrator product that detects out-of-hospital cardiac arrest using photoplethysmography and accelerometer analysis, and autonomously alerts emergency medical services. A target group study will be performed to determine who benefits the most from this product. Furthermore, several clinical studies will be conducted to capture or simulate data on out-of-hospital cardiac arrest cases, as to develop detection algorithms and validate their diagnostic performance. For this, the product will be worn by patients at high risk for out-of-hospital cardiac arrest, by volunteers who will temporarily interrupt blood flow in their arm by inflating a blood pressure cuff, and by patients who undergo cardiac electrophysiologic and implantable cardioverter defibrillator testing procedures. Moreover, studies on psychosocial and ethical acceptability will be conducted, consisting of surveys, focus groups, and interviews. These studies will focus on end-user preferences and needs, to ensure that important individual and societal values are respected in the design process.

Patient-reported preferences in eHealth-based cardiac rehabilitation: A qualitative investigation of behavior change techniques, barriers and facilitators.

Background: Cardiac rehabilitation (CR) reduces recurrent cardiac events and mortality in patients with cardiovascular diseases (CVD). Innovative eHealth methods can facilitate CR uptake and effectiveness by addressing barriers associated with clinic-based rehabilitation. Tailoring eHealth-based CR to patient preferences is needed to further enhance CR. Purpose: To identify preferred behavior change techniques (BCTs) as well as barriers and facilitators for the different health behaviors targeted in eHealth-based CR among patients who have been referred to CR. Methods: Thirty-nine patients were interviewed in nine focus groups in The Netherlands, Germany, and Spain. A thematic analysis, using a combined deductive and inductive approach to coding, was conducted to identify BCTs and barriers and facilitators to behavior change. Behaviors under investigation included physical activity, medication adherence, eating a cardiac healthy-diet, stress reduction and smoking cessation. Results: The perceived helpfulness of BCTs depended on the specific behavior targeted. Common barriers were negative emotional state and physical limitations. A desire to feel physically or mentally well and having experienced a cardiac life event were the most common facilitators across health behaviors. Specific BCTs, barriers and facilitators were found for each of the health behavior. Conclusions: Behavior change techniques that patients preferred for each health behavior targeted in eHealth-based CR were identified. A negative emotional state, experiencing a life event, and improving physical functioning are important barriers and facilitators in multiple behaviors targeted in eHealth-based CR programs. Additional tailoring of interventions to patient preferences for BCTs and patient-specific barriers and facilitators per health behavior could lead to further improvement of eHealth-based CR.

Anxiety and risk of ventricular arrhythmias or mortality in patients with an implantable cardioverter defibrillator.

OBJECTIVE: A subgroup of patients with an implantable cardioverter defibrillator (ICD) experiences anxiety after device implantation. The purpose of the present study was to evaluate whether anxiety is predictive of ventricular arrhythmias and all-cause mortality 1 year post ICD implantation. METHODS: A total of 1012 patients completed the state version of the State-Trait Anxiety Inventory at baseline. The end points were ventricular arrhythmias and mortality the first year after ICD implantation. RESULTS: Within the first year after ICD implantation, 19% of patients experienced a ventricular arrhythmia, and 4% died. Anxiety was associated with an increased risk of ventricular arrhythmias (hazard ratio [HR] = 1.017; 95% confidence interval [CI] = 1.005-1.028; p = .005) and mortality (HR = 1.038; 95% CI = 1.014-1.063; p = .002) in adjusted analysis. Patients with anxiety (highest tertile) had a 1.9 increased risk for ventricular arrhythmias (95% CI = 1.329-2.753; p =.001) and a 2.9 increased risk for mortality (95% CI = 1.269-6.677; p = .01) compared with patients with low anxiety (lowest tertile). Among 257 patients with cardiac resynchronization therapy, anxiety was associated with mortality (HR = 5.381; 95% CI = 1.254-23.092; p = .02) after adjusting for demographic and clinical covariates. CONCLUSIONS: Anxiety was associated with an increased risk of ventricular arrhythmias and mortality 1 year after ICD implantation, independent of demographic and clinical covariates. Monitoring and treatment of anxiety may be warranted in a selected subgroup of high-risk patients with an ICD.

Poor health status and distress in cardiac patients: the role of device therapy vs. underlying heart disease.

AIMS: Implantable cardioverter defibrillator (ICD) therapy, which includes the risk of shocks, is considered the primary culprit of reductions in patient reported outcomes (PROs; e.g. health status and distress), thereby negating the role of underlying disease severity. We examined the relative influence of living with an ICD vs. congestive heart failure (CHF) on PROs and compared (i) ICD patients without CHF (ICD only), (ii) CHF patients without an ICD (CHF-only), and (iii) CHF patients with an ICD (ICD + CHF). METHODS AND RESULTS: Separate cohorts of ICD and CHF patients (N = 435; 75% men) completed PROs at baseline, 6 and 12 months. Groups differed on physical health status only at baseline (F((2,415)) = 7.15, P = 0.001) and on anxiety at 12 months (F((2,415)) = 4.04, P = 0.01); ICD + CHF patients had the most impaired physical health status but the lowest anxiety level followed by the ICD only and CHF only patients. Congestive heart failure only patients had the most impaired mental health status and reported the highest level of anxiety as compared to the ICD only (P < 0.001) and ICD + CHF groups (P = 0.009), while the two latter groups did not differ. The effect sizes ranged from very small (0.03) to moderate-large (0.69). Groups did not differ in depression scores. CONCLUSION: Congestive heart failure patients reported worse PROs as compared to ICD patients, although the magnitude of the differences was relatively small. This suggests that the well being of patients is not necessarily negatively influenced by the implantation of an ICD, and that underlying heart disease may have at least an equal if not greater influence on PROs.

Behavioral interventions in patients with an implantable cardioverter defibrillator: lessons learned and where to go from here?

BACKGROUND: The implantable cardioverter defibrillator (ICD) is the first-line treatment for primary and secondary prevention of sudden cardiac death. A subgroup of patients experience psychological distress postimplant, and no clear evidence base exists regarding how best to address patients' needs. The aim of this critical review is to provide an overview of behavioral interventions in ICD patients to date, and to delineate directions for future research using lessons learned from the ongoing RISTA and WEBCARE trials. METHODS: We searched the PubMed and PsycInfo databases to identify reports of behavioral trials targeting distress and related factors in ICD patients published between 1980 and April 2012. RESULTS: We identified 17 trials for the review. Generally, compared to usual care, behavioral interventions were associated with reduced anxiety and depression and improved physical functioning, with effect sizes ranging from small to moderate-large (0.10-1.79 for anxiety; 0.23-1.20 for depression). Important limitations were small sample sizes and potential selection bias, hampering generalizability of the results. In addition to a need for larger trials, experiences from the RISTA and WEBCARE trials suggest that intervention trials tailored to the individual patient may be the way forward. CONCLUSIONS: Behavioral interventions show promise with respect to reducing distress in ICD patients. Large-scale intervention trials targeted to the individual needs and preferences of patients are warranted, as a "one size fits all" approach is unlikely to work for all ICD patients.

eHealth for maintenance cardiovascular rehabilitation: a systematic review and meta-analysis.

AIMS: To provide a quantitative analysis of eHealth-supported interventions on health outcomes in cardiovascular rehabilitation (CR) maintenance (phase III) in patients with coronary artery disease (CAD) and to identify effective behavioural change techniques (BCTs). METHODS AND RESULTS: A systematic review was conducted (PubMed, CINAHL, MEDLINE, and Web of Science) to summarize and synthesize the effects of eHealth in phase III maintenance on health outcomes including physical activity (PA) and exercise capacity, quality of life (QoL), mental health, self-efficacy, clinical variables, and events/rehospitalization. A meta-analysis following the Cochrane Collaboration guidelines using Review Manager (RevMan5.4) was performed. Analyses were conducted differentiating between short-term (≤6 months) and medium/long-term effects (>6 months). Effective behavioural change techniques were defined based on the described intervention and coded according to the BCT handbook. Fourteen eligible studies (1497 patients) were included. eHealth significantly promoted PA (SMD = 0.35; 95%CI 0.02-0.70; P = 0.04) and exercise capacity after 6 months (SMD = 0.29; 95%CI 0.05-0.52; P = 0.02) compared with usual care. Quality of life was higher with eHealth compared with care as usual (SMD = 0.17; 95%CI 0.02-0.32; P = 0.02). Systolic blood pressure decreased after 6 months with eHealth compared with care as usual (SMD = -0.20; 95%CI -0.40-0.00; P = 0.046). There was substantial heterogeneity in the adapted BCTs and type of intervention. Mapping of BCTs revealed that self-monitoring of behaviour and/or goal setting as well as feedback on behaviour were most frequently included. CONCLUSION: eHealth in phase III CR is effective in stimulating PA and improving exercise capacity in patients with CAD while increasing QoL and decreasing systolic blood pressure. Currently, data of eHealth effects on morbidity, mortality, and clinical outcomes are scarce and should be investigated in future studies. REGISTRATION: PROSPERO: CRD42020203578.

KEY FINDINGS: • eHealth interventions in cardiovascular rehabilitation maintenance may be used to increase physical activity and exercise capacity as well as quality of life while reducing systolic blood pressure.• Effective behavioural change techniques used in eHealth interventions may include self-monitoring of behaviour, goal setting, and feedback on behaviour; thus, future studies are needed to define effective eHealth components based on behavioural change theories and associated behavioural change techniques to assist patients with coronary artery disease.

• This paper reviews the impact of eHealth-supported interventions on health outcomes during cardiovascular rehabilitation maintenance phase III for patients with coronary artery disease, with a meta-analysis performed to differentiate between short-term (≤6 months) and medium/long-term effects (>6 months).