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.

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.

Type D personality and global positioning system tracked social behavior in patients with cardiovascular disease.

OBJECTIVE: Social behavior (e.g., loneliness, isolation) has been indicated as an important risk factor for cardiovascular disease. Recent studies show that Type D personality might be an important predictor of social behavior. Hence, the current exploratory study aims to examine, using ecological assessment, whether Type D personality is associated with a lower likelihood to engage in social encounters in patients with cardiovascular disease. METHOD: Cardiac patients who participated in the Do CHANGE (Phase 2) trial were included in current analysis. As part of the Do CHANGE intervention, real-life data were collected in the intervention group using the MOVES app, which was installed on patients' mobile phones. For a period of 6 months, Global Positioning System (GPS) data from the participating patients were collected. From the GPS data, 3 target variables were computed: (a) general activity level, (b) social variety, and (c) social opportunity. RESULTS: A total of 70 patients were included in the analysis. Patients with a Type D personality had lower scores on the "social opportunity" variable compared to non-Type D patients (F = 6.72; p = .01). Type D personality was associated with lower social participation after adjusting for depression and anxiety. No association between Type D personality and general activity or behavioral variety was observed. CONCLUSIONS: This is the first study to use an ecological measure to assess social behavior of cardiac patients with a Type D personality. Results show that Type D personality might be associated with lower social engagement, which could, in turn, partly explain its association with adverse health outcomes. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

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.

Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease.

The importance of modifying lifestyle factors in order to improve prognosis in cardiac patients is well-known. Current study aims to evaluate the effects of a lifestyle intervention on changes in lifestyle- and health data derived from wearable devices. Cardiac patients from Spain (n = 34) and The Netherlands (n = 36) were included in the current analysis. Data were collected for 210 days, using the Fitbit activity tracker, Beddit sleep tracker, Moves app (GPS tracker), and the Careportal home monitoring system. Locally Weighted Error Sum of Squares regression assessed trajectories of outcome variables. Linear Mixed Effects regression analysis was used to find relevant predictors of improvement deterioration of outcome measures. Analysis showed that Number of Steps and Activity Level significantly changed over time (F = 58.21, p < 0.001; F = 6.33, p = 0.01). No significant changes were observed on blood pressure, weight, and sleep efficiency. Secondary analysis revealed that being male was associated with higher activity levels (F = 12.53, p < 0.001) and higher number of steps (F = 8.44, p < 0.01). Secondary analysis revealed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. In conclusion results showed that physical activity increased over time and that certain subgroups of patients were more likely to have a better lifestyle behaviors based on their demographic, clinical, and psychological profile. This advocates a personalized approach in future studies in order to change lifestyle in cardiac patients.

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.

Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System ("Do Cardiac Health: Advanced New Generation Ecosystem"): Randomized Controlled Trial Protocol.

BACKGROUND: Promoting a healthy lifestyle (eg, physical activity, healthy diet) is crucial for the primary and secondary prevention of cardiac disease in order to decrease disease burden and mortality. OBJECTIVE: The current trial aims to evaluate the effectiveness of the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) service, which is developed to assist cardiac patients in adopting a healthy lifestyle and improving their quality of life. METHODS: Cardiac patients (ie, people who have been diagnosed with heart failure, coronary artery disease, and/or hypertension) will be recruited at three pilot sites (Badalona Serveis Assistencials, Badalona, Spain [N=75]; Buddhist Tzu Chi Dalin General Hospital, Dalin, Taiwan [N=100] and Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands [N=75]). Patients will be assisted by the Do Something Different (DSD) program to change their unhealthy habits and/or lifestyle. DSD has been developed to increase behavioral flexibility and subsequently adopt new (healthier) habits. In addition, patients' progress will be monitored with a number of (newly developed) devices (eg, Fitbit, Beddit, COOKiT, FLUiT), which will be integrated in one application. RESULTS: The Do CHANGE trial will provide us with new insights regarding the effectiveness of the proposed intervention in different cultural settings. In addition, it will give insight into what works for whom and why. CONCLUSIONS: The Do CHANGE service integrates new technologies into a behavior change intervention in order to change the unhealthy lifestyles of cardiac patients. The program is expected to facilitate long-term, sustainable behavioral change. TRIAL REGISTRATION: Clinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU).

Patient Perspectives on Health Data Privacy and Management: "Where Is My Data and Whose Is It?"

New technologies are increasingly evaluated for use within the clinical practice to monitor patients' medical and lifestyle data. This development could contribute to a more personalized approach to patient care and potentially improve health outcomes. To date, patient perspective on this development has mostly been neglected in the literature. Hence, this study aims to shed more light on the patient perspective on health data privacy and management. Focus groups with cardiac patients were done at the Elizabeth TweeSteden Ziekenhuis (ETZ) in the Netherlands as part of the DoCHANGE project. The focus groups were conducted using a semistructured protocol which was organized around three themes: privacy regulations, data storage, and transparency and privacy management. Five focus groups with a total of 23 patients were conducted. The majority of the patients preferred to have access to their medical data; however, the knowledge on who has access to data was limited. Patients indicated that they do not want to share their medical data with health insurance companies or the pharmaceutical industry. Furthermore, most patients do not see the added value of supplementing their medical dossier with lifestyle data. Current findings showed patients prefer access to and control over own data but that the knowledge concerning data privacy and management is limited. Sharing of non-medical health data (e.g.,, physical activity) was considered unnecessary. Future studies should address patient preferences and develop infrastructure which facilitates medical data access for patients.