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

Role of cellular senescence and NOX4-mediated oxidative stress in systemic sclerosis pathogenesis.

Systemic sclerosis (SSc) is a systemic autoimmune disease characterized by progressive fibrosis of skin and numerous internal organs and a severe fibroproliferative vasculopathy resulting frequently in severe disability and high mortality. Although the etiology of SSc is unknown and the detailed mechanisms responsible for the fibrotic process have not been fully elucidated, one important observation from a large US population study was the demonstration of a late onset of SSc with a peak incidence between 45 and 54 years of age in African-American females and between 65 and 74 years of age in white females. Although it is not appropriate to consider SSc as a disease of aging, the possibility that senescence changes in the cellular elements involved in its pathogenesis may play a role has not been thoroughly examined. The process of cellular senescence is extremely complex, and the mechanisms, molecular events, and signaling pathways involved have not been fully elucidated; however, there is strong evidence to support the concept that oxidative stress caused by the excessive generation of reactive oxygen species may be one important mechanism involved. On the other hand, numerous studies have implicated oxidative stress in SSc pathogenesis, thus, suggesting a plausible mechanism in which excessive oxidative stress induces cellular senescence and that the molecular events associated with this complex process play an important role in the fibrotic and fibroproliferative vasculopathy characteristic of SSc. Here, recent studies examining the role of cellular senescence and of oxidative stress in SSc pathogenesis will be reviewed

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)

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 (F 2,146.6=9.99; P<.001), which was similar for CAU and the intervention group (F 1,149.9=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 (F 1,149.0=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

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

Personalized eHealth program for lifestyle change:results from the do cardiac health advanced new generated ecosystem (do CHANGE 2) randomized controlled trial

\u3cp\u3eOBJECTIVE: Unhealthy lifestyle 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 CHANGE 2 intervention and evaluates effects on: 1) lifestyle, and 2) quality of life over time.\u3c/p\u3e\u3cp\u3eMETHODS: 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-behaviour assessment technologies for six months combined with a 3-month behavioural intervention program. Linear Mixed Models (LMM) analysis wERE used to evaluate the intervention effects and latent class analysis (LCA) was used for secondary subgroup analysis.\u3c/p\u3e\u3cp\u3eRESULTS: LMM analysis showed significant intervention effects for lifestyle behaviour (Finteraction(2,138.5)=5.97, p =.003), with improvement of lifestyle behaviour 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) were found. Secondary LCA revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible.\u3c/p\u3e\u3cp\u3eCONCLUSION: The personalized eHealth intervention resulted in significant improvements in lifestyle. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioural intervention program. Incorporating eHealth lifestyle programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit.\u3c/p\u3e\u3cp\u3eTRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03178305.\u3c/p\u3

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 lifestyle 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 CHANGE 2 intervention and evaluates effects on: 1) lifestyle, and 2) 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-behaviour assessment technologies for six months combined with a 3-month behavioural intervention program. Linear Mixed Models (LMM) analysis wERE used to evaluate the intervention effects and latent class analysis (LCA) was used for secondary subgroup analysis. RESULTS: LMM analysis showed significant intervention effects for lifestyle behaviour (Finteraction(2,138.5)=5.97, p =.003), with improvement of lifestyle behaviour 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) were found. Secondary LCA revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible. CONCLUSION: The personalized eHealth intervention resulted in significant improvements in lifestyle. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioural intervention program. Incorporating eHealth lifestyle 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