Healthy Ageing Through Internet Counselling in the Elderly: the HATICE randomised controlled trial for the prevention of cardiovascular disease and cognitive impairment

Abstract

IntroductionCardiovascular disease and dementia share a number of risk factors including hypertension, hypercholesterolaemia, smoking, obesity, diabetes and physical inactivity. The rise of eHealth has led to increasing opportunities for large-scale delivery of prevention programmes encouraging self-management. The aim of this study is to investigate whether a multidomain intervention to optimise self-management of cardiovascular risk factors in older individuals, delivered through an coach-supported interactive internet platform, can improve the cardiovascular risk profile and reduce the risk of cardiovascular disease and cognitive decline.Methods and analysisHATICE is a multinational, multicentre, prospective, randomised, open-label blinded end point (PROBE) trial with 18 months intervention. Recruitment of 2600 older people (≥65 years) at increased risk of cardiovascular disease will take place in the Netherlands, Finland and France. Participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of vascular risk factors, with remote support by a coach. Participants in the control group will have access to a static internet platform with basic health information.The primary outcome is a composite score based on the average z-score of the difference between baseline and 18 months follow-up values of systolic blood pressure, low-density-lipoprotein and body mass index. Main secondary outcomes include the effect on the individual components of the primary outcome, the effect on lifestyle-related risk factors, incident cardiovascular disease, mortality, cognitive functioning, mood and cost-effectiveness.Ethics and disseminationThe study was approved by the medical ethics committee of the Academic Medical Center in Amsterdam, the Comité de Protection des Personnes Sud Ouest et Outre Mer in France and the Northern Savo Hospital District Research Ethics Committee in Finland.We expect that data from this study will result in a manuscript published in a peer-reviewed clinical open access journal.Trial registration numberISRCTN48151589.

Effectiveness of an intensive intervention to improve lifestyles in people with intermediate cardiovascular risk (DATE study): Study protocol for a randomized controlled trial

“…There is limited evidence on the efficacy of interventions designed to simultaneously address multiple risk behaviours in a primary care setting. It seems that multifactorial interventions produce small changes in lifestyle and if maintained over time, they could lead to a significant improvement in cardiovascular risk, quality of life and cognitive decline (Goldstein et al., ; Richard et al., ; Sweet & Fortier, ). However, it is still not clear whether it is more effective to use group or individual interventions in simultaneously addressing various risk factors (Bayley et al., ).…”

Mobile health and cardiac rehabilitation in older adults

“…The SMArTVIEW trial (Self‐MAnagemenT‐VIsion for patient EmpoWerment), currently ongoing in the United Kingdom, will analyze whether Bluetooth enabled monitoring devices and mHealth‐delivered educational materials will optimize the ability of older adults following cardiac surgery to recognize when they require medical attention with hopes of improving postoperative outcomes . Also ongoing, the HATICE trial (Healthy Ageing Through Internet Counselling in the Elderly) will provide older adults at high risk for CVD with an interactive internet platform with educational materials and remote support by a coach with the goal of optimizing risk factors …”

Challenges and recommendations for the health-economic evaluation of primary prevention programmes for dementia

“…These include several drugs under development to modify Alzheimer's disease (AD) by targeting amyloid, and multidomain interventions targeting modifiable risk factors by means of lifestyle and cardiovascular disease management (Winblad et al, 2016). The latter has been evaluated by various trials (Ngandu et al, 2015;Richard et al, 2016;Vellas et al, 2014) on the primary prevention of dementia before the first dementia-related symptoms occur. They include the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study, which found that people aged 60-77 who were at risk for dementia, with normal or slightly diminished cognition, and received a multidomain intervention (consisting of diet, exercise, cognitive training and vascular risk monitoring), showed an 0.20 improvement in the Z-score of a neuropsychological test battery after two years, which was more than the control group (Ngandu et al, 2015).…”