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



HATICE 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.



The 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.



ISRCTN48151589.
Department of Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.
Edo
E
Richard
Department of Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Susan
S
Jongstra
Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.
Hilkka
H
Soininen
Department of Public Health and Primary Care, Cambridge Institute of Public Health, University of Cambridge, Cambridge, UK.
Carol
C
Brayne
Department of General Practice, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Eric P
EP
Moll van Charante
Department of Information and Operations Management, ESCP Europe, Paris, France.
Yannick
Y
Meiller
Vital Health Software, Ede, The Netherlands.
Bram
B
van der Groep
Department of Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Cathrien R L
CR
Beishuizen
Aging Research Center, Karolinska Institutet/Stockholm University, Stockholm, Sweden.
Francesca
F
Mangialasche
Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland.
Mariagnese
M
Barbera
Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland.
Tiia
T
Ngandu
INSERM, University of Toulouse UMR1027, Toulouse, France Department of Epidemiology and Public Health, Toulouse University Hospital, Toulouse, France.
Nicola
N
Coley
INSERM, University of Toulouse UMR1027, Toulouse, France.
Juliette
J
Guillemont
INSERM, University of Toulouse UMR1027, Toulouse, France.
Stéphanie
S
Savy
Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Marcel G W
MG
Dijkgraaf
Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Ron J G
RJ
Peters
Department of Neurology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Willem A
WA
van Gool
Institute of Clinical Medicine/Neurology, University of Eastern Finland, Kuopio, Finland Aging Research Center, Karolinska Institutet/Stockholm University, Stockholm, Sweden Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland Karolinska Institutet Center for Alzheimer Research, Stockholm, Sweden.
Miia
M
Kivipelto
INSERM, University of Toulouse UMR1027, Toulouse, France Department of Epidemiology and Public Health, Toulouse University Hospital, Toulouse, France.
Sandrine
S
Andrieu
D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D060825:Cognitive Dysfunction / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000379:methods*; D005260:Female; D005387:Finland; D005602:France; D000073656:Healthy Aging; D006801:Humans; D020407:Internet / Q000706:statistics & numerical data; D008019:Life Style; D008297:Male; D009426:Netherlands; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D000073278:Self-Management
CARDIOLOGY; EHEALTH; NEUROLOGY; PREVENTIVE MEDICINE; PUBLIC HEALTH