The PreCardio-study protocol – a randomized clinical trial of a multidisciplinary electronic cardiovascular prevention programme

In a randomized controlled trial, one group will receive a maximal intervention (= intervention group). The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team (psychologist, physiotherapist and dietician). The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback.This trial incorporates interventions by GPs and other health professionals aiming at a reduction of medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed.ISRCTN23940498In Europe, cardiovascular disease (CVD) is the leading cause of death (1.5 million deaths per year) and is an important source of disability [1-3]. The incidence of coronary vascular events is 1.91 per 1000 population years [4]. It is proven that prevention of CVD risk factors lead to a reduction of CVD[5,6]. Prevention programmes should include interventions aimed at a reduction of medical risk factors (hypertension, hypercholesterolaemia, hyperglycae