Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation
Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation
The goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases (CVD) in the population. The main questions it aims to answer are:
Participants will be randomized in one of the four parallel arms:
The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline, alone or in combination with the use of a wearable device, on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline, nor respect to subjects receiving traditional risk assessment plus adopting wearable devices.
The trial will consist of four phases: an enrollment phase (T0), a disclosure visit three weeks later (T1), a follow-up visit five months after the disclosure visit (T2), and a final follow-up twelve months from enrollment (T3).
Once enrolled (T0), all participants will sign the informed consent form and undergo a comprehensive assessment, which includes:
At T1, a disclosure visit will be conducted to explain the assigned lifestyle category, share the results of the blood tests, and provide information on the expected interventions based on the assigned group.
The questionnaire will be administered at T0, T2, and T3. Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3
Inclusion Criteria:
Exclusion Criteria:
stefania.boccia@policlinicogemelli.it+390630154396