Italian Digital Primary Cardiovascular Prevention Study

Summary

The CV-PREVITAL study is a randomised clinical trial (RCT) controlled versus usual-care designed to compare the effectiveness of a mobile health (mHealth) intervention with that of usual care in reducing specific cardiovascular (CV) risk factors (in the short term) and the occurrence of vascular events (in the long term). Promoted by the Italian Network of Cardiology (ICN, a cardiovascular research network promoted by the Italian Ministry of Health), in collaboration with the Consorzio Sanità (Co.S., an Italian consortium of general practitioners), CV-PREVITAL aims to develop an innovative model of cardiovascular primary prevention and to validate it in a very large sample of subjects and in 'real life' conditions.

Conditions

• Healthy Population

Interventions

OTHER

Mobile health application

The mHealth app delivers a personalized support program of digital health. Specifically, using ad hoc designed algorithms which uses the data self-reported by the subject and/or collected by the recruiter at baseline, the App delivers periodic messages with advice, motivational reminders and support to improve lifestyle habits and risk factor control.

Sponsors & Collaborators

• Istituto Auxologico Italiano

  collaborator OTHER

• Humanitas Hospital, Italy

  collaborator OTHER

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• IRCCS Multimedica

  collaborator OTHER

• Neuromed IRCCS

  collaborator OTHER

• IRCCS Policlinico S. Donato

  collaborator OTHER

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• IRCCS San Raffaele Roma

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Centro Cardiologico Monzino

  lead OTHER

Principal Investigators

• Giulio Pompilio, Professor · Centro Cardiologico Monzino IRCCS

• Gianfranco Parati, Professor · Istituto Auxologico Italiano IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-10

Primary Completion

2029-06-30

Completion

2029-12-31

Countries

• Italy

Study Locations