Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention
Authors: Baldassarre Damiano , Iacoviello Licia , Baetta Roberta , Roncaglioni Maria Carla , Condorelli Gianluigi , Remuzzi Giuseppe , Gensini Gianfranco , Frati Luigi , Ricciardi Walter , Conaldi Pier Giulio , Uccelli Antonio , Blandini Fabio , Bosari Silvano , Scambia Giovanni , Fini Massimo , Di Malta Antonio , Amato Mauro , Veglia Fabrizio , Bonomi Alice , Klersy Catherine , Colazzo Francesca , Pengo Martino , Gorini Francesca , Auteri Luciana , Ferrante Giuseppe , Baviera Marta , Ambrosio Giuseppe , Catapano Alberico , Gialluisi Alessandro , Malavazos Alexis Elias , Castelvecchio Serenella , Corsi-Romanelli Massimiliano Marco , Cardani Rosanna , Rovere Maria Teresa La , Agnese Valentina , Pane Bianca , Prati Daniele , Spinardi Laura , Liuzzo Giovanna , Arbustini Eloisa , Volterrani Maurizio , Visconti Marco , Werba José Pablo , Genovese Stefano , Bilo Grzegorz , Invitti Cecilia , Di Blasio Anna , Lombardi Carolina , Faini Andrea , Rosa Debora , Ojeda-Fernández Luisa , Foresta Andreana , De Curtis Amalia , Di Castelnuovo Augusto , Scalvini Simonetta , Pierobon Antonia , Gorini Alessandra , Valenti Luca , Luzi Livio , Racca Annarosa , Bandi Manuela , Tremoli Elena , Menicanti Lorenzo , Parati Gianfranco , Pompilio Giulio 
Published: July 2023

IntroductionPrevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking.Methods and analysisThe CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners’ offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed.Ethics and disseminationThis study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study’s course and findings through regular meetings.Trial registration numberNCT05339841.