BMJ Open (Jul 2023)

Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention

  • ,
  • Roberta Pastorino,
  • Eloisa Arbustini,
  • Andrea Faini,
  • Gianfranco Parati,
  • Grzegorz Bilo,
  • Davide Soranna,
  • Antonella Zambon,
  • Sergio Leonardi,
  • Alessandro Gialluisi,
  • Lorenzo Giovanni Mantovani,
  • Walter Ricciardi,
  • Fabio Blandini,
  • Giovanni Scambia,
  • Catherine Klersy,
  • Marialaura Bonaccio,
  • Augusto Di Castelnuovo,
  • Simona Costanzo,
  • Amalia De Curtis,
  • Mariarosaria Persichillo,
  • Chiara Cerletti,
  • Maria Benedetta Donati,
  • Licia Iacoviello,
  • Giuseppe Remuzzi,
  • Camilla Torlasco,
  • Giuseppe Ambrosio,
  • Gabriele Zoppoli,
  • Maria Chiara Grimaldi,
  • Daniela Pedicino,
  • Giovanna Liuzzo,
  • Serena Pelusi,
  • Daniele Prati,
  • Luca Valenti,
  • Francesca Gorini,
  • Maurizio Sanguinetti,
  • Giuseppe Ferrante,
  • Gianluigi Condorelli,
  • Giulio Pompilio,
  • Stefania Boccia,
  • Luigi Badano,
  • Victor Savevski,
  • Tiziana Bachetti,
  • Gian Franco Gensini,
  • Silvano Bosari,
  • Alice Bonanni,
  • Elena Tremoli,
  • Angelo Santoliquido,
  • Stefano Genovese,
  • Sara Boveri,
  • Gianfranco Gensini,
  • Francesco Gianfagna,
  • Italo Porto,
  • Fabio Tuzzolino,
  • Carolina Lombardi,
  • Egidio Traversi,
  • Fabrizio Veglia,
  • Andrea Urbani,
  • Domenico D’Amario,
  • Gaetano Antonio Lanza,
  • Antonio Uccelli,
  • José Pablo Werba,
  • Livio Luzi,
  • Pietro Ameri,
  • Davide Gentilini,
  • Luisa Gilardini,
  • Cecilia Invitti,
  • Maurizio Volterrani,
  • Maria Teresa La Rovere,
  • Giovanni Gentile,
  • Francesco Clemenza,
  • Mario Urtis,
  • Francesca Ieva,
  • Maria Carla Roncaglioni,
  • Valentina Milani,
  • Paola Baiardi,
  • Debora Rosa,
  • Fabiana Madotto,
  • Emilia Ruggiero,
  • Teresa Panzera,
  • Simona Esposito,
  • Sara Magnacca,
  • Fabrizia Noro,
  • Roberta Parisi,
  • Francesca Bracone,
  • Irene Baroni,
  • Damiano Baldassarre,
  • Roberta Baetta,
  • Luigi Frati,
  • Pier Giulio Conaldi,
  • Massimo Fini,
  • Antonio Di Malta,
  • Mauro Amato,
  • Alice Bonomi,
  • Francesca Colazzo,
  • Martino Pengo,
  • Luciana Auteri,
  • Marta Baviera,
  • Alberico Catapano,
  • Alexis Elias Malavazos,
  • Serenella Castelvecchio,
  • Massimiliano Marco Corsi-Romanelli,
  • Rosanna Cardani,
  • Valentina Agnese,
  • Bianca Pane,
  • Laura Spinardi,
  • Marco Visconti,
  • Anna Di Blasio,
  • Luisa Ojeda-Fernández,
  • Andreana Foresta,
  • Simonetta Scalvini,
  • Antonia Pierobon,
  • Alessandra Gorini,
  • Annarosa Racca,
  • Manuela Bandi,
  • Lorenzo Menicanti,
  • Gualtiero Colombo,
  • Chiara Vavassori,
  • Maria Luisa Biondi,
  • Beatrice Frigerio,
  • Alessio Ravani,
  • Daniela Sansaro,
  • Daniela Coggi,
  • Alessandra Romandini,
  • Monica Giroli,
  • Mattia Giuliani,
  • Maurizio Rondinelli,
  • Catia Trudu,
  • Carmen Cinieri,
  • Massimo Monturano,
  • Anna Di Blasio,
  • Elisa Perger,
  • Lucia Zanotti,
  • Lidia Cova,
  • Luca Grappiolo,
  • Laura Papa,
  • Ignazio Romano,
  • Luisa Ojeda,
  • Fiorenza Clerici,
  • Angela Palumbo,
  • Roberto Mattioli,
  • Ermanno Longhi,
  • Augusto Di Castelnuovo,
  • Amalia De Curtis,
  • Anwal Ghulam,
  • Sabatino Orlandi,
  • Sabrina Franciosa,
  • Martina Morelli,
  • Fiorella De Rita,
  • Giovanni de Gaetano,
  • Massimiliano MarcoCorsi Romanelli,
  • Ambra Cerri,
  • Carola Dubini,
  • Manuel Bruno Trevisan,
  • Laura Valentina Renna,
  • Paola Giubbilini,
  • Lucia Ramputi,
  • Giada DeAngeli,
  • Francesca Olmetti,
  • Maurizio Bussotti,
  • Carlo Gaetano,
  • Martina Balbi,
  • Laura Comini,
  • Monica Lorenzoni,
  • Adriana Olivares,
  • Camilla Garrè,
  • Riccardo Sideri,
  • Giuseppe Caruana,
  • Nicola Cuscino,
  • Gabriele Di Gesaro,
  • Alessio Greco,
  • Italia Loddo,
  • Domenico Palombo,
  • Giovanni Spinella,
  • Gaddiel Mozzetta,
  • Alice Finotello,
  • Giovanni Pratesi,
  • Margherita Clerici,
  • Cristiana Bianco,
  • Rossana Carpani,
  • Giulia Periti,
  • Sara Margarita,
  • Anna Severino,
  • Alessia D’Aiello,
  • Ramona Vinci,
  • Mattia Brecciaroli,
  • Simone Filomia,
  • Luca Proto,
  • Dalila Tarquini,
  • Arianna Elia,
  • Alessia Currao,
  • Alessandro Di Toro,
  • Lorenzo Giuliani,
  • Giuseppe Caminiti,
  • Federica Marcolongo,
  • Barbara Sposato,
  • Fiorella Guadagni,
  • Valentina Morsella,
  • Angelica Marziale,
  • Antonio Di Malta,
  • Giulia Protti

DOI
https://doi.org/10.1136/bmjopen-2023-072040
Journal volume & issue
Vol. 13, no. 7

Abstract

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Introduction Prevention 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 analysis The 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 dissemination This 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 number NCT05339841.