دورية أكاديمية
Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention.
| العنوان: | Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention. |
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| المؤلفون: | Baldassarre D; Centro Cardiologico Monzino IRCCS, Milan, Italy damiano.baldassarre@cardiologicomonzino.it.; Department of Medical Biotechnology and Translational Medicine, Università degli Studi di Milano, Milan, Italy., Iacoviello L; Department of Epidemiology and Prevention, IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy.; Research Center in Epidemiology and Preventive Medicine (EPIMED), Varese, Italy., Baetta R; Centro Cardiologico Monzino IRCCS, Milan, Italy., Roncaglioni MC; Laboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Condorelli G; Department of Cardiovascular Medicine, IRCCS-Humanitas Research Hospital, Rozzano, Italy.; Department of Biomedical Sciences, Humanitas University, Milan, Italy., Remuzzi G; Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Gensini G; IRCCS Multimedica, Milan, Italy., Frati L; IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy., Ricciardi W; Istituti Clinici Scientifici Maugeri IRCCS Pavia, Pavia, Italy.; Università Cattolica del Sacro Cuore - Campus di Roma, Rome, Italy., Conaldi PG; IRCCS ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), Palermo, Italy., Uccelli A; IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Blandini F; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Bosari S; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Scambia G; Università Cattolica del Sacro Cuore - Campus di Roma, Rome, Italy.; Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy., Fini M; IRCCS San Raffaele, Rome, Italy., Di Malta A; Co.S. (Consorzio Sanità) Study Center, Italy, Soresina, Italy., Amato M; Centro Cardiologico Monzino IRCCS, Milan, Italy., Veglia F; Maria Cecilia Hospital, GVM Care & Research, Cotignola, Ravenna, Italy., Bonomi A; Centro Cardiologico Monzino IRCCS, Milan, Italy., Klersy C; Unit of Clinical Epidemiology & Biostatistic, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Colazzo F; Centro Cardiologico Monzino IRCCS, Milan, Italy., Pengo M; Istituto Auxologico Italiano IRCCS, Milan, Italy.; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Gorini F; Istituto Auxologico Italiano IRCCS, Milan, Italy., Auteri L; Istituto Auxologico Italiano IRCCS, Milan, Italy., Ferrante G; Department of Cardiovascular Medicine, IRCCS-Humanitas Research Hospital, Rozzano, Italy.; Department of Biomedical Sciences, Humanitas University, Milan, Italy., Baviera M; Laboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Ambrosio G; Cardiology, University of Perugia School of Medicine, Perugia, Italy., Catapano A; IRCCS Multimedica, Milan, Italy.; Department of Pharmacological and Biomolecular Sciences, Università degli Studi di Milano, Milan, Italy., Gialluisi A; Department of Epidemiology and Prevention, IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy.; Research Center in Epidemiology and Preventive Medicine (EPIMED), Varese, Italy., Malavazos AE; Endocrinology Unit, Clinical Nutrition and Cardiovascular Prevention Service, IRCCS Policlinico San Donato, San Donato Milanese, Italy.; Department of Biomedical Surgical and Dental Sciences, Università degli Studi di Milano, Milan, Italy., Castelvecchio S; Department of Cardiac Surgery, IRCCS Policlinico San Donato, San Donato Milanese, Italy., Corsi-Romanelli MM; UOC SMEL-1, IRCCS POLICLINICO SAN DONATO, San Donato Milanese, Italy.; Department of Health and Biomedical Sciences, Università degli Studi di Milano, Milan, Italy., Cardani R; BioCor Biobank, UOC SMEL-1 of Clinical Pathology, IRCCS-Policlinico San Donato, San Donato Milanese, Italy., La Rovere MT; Istituti Clinici Scientifici Maugeri IRCCS Montescano, Montescano, Italy., Agnese V; IRCCS ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), Palermo, Italy., Pane B; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.; Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, Università degli Studi di Genova, Genoa, Italy., Prati D; Department of Transfusion Medicine and Haematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Spinardi L; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Liuzzo G; Università Cattolica del Sacro Cuore - Campus di Roma, Rome, Italy.; Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Gemelli IRCCS, Rome, Italy., Arbustini E; Centro Malattie Genetiche Cardiovascolari - Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Volterrani M; Cardio Pulmonary Department, IRCCS San Raffaele, Rome, Italy.; Exercise Science and Medicine, San Raffaele Open University, Rome, Italy., Visconti M; Co.S. (Consorzio Sanità) Study Center, Italy, Soresina, Italy., Werba JP; Centro Cardiologico Monzino IRCCS, Milan, Italy., Genovese S; Centro Cardiologico Monzino IRCCS, Milan, Italy., Bilo G; Istituto Auxologico Italiano IRCCS, Milan, Italy.; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Invitti C; Istituto Auxologico Italiano IRCCS, Milan, Italy., Di Blasio A; Istituto Auxologico Italiano IRCCS, Milan, Italy., Lombardi C; Istituto Auxologico Italiano IRCCS, Milan, Italy.; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Faini A; Istituto Auxologico Italiano IRCCS, Milan, Italy.; Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milan, Italy., Rosa D; Istituto Auxologico Italiano IRCCS, Milan, Italy., Ojeda-Fernández L; Laboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Foresta A; Laboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., De Curtis A; Department of Epidemiology and Prevention, IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy., Di Castelnuovo A; Mediterranea Cardiocentro, Naples, Italy., Scalvini S; Istituti Clinici Scientifici Maugeri IRCCS Lumezzane, Lumezzane, Italy., Pierobon A; Istituti Clinici Scientifici Maugeri IRCCS Montescano, Montescano, Italy., Gorini A; Istituti Clinici Scientifici Maugeri IRCCS Milano, Milan, Italy.; Dipartimento di Scienze Cliniche e di Comunità, Università degli Studi di Milano, Milan, Italy., Valenti L; Department of Transfusion Medicine and Haematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.; Dipartimento Fisiopatologia e Trapianti, Università degli Studi di Milano, Milan, Italy., Luzi L; IRCCS Multimedica, Milan, Italy.; Department of Health and Biomedical Sciences, Università degli Studi di Milano, Milan, Italy., Racca A; Federfarma Lombardia & Fondazione Guido Muralti, Milan, Italy., Bandi M; Federfarma Lombardia & Fondazione Guido Muralti, Milan, Italy., Tremoli E; Maria Cecilia Hospital, GVM Care & Research, Cotignola, Ravenna, Italy., Menicanti L; Department of Cardiac Surgery, IRCCS Policlinico San Donato, San Donato Milanese, Italy., Parati G; Istituto Auxologico Italiano IRCCS, Milan, Italy.; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Pompilio G; Centro Cardiologico Monzino IRCCS, Milan, Italy.; Department of Biomedical Surgical and Dental Sciences, Università degli Studi di Milano, Milan, Italy. |
| مؤلفون مشاركون: | CV-PREVITAL Study Group |
| المصدر: | BMJ open [BMJ Open] 2023 Jul 14; Vol. 13 (7), pp. e072040. Date of Electronic Publication: 2023 Jul 14. |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Cardiovascular Diseases*/prevention & control, Humans ; Prospective Studies ; Diet ; Exercise |
| مستخلص: | 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. Competing Interests: Competing interests: Authors and collaborators disclosed the relationships/activities/interests reported below. Grants or contracts from any entity: GSc, ACa, DPr, PW, ADiC, LV, LB, FCler, APa, LGM; Consulting fees: GSc, GL, SG, LV, LL, LGM, SL, IP; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: GSc, GA, ACa, DPr, GL, PW, SG, LV, LL, GPa, LB, LGi, EP, PA; Support for attending meetings and/or travel: DPr, LV, LL, EP, PA; Patents planned, issued or pending: LL, CGae; Participation on a Data Safety Monitoring Board or Advisory Board: GA, DPr, SG, LV, LL, LB, PA; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: GA, LV; Receipt of equipment, materials, drugs, medical writing, gifts or other services: LB, PA. Details are available in the individual ICMJE online disclosure forms (available upon request). (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| References: | Circulation. 2008 Feb 12;117(6):743-53. (PMID: 18212285) Psychiatry Res. 1989 May;28(2):193-213. (PMID: 2748771) Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. (PMID: 24622367) Ann Ist Super Sanita. 2004;40(4):393-9. (PMID: 15815105) J Health Soc Behav. 1983 Dec;24(4):385-96. (PMID: 6668417) J Biomed Inform. 2017 Jul;71:31-48. (PMID: 28536062) Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957) Nutr Metab Cardiovasc Dis. 2020 Mar 9;30(3):426-433. (PMID: 31791640) J Biomed Inform. 2009 Apr;42(2):377-81. (PMID: 18929686) Arch Intern Med. 2007 May 28;167(10):1068-74. (PMID: 17533210) Psychosomatics. 2009 Nov-Dec;50(6):613-21. (PMID: 19996233) Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. (PMID: 24222018) J Nutr. 2011 Jun;141(6):1140-5. (PMID: 21508208) Eur Heart J. 2003 Jun;24(11):987-1003. (PMID: 12788299) Nat Rev Cardiol. 2021 Jul;18(7):457-458. (PMID: 33824486) Monaldi Arch Chest Dis. 2007 Sep;68(3):178-83. (PMID: 18361215) Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:517-520. (PMID: 28324932) Eur Heart J. 2010 Mar;31(5):614-22. (PMID: 19952003) J Hypertens. 2018 Mar;36(3):472-478. (PMID: 29384983) Eur J Prev Cardiol. 2012 Aug;19(4):723-30. (PMID: 21571772) Circulation. 2020 Mar 3;141(9):e139-e596. (PMID: 31992061) Lancet Diabetes Endocrinol. 2019 Sep;7(9):715-725. (PMID: 31301983) Eur J Clin Nutr. 2019 May;73(5):793-800. (PMID: 30089793) J Biomed Inform. 2019 Jul;95:103208. (PMID: 31078660) Ann Intern Med. 2008 Jan 15;148(2):102-10. (PMID: 18195335) PLoS One. 2012;7(8):e43134. (PMID: 22905215) Mayo Clin Proc. 2015 Apr;90(4):469-80. (PMID: 25841251) |
| فهرسة مساهمة: | Investigator: G Pompilio; D Baldassarre; R Baetta; M Amato; JP Werba; S Genovese; G Colombo; C Vavassori; ML Biondi; B Frigerio; A Ravani; D Sansaro; D Coggi; A Romandini; M Giroli; M Giuliani; A Bonomi; M Rondinelli; C Trudu; C Cinieri; M Monturano; F Colazzo; G Parati; C Invitti; G Bilo; M Pengo; F Gorini; L Auteri; A Faini; C Lombardi; AD Blasio; D Rosa; C Torlasco; L Gilardini; D Soranna; A Zambon; E Perger; L Zanotti; L Badano; L Cova; D Gentilini; L Grappiolo; G Condorelli; G Ferrante; L Papa; V Savevski; F Ieva; I Romano; G Remuzzi; MC Roncaglioni; M Baviera; L Ojeda; A Foresta; F Clerici; A Palumbo; GF Gensini; G Ambrosio; A Catapano; R Mattioli; E Longhi; L Luzi; LG Mantovani; F Madotto; L Frati; L Iacoviello; AD Castelnuovo; A Gialluisi; A Curtis; M Bonaccio; F Gianfagna; A Ghulam; S Magnacca; F Noro; S Costanzo; S Esposito; S Orlandi; M Persichillo; F Bracone; T Panzera; E Ruggiero; R Parisi; S Franciosa; M Morelli; F Rita; C Cerletti; G Gaetano; MB Donati; L Menicanti; S Castelvecchio; AE Malavazos; MM Romanelli; R Cardani; A Cerri; C Dubini; MB Trevisan; LV Renna; V Milani; S Boveri; P Giubbilini; L Ramputi; I Baroni; G DeAngeli; W Ricciardi; MT La Rovere; S Scalvini; A Pierobon; A Gorini; F Olmetti; M Bussotti; C Gaetano; P Baiardi; T Bachetti; M Balbi; L Comini; M Lorenzoni; A Olivares; E Traversi; C Garrè; R Sideri; PG Conaldi; V Agnese; F Clemenza; G Gentile; G Caruana; N Cuscino; GD Gesaro; A Greco; I Loddo; F Tuzzolino; A Uccelli; B Pane; D Palombo; G Spinella; G Mozzetta; P Ameri; G Zoppoli; A Finotello; I Porto; G Pratesi; F Blandini; D Prati; L Valenti; L Spinardi; M Clerici; S Pelusi; C Bianco; R Carpani; G Periti; S Margarita; G Scambia; G Liuzzo; GA Lanza; A Severino; D Pedicino; D D'Amario; A D'Aiello; R Vinci; A Bonanni; M Brecciaroli; S Filomia; R Pastorino; S Boccia; A Urbani; M Sanguinetti; A Santoliquido; L Proto; D Tarquini; MC Grimaldi; E Arbustini; C Klersy; S Leonardi; A Elia; A Currao; M Urtis; AD Toro; L Giuliani; M Fini; M Volterrani; G Caminiti; F Marcolongo; B Sposato; F Guadagni; V Morsella; A Marziale; AD Malta; M Visconti; A Racca; M Bandi; G Protti Keywords: Cardiac Epidemiology; Clinical trials; Health informatics; PREVENTIVE MEDICINE |
| سلسلة جزيئية: | ClinicalTrials.gov NCT05339841 |
| تواريخ الأحداث: | Date Created: 20230714 Date Completed: 20230717 Latest Revision: 20231124 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC10351259 |
| DOI: | 10.1136/bmjopen-2023-072040 |
| PMID: | 37451717 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2023-072040 |