| Autor: |
Roberta Pastorino, Angelo Maria Pezzullo, Antonella Agodi, Chiara de Waure, Walter Mazzucco, Luigi Russo, Martina Bianchi, Alessandra Maio, Sara Farina, Martina Porcelli, Diego Maria Tona, Matteo Di Pumpo, Rosarita Amore, Malgorzata Wachocka, Tina Pasciuto, Martina Barchitta, Roberta Magnano San Lio, Giuliana Favara, Antonino Tuttolomondo, Fabio Tramuto, Gaia Morello, Daniele Domenico De Bella, Santo Fruscione, Anna Severino, Giovanna Liuzzo, Stefania Boccia |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
Frontiers in Public Health, Vol 12 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2296-2565 |
| DOI: |
10.3389/fpubh.2024.1335894 |
| Popis: |
BackgroundCardiovascular diseases (CVDs) pose a significant global health challenge, necessitating innovative approaches for primary prevention. Personalized prevention, based on genetic risk scores (PRS) and digital technologies, holds promise in revolutionizing CVD preventive strategies. However, the clinical efficacy of these interventions requires further investigation. This study presents the protocol of the INNOPREV randomized controlled trial, aiming to evaluate the clinical efficacy of PRS and digital technologies in personalized cardiovascular disease prevention.MethodsThe INNOPREV trial is a four-arm RCT conducted in Italy. A total of 1,020 participants, aged 40–69 with high 10-year CVD risk based on SCORE 2 charts, will be randomly assigned to traditional CVD risk assessment, genetic testing (CVD PRS), digital intervention (app and smart band), or a combination of genetic testing and digital intervention. The primary objective is to evaluate the efficacy of providing CVD PRS information, measured at baseline, either alone or in combination with the use of an app and a smart band, on two endpoints: changes in lifestyle patterns, and modification in CVD risk profiles. Participants will undergo a comprehensive assessment and cardiovascular evaluation at baseline, with follow-up visits at one, five, and 12 months. Lifestyle changes and CVD risk profiles will be assessed at different time points beyond the initial assessment, using the Life's Essential 8 and SCORE 2, respectively. Blood samples will be collected at baseline and at study completion to evaluate changes in lipid profiles. The analysis will employ adjusted mixed-effect models for repeated measures to assess significant differences in the data collected over time. Additionally, potential moderators and mediators will be examined to understand the underlying mechanisms of behavior change.DiscussionAs the largest trial in this context, the INNOPREV trial will contribute to the advancement of personalized cardiovascular disease prevention, with the potential to positively impact public health and reduce the burden of CVDs on healthcare systems. By systematically examining the clinical efficacy of PRS and digital interventions, this trial aims to provide valuable evidence to guide future preventive strategies and enhance population health outcomes. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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