Abstract

Background

Multicomponent interventions based on a comprehensive geriatric assessment (CGA) could promote active aging and improve health status in older people with Noncommunicable Chronic Diseases (NCDs), but conflicting evidences are available.

Aim

To evaluate the efficacy of a CGA-based multicomponent personalized preventive program (PPP) in reducing unplanned hospitalization rates during 12-month follow-up in community-dwelling older people with NCDs.

Materials and methods

In this randomized clinical trial (RCT), 1216 older adults recruited by 33 general practitioners (GPs) will be randomly allocated to intervention group (IG) or usual care control group (CG). The IG will receive a multicomponent PPP developed on the findings of the CGA-based Multidimensional Prognostic Index short-form (Brief-MPI), including structured interventions to improve functional, physical, cognitive, and nutritional status, to monitor NCDs and vaccinations, and to prevent social isolation. Participants in the CG will receive usual care. Brief-MPI, resilience, and health-related quality of life will be assessed after 6 and 12 months. Moreover, saliva samples will be collected at baseline in IG to measure biomarkers of oxidative stress, inflammatory cytokines, and oral microbiome.

Expected results

The CGA-based PPP might reduce unplanned hospitalization rates and potentially institutionalization rates, emergency department (ED) and unplanned GP visits, and mortality. Further outcomes explored in the IG will be the adherence to PPP, resilience, health-related quality of life, and multidimensional frailty as assessed by the Brief-MPI.

Conclusions

Results will suggest whether the CGA-based multicomponent PPP is able to improve specific outcomes in a primary care setting.

Trial registration

ClinicalTrials.gov; identifier: NCT06224556; Registered January 25, 2024.

Details

Title
A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study)
Author
Pilotto, Alberto 1 ; Barbagelata, Marina 2   VIAFID ORCID Logo  ; Lacorte, Eleonora 3 ; Custodero, Carlo 4 ; Veronese, Nicola 5 ; Maione, Valentina 2 ; Morganti, Wanda 2 ; Seminerio, Emanuele 2 ; Piscopo, Paola 6 ; Fabrizi, Elisa 3 ; Lorenzini, Patrizia 3 ; Carbone, Elena 7 ; Lora Aprile, Pierangelo 8 ; Solfrizzi, Vincenzo 4 ; Barbagallo, Mario 5 ; Vanacore, Nicola 3 ; Pettenati, Maddalena; Ferri, Alberto; Massone, Cesare; Argusti, Alessandra; Canepa, Simone; Gresonti, Massimiliano; De Benedetto, Marco; Berutti-Bergotto, Carlo; Mazzocca, Antonio; Paparella, Rosa Rita; Nikolic, Dragana; Di Vendra, Sharon; Rivabene, Roberto; Crestini, Alessio; Fortini, Paola; Conti, Lucia; Della Gatta, Francesco

1  E.O. Galliera Hospital, Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, Genoa, Italy (GRID:grid.450697.9) (ISNI:0000 0004 1757 8650); University of Bari “Aldo Moro”, Department of Interdisciplinary Medicine, Bari, Italy (GRID:grid.7644.1) (ISNI:0000 0001 0120 3326) 
2  E.O. Galliera Hospital, Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, Genoa, Italy (GRID:grid.450697.9) (ISNI:0000 0004 1757 8650) 
3  Italian National Institute of Health, National Center for Disease Prevention and Health Promotion, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
4  University of Bari “Aldo Moro”, Department of Interdisciplinary Medicine, Bari, Italy (GRID:grid.7644.1) (ISNI:0000 0001 0120 3326) 
5  University of Palermo, Geriatrics Unit, Department of Internal Medicine and Geriatrics, Palermo, Italy (GRID:grid.10776.37) (ISNI:0000 0004 1762 5517) 
6  Italian National Institute of Health, Department of Neuroscience, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
7  University of Bari “Aldo Moro”, Department of Interdisciplinary Medicine, Bari, Italy (GRID:grid.7644.1) (ISNI:0000 0001 0120 3326); Italian National Institute of Health, Department of Neuroscience, Rome, Italy (GRID:grid.416651.1) (ISNI:0000 0000 9120 6856) 
8  Italian College of General Practitioners and Primary Care, Florence, Italy (GRID:grid.416651.1) 
Pages
611
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-024-08413-1
ProQuest document ID
3104294693
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.