Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Sep 13;25(1):611.
doi: 10.1186/s13063-024-08413-1.

A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study)

Alberto Pilotto  1   2 , Marina Barbagelata  3 , Eleonora Lacorte  4 , Carlo Custodero  2 , Nicola Veronese  5 , Valentina Maione  1 , Wanda Morganti  1 , Emanuele Seminerio  1 , Paola Piscopo  6 , Elisa Fabrizi  4 , Patrizia Lorenzini  4 , Elena Carbone  2   6 , Pierangelo Lora Aprile  7 , Vincenzo Solfrizzi  2 , Mario Barbagallo  5 , Nicola Vanacore  4 ; PrimaCare_P3 study group
Collaborators, Affiliations

A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study)

Alberto Pilotto et al. Trials. .

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.

Keywords: Comprehensive geriatric assessment; Multicomponent interventions; Non-communicable chronic diseases; Older people; Personalized prevention program; Primary care setting.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
a Study design and inclusion criteria. b Timeline of the PrimaCare_P3 project related to the Intervention Group and the Control Group. Abbreviations: Brief-MPI, Brief- Multidimensional Prognostic Index; RS-14, Resilience Scale—14 Items; PGWB-S, Psychological General Wellbeing index—Short version; CSQ-8, Client Satisfaction Questionnaire—8 items; GP, General Practitioner
Fig. 2
Fig. 2
SPIRIT figure. Schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

References

    1. World Health Organization. Title of subordinate document. In: Noncommunicable diseases progress monitor 2022. https://www.who.int/publications/i/item/9789240047761. Accessed 14 Feb 2023.
    1. Contoli B, Possenti V, Gallo R, Minardi V, Masocco M. Data from the PASSI d’Argento Surveillance System on difficulties met by older adults in accessing health services in Italy as major risk factor to health outcomes. Int J Environ Res Public Health. 2022;19(16):10340. 10.3390/ijerph191610340. Published 2022 Aug 19. 10.3390/ijerph191610340 - DOI - PMC - PubMed
    1. Ferrucci L, Fabbri E. Inflammageing: chronic inflammation in ageing, cardiovascular disease, and frailty. Nat Rev Cardiol. 2018;15(9):505–22. 10.1038/s41569-018-0064-2. 10.1038/s41569-018-0064-2 - DOI - PMC - PubMed
    1. Zampino M, Polidori MC, Ferrucci L, et al. Biomarkers of aging in real life: three questions on aging and the comprehensive geriatric assessment. Geroscience. 2022;44(6):2611–22. 10.1007/s11357-022-00613-4. 10.1007/s11357-022-00613-4 - DOI - PMC - PubMed
    1. Veronese N, Custodero C, Demurtas J, et al. Comprehensive geriatric assessment in older people: an umbrella review of health outcomes. Age Ageing. 2022;51(5):afac104. 10.1093/ageing/afac104. 10.1093/ageing/afac104 - DOI - PubMed

Publication types

Associated data

LinkOut - more resources