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

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2024年9月13日

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Alberto Pilotto,
Marina Barbagelata,
Eleonora Lacorte,
Carlo Custodero,
Nicola Veronese,
Valentina Maione,
Wanda Morganti,
Emanuele Seminerio,
Paola Piscopo,
Elisa Fabrizi,
Patrizia Lorenzini,
Elena Carbone,
Pierangelo Lora Aprile,
Vincenzo Solfrizzi,
Mario Barbagallo,
Nicola Vanacore,
Maddalena Pettenati,
Alberto Ferri,
Cesare Massone,
Alessandra Argusti,
Simone Canepa,
Massimiliano Gresonti,
Marco De Benedetto,
Carlo Berutti-Bergotto,
Antonio Mazzocca,
Rosa Rita Paparella,
Dragana Nikolic,
Sharon Di Vendra,
Roberto Rivabene,
Alessio Crestini,
Paola Fortini,
Lucia Conti,
Francesco Della Gatta

摘要

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.