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,
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,
PrimaCare_P3 study group
Affiliations
Alberto Pilotto
Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, E.O. Galliera Hospital
Marina Barbagelata
Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, E.O. Galliera Hospital
Eleonora Lacorte
National Center for Disease Prevention and Health Promotion, Italian National Institute of Health
Carlo Custodero
Department of Interdisciplinary Medicine, University of Bari “Aldo Moro”
Nicola Veronese
Geriatrics Unit, Department of Internal Medicine and Geriatrics, University of Palermo
Valentina Maione
Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, E.O. Galliera Hospital
Wanda Morganti
Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, E.O. Galliera Hospital
Emanuele Seminerio
Geriatrics Unit, Department of Geriatric Care, Neurology and Rehabilitation, E.O. Galliera Hospital
Paola Piscopo
Department of Neuroscience, Italian National Institute of Health
Elisa Fabrizi
National Center for Disease Prevention and Health Promotion, Italian National Institute of Health
Patrizia Lorenzini
National Center for Disease Prevention and Health Promotion, Italian National Institute of Health
Elena Carbone
Department of Interdisciplinary Medicine, University of Bari “Aldo Moro”
Pierangelo Lora Aprile
Italian College of General Practitioners and Primary Care
Vincenzo Solfrizzi
Department of Interdisciplinary Medicine, University of Bari “Aldo Moro”
Mario Barbagallo
Geriatrics Unit, Department of Internal Medicine and Geriatrics, University of Palermo
Nicola Vanacore
National Center for Disease Prevention and Health Promotion, Italian National Institute of Health
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.
