A Personalized Prevention Program (PPP) Based on the Comprehensive Geriatric Assessment (CGA) for the Prevention of Multidimensional Frailty Related to Non-communicable Chronic Diseases (NCDs) in Older People

NCT06224556 | Recruiting

• 1 other identifier: PNRR-MAD-2022-12376781
• Study Type: interventional
• Target: 1,216
• Locations: 1 country
• Sites: 4

Brief Summary

• Non-Communicable Diseases (NCDs) can accelerated the aging process and increase the frailty condition
• The Comprehensive Geriatric Assessment (CGA) is the gold standard in the geriatric clinical context
• Recently, in Italy the first Guidelines about the CGA in different settings for older people has been pubblicated
• The CGA can identify older people at high risk of frailty who can benefit from a personalized prevention program
• No studies has been investigated the effects of a personalized prevention program (PPP) based on the CGA in a primary care setting
• The main hypothesis is that the CGA assessment can result in personalized prevention programs for older subjects in primary care settings with an effect in reducing the hospitalization rate and can be related to the biological paramters in NCDs

Conditions

Older People; Non-Communicable Chronic Diseases

Keywords

Primary care setting; Comprehensive Geriatric Assessment; Older people; Non-communicable chronic diseases; Personalized Prevention Program; Saliva collection

Outcome Measures

Primary Outcomes (1)

• Hospitalization rate

  Unplanned hospitalization rate

  12 months

Secondary Outcomes (3)

• Composed outcome

  6 and 12 months

• Number of unplanned General Practitioners visits

  12 months

• Mortality rate

  6 and 12 months

Other Outcomes (11)

• Adherence at the PPP

  6 and 12 months

• Psychological Well-being

  Baseline, 6 and 12 months

• Resilience

  Baseline, 6 and 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

All the 608 patients will be evaluated by their General Practitioners through the Brief-MPI scale, which is based on the Comprehensive Geriatric Assessment (CGA). Based on the score obtained at the Brief-MPI, the patient will receive a Personalised Prevention Program (PPP) concerning the following domains: 1) motor, 2) cognitive, 3) nutritional, 4) polypharmacotherapy, 5) vaccination prevention, 6) basal and instrumental activities, 7) co-habitation. Patients will receive brochures containing practical advice and recommendations to be implemented over a 12-month period; in the case of high Brief-MPI risk scores, patients will be referred for specialist examinations and/or in-depth diagnostics. In addition, saliva samples will be collected to assess biomarkers of oxidative stress and, in a subsample of 210 subjects, the composition of the oral microbiota will also be analysed.

Combination Product: Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program

Control group

NO INTERVENTION

Patients will receive the standard clinical practice by their General Practitioners, without being evaluated by the CGA or receiving the personalized prevention program (PPP). No saliva sample will be collected.

Interventions

Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program COMBINATION_PRODUCT

Patients will be evaluated at baseline and at 6 and 12 months after the baseline through the CGA, the Resilience Scale (RS-14 items) and the Psychological General Wellbeing Index short form. The prevention program will be received at the baseline, so at the two follow-ups patients wiil asked the adherence to it and the level of satisfaction (Client Satisfaction Questionnaire - 8 items). Saliva sample will be collected and analyzed.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old and over
• At least 1 non-communicable chronic disease
• Signed informed consent

You may not qualify if:

• not willing in partecipating in the study and no signed informed consent
• \<65 years old
• without non-communicable chronic diseases

Sponsors & Collaborators

• Alberto Pilotto: lead

Study Sites (4)

Polimedica Societa' Cooperativa

Bari, Italy

RECRUITING

Medici Insieme Garda Valsabbia Societa' Cooperativa

Desenzano del Garda, Italy

RECRUITING

Ambulatori medici

Florence, Italy

RECRUITING

COMEGEN Società Cooperativa Sociale

Napoli, Italy

RECRUITING

Related Publications (2)

• Pilotto A, Morganti W, Seminerio E, Lacorte E, Custodero C, Veronese N, Fielding P, Massone C, Piscopo P, Fabrizi E, Lorenzini P, Magni A, Piccinocchi G, Ignazzi C, Busco L, Barbagallo M, Massone C, Aprile PL, Vanacore N. Usefulness of the BRIEF-Multidimensional Prognostic Index (BRIEF-MPI) to identify older adults' healthcare needs to be addressed with a Personalized Prevention Program in general practice: preliminary data from the PrimaCare_P3 study. BMC Prim Care. 2025 Oct 27;26(1):323. doi: 10.1186/s12875-025-02951-6.

  PMID: 41146026 DERIVED

• Pilotto A, Barbagelata M, Lacorte E, Custodero C, Veronese N, Maione V, Morganti W, Seminerio E, Piscopo P, Fabrizi E, Lorenzini P, Carbone E, Lora Aprile P, Solfrizzi V, Barbagallo M, Vanacore N; PrimaCare_P3 study group. A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study). Trials. 2024 Sep 13;25(1):611. doi: 10.1186/s13063-024-08413-1.

  PMID: 39272196 DERIVED

MeSH Terms

Conditions

Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Pilotto

  Director of the Department of Geriatric Care, orthogeroatric and rehabilitation, EO Galliera Hospital, Genova, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Pilotto

CONTACT

0039 0105634467; alberto.pilotto@galliera.it

Marina Barbagelata

CONTACT

marina.barbagelata@galliera.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The General Practitioners (GPs) involved will be randomised in clusters in a 1:1 ratio, therefore one group of GPs will enrol patients for the Intervention Group and a second group of GPs will include patients for the Control Group. Therefore, the role of GPs are masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Geriatric Care, Orthogeriatrics and Rehabilitation

Model Details: The Intervention Group will receive the Personlized Prevention Program (PPP) be evaluated by a Comprehensive Geriatric Assessment thanks to the Multidimensional Prognostic Index (MPI) questionnaire.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 25, 2024
• Study Start: June 4, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)