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 (PrimaCare_P3)

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: a Practical Approach in Primary Care Setting

• 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

Study Overview

• Status: Recruiting
• Conditions: Older People; Non-Communicable Chronic Diseases
• Intervention / Treatment: Combination product: Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program

Detailed Description

The main aim of the project is to evaluate in older people the effectiveness of personalized preventive interventions based on the Comprehensive Geriatric Assessment (CGA) in the primary care setting and to explore biological process in Non-Communicable Disases (NCDs).

The study involves 1216 subjects enrolled by General Practitioners (GPs) in four different Italian Areas.

The GPs involved will be randomised to 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.

The sample size:

A recent Cochrane systematic review reports a significant reduction in the risk of unplanned hospitalisation in community-dwelling elderly persons treated with VMD compared to standard clinical practice (RR= 0.83; CI 95%: 0.70-0.99). Thus, assuming an incidence of unplanned hospitalisations in one year of 38.8% in the group receiving PPP compared to 47.7% in the group randomised to standard care and assuming a power of 80% and a type I error of 5%, a total of 972 participants will be enrolled. Furthermore, assuming a drop-out rate of 20% over the 1-year follow-up period, the final sample will be 1216 participants, 608 in each group

608 subjects will be involved in the intervention group: they will receive the Personalized Prevention Program (PPP) and a saliva sample will be collected.

608 subjects will be involved in the control group according to the normal clinical practice.

Both groups will be contacted at 6 and 12 months after the baseline for the follow-up.

Statistical analyses:

Baseline characteristics will be compared between the group receiving the CGA-based PPP intervention and the control group. Continuous variables will be compared using the t-Student test and categorical variables using the Chi-square test. The cumulative probability of the primary and secondary outcome will be estimated by Kaplan-Meier curve, using the log-rank test to assess differences between the two groups. To assess the risk associated with the primary outcome (rate of unplanned hospitalisation at 12 months) in subjects in the intervention group compared to subjects in standard care, the Hazard Ratio (HR) will be estimated by fitting a Cox model, after testing for proportional hazards. Similarly, the risk of secondary outcomes will be estimated.

• Study Type: Interventional
• Enrollment (Estimated): 1216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Pilotto; Phone Number: 0039 0105634467; Email: alberto.pilotto@galliera.it
• Study Contact Backup: Name: Marina Barbagelata; Email: marina.barbagelata@galliera.it

Study Locations

• Italy
  • Bari, Italy
    • Recruiting
    • Polimedica Societa' Cooperativa
  • Desenzano Del Garda, Italy
    • Recruiting
    • Medici Insieme Garda Valsabbia Societa' Cooperativa
  • Firenze, Italy
    • Recruiting
    • Ambulatori medici
  • Napoli, Italy
    • Recruiting
    • COMEGEN Società Cooperativa Sociale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization rate	Unplanned hospitalization rate	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composed outcome	Composed outcome including: emergency access rate, hospitalization and institutionalization rates at 6 and 12 months after the baseline.	6 and 12 months
Number of unplanned General Practitioners visits	Unplanned GPs visits	12 months
Mortality rate	mortality rate at 6 and 12 months	6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence at the PPP	Adherence at the Personalized Prevention Program by the Intervention Group	6 and 12 months
Psychological Well-being	Psychological well-being assessed to the Intervention Group	Baseline, 6 and 12 months
Resilience	Resilience outcome evaluated in the Intervention Group	Baseline, 6 and 12 months
Lactate in the Intervention Group	Saliva analyses for the Lactate parameter	After the saliva collection at the baseline
NAD/NADH in the Intervention Group	Saliva analyses for theNAD/NADH parameter	After the saliva collection at the baseline
TBARS in the Intervention Group	Saliva analyses for the TBARS parameter	After the saliva collection at the baseline
TNF-alfa in the Intervention Group	Saliva analyses for theTNF-alfa parameter	After the saliva collection at the baseline
IL-1b in the Intervention Group	Saliva analyses for the IL-1b parameter	After the saliva collection at the baseline
IL-6 in the Intervention Group	Saliva analyses for the IL-6 parameter	After the saliva collection at the baseline
IL-8 in the Intervention Group	Saliva analyses for the IL-8 parameter	After the saliva collection at the baseline
Microbioma saliva analysis in a sub-group of the Intervention Group	The microbioma saliva sample will be analysed in 210 subjects from the Intervention Group through the DNA GENOTEK OME-505 Omnigene Oral Collection Kits for Nucleic Acid Saliva	After the saliva collection at the baseline

Collaborators and Investigators

• Sponsor: Alberto Pilotto
• Investigators: Principal Investigator: Alberto Pilotto, Director of the Department of Geriatric Care, orthogeroatric and rehabilitation, EO Galliera Hospital, Genova, Italy

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Older people; Comprehensive Geriatric Assessment; Primary care setting; Saliva collection; Non-communicable chronic diseases; Personalized Prevention Program
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Frailty; Noncommunicable Diseases
• Other Study ID Numbers: PNRR-MAD-2022-12376781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results referred to the groups of subjects will be published in one or more different papers with only statistically significant data with the description of statistical methods of the analyses. No individual or personal data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No