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

Older People Clinical Trial

— PrimaCare_P3  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06224556
• Other study ID #: PNRR-MAD-2022-12376781
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: Alberto Pilotto
• Phone: 0039 0105634467
• Email: alberto.pilotto[@]galliera.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1216
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Frailty
• Non-Communicable Chronic Diseases
• Noncommunicable Diseases
• Older People

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alberto Pilotto

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence at the PPP	Adherence at the Personalized Prevention Program by the Intervention Group	6 and 12 months
Other	Psychological Well-being	Psychological well-being assessed to the Intervention Group	Baseline, 6 and 12 months
Other	Resilience	Resilience outcome evaluated in the Intervention Group	Baseline, 6 and 12 months
Other	Lactate in the Intervention Group	Saliva analyses for the Lactate parameter	After the saliva collection at the baseline
Other	NAD/NADH in the Intervention Group	Saliva analyses for theNAD/NADH parameter	After the saliva collection at the baseline
Other	TBARS in the Intervention Group	Saliva analyses for the TBARS parameter	After the saliva collection at the baseline
Other	TNF-alfa in the Intervention Group	Saliva analyses for theTNF-alfa parameter	After the saliva collection at the baseline
Other	IL-1b in the Intervention Group	Saliva analyses for the IL-1b parameter	After the saliva collection at the baseline
Other	IL-6 in the Intervention Group	Saliva analyses for the IL-6 parameter	After the saliva collection at the baseline
Other	IL-8 in the Intervention Group	Saliva analyses for the IL-8 parameter	After the saliva collection at the baseline
Other	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
Primary	Hospitalization rate	Unplanned hospitalization rate	12 months
Secondary	Composed outcome	Composed outcome including: emergency access rate, hospitalization and institutionalization rates at 6 and 12 months after the baseline.	6 and 12 months
Secondary	Number of unplanned General Practitioners visits	Unplanned GPs visits	12 months
Secondary	Mortality rate	mortality rate at 6 and 12 months	6 and 12 months