Clinical trial NCT06224556: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 1216
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization rate
timeFrame: 12 months
Secondary outcomes:
measure: Composed outcome
timeFrame: 6 and 12 months
measure: Number of unplanned General Practitioners visits
timeFrame: 12 months
measure: Mortality rate
timeFrame: 6 and 12 months
Other outcomes:
measure: Adherence at the PPP
timeFrame: 6 and 12 months
measure: Psychological Well-being
timeFrame: Baseline, 6 and 12 months
measure: Resilience
timeFrame: Baseline, 6 and 12 months
measure: Lactate in the Intervention Group
timeFrame: After the saliva collection at the baseline
measure: NAD/NADH in the Intervention Group
timeFrame: After the saliva collection at the baseline
measure: TBARS in the Intervention Group
timeFrame: After the saliva collection at the baseline
measure: TNF-alfa in the Intervention Group
timeFrame: After the saliva collection at the baseline
measure: IL-1b in the Intervention Group
timeFrame: After the saliva collection at the baseline
measure: IL-6 in the Intervention Group
timeFrame: After the saliva collection at the baseline
measure: IL-8 in the Intervention Group
timeFrame: After the saliva collection at the baseline
measure: Microbioma saliva analysis in a sub-group of the Intervention Group
timeFrame: After the saliva collection at the baseline
Locations:
city: Bari
country: Italy
facility: Polimedica Societa' Cooperativa
city: Desenzano Del Garda
country: Italy
facility: Medici Insieme Garda Valsabbia Societa' Cooperativa
city: Firenze
country: Italy
facility: Ambulatori medici
city: Napoli
country: Italy
facility: COMEGEN Società Cooperativa Sociale
Study officials:
affiliation: Director of the Department of Geriatric Care, orthogeroatric and rehabilitation, EO Galliera Hospital, Genova, Italy
name: Alberto Pilotto
role: PRINCIPAL_INVESTIGATOR
References: