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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program.
- Who it may be relevant to
- Registry conditions: Older People, Non-Communicable Chronic Diseases. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
* 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.
Interventions
- 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.
Primary outcome measures
- Hospitalization rate [Time frame: 12 months]
Secondary outcome measures (3)
- Composed outcome [Time frame: 6 and 12 months]
- Number of unplanned General Practitioners visits [Time frame: 12 months]
- Mortality rate [Time frame: 6 and 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Italy · 4 centers
- Polimedica Societa' Cooperativa — Bari
- Medici Insieme Garda Valsabbia Societa' Cooperativa — Desenzano del Garda
- Ambulatori medici — Florence
- COMEGEN Società Cooperativa Sociale — Naples
Publications
- 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 PMID 41146026
- 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 stu PMID 39272196
Identifiers
NCT: NCT06224556 · PNRR-MAD-2022-12376781