Older PeoplePrimaCare_P3NCT06224556
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 study testing Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program in people with Older People and Non-Communicable Chronic Diseases, run by Alberto Pilotto at 4 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older People, Non-Communicable Chronic Diseases
- What is being tested?
- Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,216 participants
- Where
- 4 sitesItaly
- Study dates
- 4 Jun 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old and over
- At least 1 non-communicable chronic disease
- Signed informed consent
Who cannot join
- not willing in partecipating in the study and no signed informed consent
- <65 years old
- without non-communicable chronic diseases
Trial locations and contacts
4 sites in 1 country.
Marina Barbagelata contact
Italy4 sites, 4 recruiting
- Recruiting
Polimedica Societa' Cooperativa
Bari
- Recruiting
Medici Insieme Garda Valsabbia Societa' Cooperativa
Desenzano del Garda
- Recruiting
Ambulatori medici
Florence
- Recruiting
COMEGEN Società Cooperativa Sociale
Naples
About this study
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
- 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
Read the 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.
- Conditions
- Older People, Non-Communicable Chronic Diseases
- Being tested
- Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program
- Keywords
- Primary care setting, Comprehensive Geriatric Assessment, Older people, Non-communicable chronic diseases, Personalized Prevention Program, Saliva collection
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention ProgramCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rate
Unplanned hospitalization rate
Measured: 12 months
Secondary outcomes (3)
Composed outcome
Composed outcome including: emergency access rate, hospitalization and institutionalization rates at 6 and 12 months after the baseline.
Measured: 6 and 12 months
Number of unplanned General Practitioners visits
Unplanned GPs visits
Measured: 12 months
Mortality rate
mortality rate at 6 and 12 months
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start4 Jun 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberto Pilotto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alberto Pilotto, Ente Ospedaliero Ospedali Galliera
- Investigators
- Alberto Pilotto, Principal investigator, Director of the Department of Geriatric Care, orthogeroatric and rehabilitation, EO Galliera Hospital, Genova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224556
- Sponsor's protocol ID
- PNRR-MAD-2022-12376781
- Acronym
- PrimaCare_P3
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 practice: preliminary data from the PrimaCare_P3 study. BMC Prim Care. 2025 Oct 27;26(1):323. doi: 10.1186/s12875-025-02951-6.
PubMed 41146026Pilotto 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.
PubMed 39272196
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06224556
- Acronym / sponsor ID
- PrimaCare_P3 / PNRR-MAD-2022-12376781
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,216 participants (estimated)
- Lead sponsor
- Alberto PilottoUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Combination Product: Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention ProgramAll 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years old and over
- At least 1 non-communicable chronic disease
- Signed informed consent
Key exclusion criteria (3 listed)
- not willing in partecipating in the study and no signed informed consent
- <65 years old
- without non-communicable chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention ProgramPatients 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. | Combination product | Intervention Group |
Primary outcome
Hospitalization rate
Time frame: 12 months
Unplanned hospitalization rate
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 41146026Pilotto 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.
- Derived from this study: PubMed 39272196Pilotto 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Barbagelata contact
Alberto Pilotto principal investigator
Director of the Department of Geriatric Care, orthogeroatric and rehabilitation, EO Galliera Hospital, Genova, Italy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program in people with Older People and Non-Communicable Chronic Diseases, run by Alberto Pilotto at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Pilotto (0039 0105634467, alberto.pilotto@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224556, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.