Personalized Prevention Program Based on Comprehensive Geriatric Assessment to Reduce Frailty and Hospitalization in Older Adults with Chronic Diseases in Primary Care
Led by Alberto Pilotto · Updated on 2024-08-28
1216
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a personalized prevention program PPP based on the Comprehensive Geriatric Assessment CGA for older adults with non-communicable chronic diseases NCDs. The study aims to reduce hospitalization rates and explore biological factors related to aging and frailty. This research involves 1216 participants recruited by General Practitioners GPs in Italy and focuses on the impact of the CGA in primary care settings.
Participants are randomly assigned to two groups an intervention group that receives the PPP guided by the CGA and a control group receiving standard clinical care. The PPP includes assessments using the Brief-MPI scale covering motor, cognitive, nutritional, medication, vaccination, daily activities, and living situation domains. Participants in the intervention group receive brochures with tailored advice for 12 months, specialist referrals if needed, and provide saliva samples for biomarker analysis. The control group continues usual care without CGA evaluation or saliva collection.
All participants will be monitored at baseline, 6 months, and 12 months with follow-up contacts to assess adherence, satisfaction, and health outcomes. Researchers will measure hospitalization rates as the primary outcome and secondary outcomes including combined health events, unplanned GP visits, and mortality rates. The study also collects data on psychological wellbeing and resilience. Statistical analyses will compare outcomes between groups over 12 months to assess the programs impact.
CONDITIONS
Brief 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
Research Team
A
Alberto Pilotto
M
Marina Barbagelata
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Not willing to participate or without signed informed consent
Younger than 65 years old
Without non-communicable chronic diseases
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Personalized Prevention Program
Duration - 12 months
Participants receive a personalized prevention program based on their Comprehensive Geriatric Assessment (CGA) results. This includes practical advice and recommendations to be implemented over 12 months, with referrals for specialist examinations if needed. Saliva samples are collected for biomarker analysis.
1 baseline visit and 2 follow-up visits at 6 and 12 months
Observation of Standard Clinical Practice
Duration - 12 months
Participants receiving standard clinical practice are observed without CGA evaluation or personalized prevention program. No saliva samples are collected.
1 baseline visit and 2 follow-up visits at 6 and 12 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study).
Alberto Pilotto, Marina Barbagelata, Eleonora Lacorte...
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.
Alberto Pilotto, Wanda Morganti, Emanuele Seminerio...