Actively Recruiting
Led by Alberto Pilotto · Updated on 2024-08-28
1216
Participants Needed
4
Research Sites
N/A
Total Duration
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 program's impact.
CONDITIONS
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
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 4 locations
1
Polimedica Societa' Cooperativa
Bari, Italy
Actively Recruiting
2
Medici Insieme Garda Valsabbia Societa' Cooperativa
Desenzano del Garda, Italy
Actively Recruiting
3
Ambulatori medici
Florence, Italy
Actively Recruiting
4
COMEGEN Società Cooperativa Sociale
Naples, Italy
Actively Recruiting
A
Alberto Pilotto
M
Marina Barbagelata
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Alberto Pilotto, Wanda Morganti, Emanuele Seminerio...
https://pubmed.ncbi.nlm.nih.gov/41146026Alberto Pilotto, Marina Barbagelata, Eleonora Lacorte...
https://pubmed.ncbi.nlm.nih.gov/39272196