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Clinical trial

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

ID
Name
PNRR-MAD-2022-12376781
Description
* 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
Trial arms
Trial start
2024-02-01
Estimated PCD
2025-05-01
Trial end
2025-05-01
Status
Not yet recruiting
Treatment
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.
Arms:
Intervention Group
Size
1216
Primary endpoint
Hospitalization rate
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Intervention Group will receive the Personlized Prevention Program (PPP)\n\nbe evaluated by a Comprehensive Geriatric Assessment thanks to the Multidimensional Prognostic Index (MPI) questionnaire.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The General Practitioners (GPs) involved will be randomised in 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.\n\nTherefore, the role of GPs are masked.', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 1216, 'type': 'ESTIMATED'}}
Updated at
2024-01-25

1 organization

1 product

2 indications

Organization
Alberto Pilotto
Product
Brief-MPI assessment
Indication
Older Adults
Indication
Non-Communicable Chronic Diseases