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

ConditionsOlder People Non-Communicable Chronic Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorAlberto Pilotto

About this trial

* 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

65 years old and over

At least 1 non-communicable chronic disease

Signed informed consent

Disqualifiers

not willing in partecipating in the study and no signed informed consent

<65 years old

without non-communicable chronic diseases

Trial design

Design model

Parallel

Treatments tested in this trial

Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program
Combination 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.

Treatment groups

1,216 Participants

are divided into 2 treatment groups

Group A: Intervention GroupExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Hospitalization rate

Unplanned hospitalization rate

Time frame

12 months

Secondary outcomes

Composed outcome

Composed outcome including: emergency access rate, hospitalization and institutionalization rates at 6 and 12 months after the baseline.

Time frame

6 and 12 months

Number of unplanned General Practitioners visits

Unplanned GPs visits

Time frame

12 months

Mortality rate

mortality rate at 6 and 12 months

Time frame

6 and 12 months

Other outcomes

Adherence at the PPP

Adherence at the Personalized Prevention Program by the Intervention Group

Time frame

6 and 12 months

Psychological Well-being

Psychological well-being assessed to the Intervention Group

Time frame

Baseline, 6 and 12 months

Resilience

Resilience outcome evaluated in the Intervention Group

Time frame

Baseline, 6 and 12 months

Lactate in the Intervention Group

Saliva analyses for the Lactate parameter

Time frame

After the saliva collection at the baseline

Sponsors and contacts

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Alberto Pilotto

Lead sponsor

Ente Ospedaliero Ospedali Galliera

Sponsor institution

Source ClinicalTrials.gov

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