NCT05822154 - Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING) | Crick | Crick

Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)

N/AUnknownNCT05822154

Istituto Nazionale di Ricovero e Cura per Anziani400 enrolled

Overview

The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects.

The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects. Short- to medium-term outcomes will also be evaluated through follow-up.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Interventions

comprehensive geriatric assessmentOTHER

The clinical, biological and functional characteristics will be collected in elderly subjects attending the hospitals of participating centers.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * subjects with 65 years or older Exclusion Criteria: * no informed consent

Locations (1)

IRCCS INRCA Hospital

Cosenza, Italy

RECRUITING

Outcomes

Primary Outcomes

Change in health conditions

The prevalence of comorbidities and their risk factors at time of enrolment

Time frame: Baseline, 3, 6 and 12 months later

Change in prevalence of polypharmacy

Number of participants with polypharmacy. Polypharmacy will be defined as being on five or more medications at one time

Time frame: Baseline, 3, 6 and 12 months later

Secondary Outcomes

Change in frailty condition

Clinical Frailty Scale (CFS). The CFS divides patients into 9 classes from very fit (CFS=1) to terminally ill (CFS=9)

Time frame: Baseline, 3, 6 and 12 months later

Change in functional capacity

Activity of Daily Living (ADL). A summary score ranges from 0 (low function, dependent) to 6 (high function, independent)

Time frame: Baseline, 3, 6 and 12 months later

Change in functional capacity

Activity of Instrumental of Daily Living (IADL). A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)

Time frame: Baseline, 3, 6 and 12 months later

Change in physical performance

Physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance

Time frame: Baseline, 3, 6 and 12 months later

Change of cognitive function score

Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function

Central Contacts

Anna Rita Bonfigli, PhD

CONTACT

00390718003719 a.bonfigli@inrca.it

Data from ClinicalTrials.gov

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