Clinical trial NCT05822154: Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)
Official title: Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ageing
Frailty
Keywords: ageing
comprehensive geriatric assessment
polypharmacy
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2023-04-20
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients from different settings (inpatients and outpatients) who attend the hospitals of the participating centres.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* subjects with 65 years or older

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Change in health conditions
timeFrame: Baseline, 3, 6 and 12 months later
measure: Change in prevalence of polypharmacy
timeFrame: Baseline, 3, 6 and 12 months later
Secondary outcomes:
measure: Change in frailty condition
timeFrame: Baseline, 3, 6 and 12 months later
measure: Change in functional capacity
timeFrame: Baseline, 3, 6 and 12 months later
measure: Change in functional capacity
timeFrame: Baseline, 3, 6 and 12 months later
measure: Change in physical performance
timeFrame: Baseline, 3, 6 and 12 months later
measure: Change of cognitive function score
timeFrame: Baseline, 3, 6 and 12 months late
Other outcomes:
Locations:
city: Cosenza
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Cosenza, Italy
name: Andrea Corsonello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
name: Simona Ciccone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
name: Antonio Greco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS "Saverio de Bellis", Castellana Grotte (BA), Italy
name: Rodolfo Sardone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Don Carlo Gnocchi, Milano, Italy
name: Fabrizio Giunco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia, Roma, Italy
name: Mariacristina Parravano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico San Matteo, Pavia, Italy
name: Marco Lenti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario A. Gemelli, Roma, Italy
name: Rosa Liperoti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Auxologico Italiano, Milano, Italy
name: Francesca Bruni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituti Clinici Scientifici Maugeri, Scientific Institute of Telese Terme (BN), Italy
name: Giuseppe Rengo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Ortopedico Rizzoli, Bologna, Italy
name: Milena Fini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Ortopedico Galeazzi, Milano, Italy
name: Luigi Zagra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy
name: Alessandro Nobili, MD
role: PRINCIPAL_INVESTIGATOR
References: