Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING) (PROMISING)

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

Study Overview

• Status: Recruiting
• Conditions: Frailty; Ageing
• Intervention / Treatment: Other: comprehensive geriatric assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Anna Rita Bonfigli, PhD; Phone Number: 00390718003719; Email: a.bonfigli@inrca.it

Study Locations

• Italy
  • Cosenza, Italy
    • Recruiting
    • IRCCS INRCA Hospital
    • Contact: Andrea Corsonello, MD; Email: a.corsonello@inrca.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients from different settings (inpatients and outpatients) who attend the hospitals of the participating centres.

Description

Inclusion Criteria:

• subjects with 65 years or older

Exclusion Criteria:

• no informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
elderly subjects; subjects aged 65 years and over	Other: comprehensive geriatric assessment; The clinical, biological and functional characteristics will be collected in elderly subjects attending the hospitals of participating centers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health conditions	The prevalence of comorbidities and their risk factors at time of enrolment	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	Baseline, 3, 6 and 12 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	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	Baseline, 3, 6 and 12 months late

Collaborators and Investigators

• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
• Collaborators: Ministry of Health, Italy
• Investigators: Principal Investigator: Andrea Corsonello, MD, IRCCS INRCA, Cosenza, Italy; Principal Investigator: Simona Ciccone, MD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; Principal Investigator: Antonio Greco, MD, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; Principal Investigator: Rodolfo Sardone, MD, IRCCS "Saverio de Bellis", Castellana Grotte (BA), Italy; Principal Investigator: Fabrizio Giunco, MD, Fondazione Don Carlo Gnocchi, Milano, Italy; Principal Investigator: Mariacristina Parravano, MD, Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia, Roma, Italy; Principal Investigator: Marco Lenti, MD, Fondazione Policlinico San Matteo, Pavia, Italy; Principal Investigator: Rosa Liperoti, MD, Fondazione Policlinico Universitario A. Gemelli, Roma, Italy; Principal Investigator: Francesca Bruni, MD, Istituto Auxologico Italiano, Milano, Italy; Principal Investigator: Giuseppe Rengo, MD, Istituti Clinici Scientifici Maugeri, Scientific Institute of Telese Terme (BN), Italy; Principal Investigator: Milena Fini, MD, Istituto Ortopedico Rizzoli, Bologna, Italy; Principal Investigator: Luigi Zagra, MD, Istituto Ortopedico Galeazzi, Milano, Italy; Principal Investigator: Alessandro Nobili, MD, Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: comprehensive geriatric assessment; polypharmacy; ageing
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: INRCA_001_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No