Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)

NCT05822154 | Unknown

• 1 other identifier: INRCA_001_2023
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Ageing; Frailty

Keywords

ageing; comprehensive geriatric assessment; polypharmacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in frailty condition

  Baseline, 3, 6 and 12 months later

• Change in functional capacity

  Baseline, 3, 6 and 12 months later

• Change in functional capacity

  Baseline, 3, 6 and 12 months later

• Change in physical performance

  Baseline, 3, 6 and 12 months later

• Change of cognitive function score

  Baseline, 3, 6 and 12 months late

Study Arms (1)

elderly subjects

subjects aged 65 years and over

Other: comprehensive geriatric assessment

Interventions

comprehensive geriatric assessment OTHER

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

elderly subjects

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• subjects with 65 years or older

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS INRCA Hospital

Cosenza, Italy

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rita Bonfigli, PhD

CONTACT

00390718003719; a.bonfigli@inrca.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 20, 2023
• Study Start: October 3, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)