Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals (report-AGE)

October 19, 2023 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
The goal of this research study is to collect clinical data, comprehensive geriatric assessment, risk factors, biological data and blood samples from inpatients aged 65 and older at the INRCA research hospitals (Italy). All data will be stored in a research bank and used to better clarify the mechanisms underlying the condition of "frailty" in aged patients. The database will be created on the INRCA server platform by establishing a safe HTTPS protocol.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Life expectancy is continuously increasing in Italy. Aging is generally linked to adaptive modifications of organs and systems that reduce the functional reserve and increase the vulnerability to disease and addiction. This framework constitutes the condition of "frailty", which is associated to an increased risk of multiple adverse events as falls, fractures, disability, institutionalisation and death. To reduce the burden of disability and diseases affecting the quality of life of the elderly and, at the same time weighs heavily on health costs, a high level of managerial efficiency has to be achieved, planning the necessary health and care services and implementing measures to prevent disability in the fragile elderly. Indeed a strongly expanding area of gerontological and geriatric research is focusing on successful aging, that is characterised by a low probability of diseases and related disabilities, by a high level of physical and cognitive functionality and by an active social involvement in daily life. For this reason the project is based on the implementation of a validated system of comprehensive geriatric assessment able to provide detailed measures of the different possible interactions among risk factors. The study aimed at the descriptive-epidemiological collection of the health conditions of older in-patients at the different INRCA research hospitals (Italy). The data set will include personal data, information from the comprehensive geriatric assessment, clinical-care, biological and diagnostic data, collected routinely as well as ad hoc during hospitalisation. Moreover, a blood sample will be taken to performing biomarkers and genetic analyses.

Study Type

Observational

Enrollment (Estimated)

2250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, I-60131
        • INRCA Research Hospital
      • Casatenovo, Italy
        • INRCA Research Hospital
      • Cosenza, Italy
        • INRCA Research Hospital
      • Fermo, Italy
        • INRCA Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inpatients aged 65 or older at the INRCA research hospital facilities of Ancona, Fermo, Casatenovo, Roma, Cosenza (Italy).

Description

Inclusion Criteria:

  • Aged 65 or older
  • Inpatients at the different INRCA research hospital facilities (Italy)

Exclusion Criteria:

  • Inpatients who have not/for those the informed consent was not given

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive-epidemiological analysis of health conditions
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Collection of a set of data and indicators of the health conditions including personal data, clinical-care, biological and diagnostic data, treatments/procedures and drug therapy.
participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument
Time Frame: within 24 hours from admission and within 24 hours prior to discharge
identification information, personal data at admission, assessment date, cognitive function, communication and vision, mood and behaviour, physical function, incontinence, diagnosis of the disease, health conditions, oral and nutrition status, skin conditions, medications, treatment and procedures, advanced directives, discharge potential, discharge, assessment information, anamnestic-clinical data, standardised clinical assessment, physical performance tests
within 24 hours from admission and within 24 hours prior to discharge
Assessment of the functional capacities through specific performance tests
Time Frame: within 24 hours from admission and within 24 hours prior to discharge
walking test, steps test, "chair standing", hand grip, articular extrusion
within 24 hours from admission and within 24 hours prior to discharge
Evaluation of drugs consumption
Time Frame: within 24 hours from admission, during hospital stay and at discharge
Drugs prior to admission, Drugs administered during hospital stay, Prescribed drugs at discharge
within 24 hours from admission, during hospital stay and at discharge
Identification of biomarkers: urinary markers of prostate disease
Time Frame: blood and urine samples drawn within 24 hours from admission
score PCA3mRNA/PSAmRNA
blood and urine samples drawn within 24 hours from admission
Identification of biomarkers: immunological parameters
Time Frame: blood sample drawn within 24 hours from admission
Leukocyte populations phenotype, Natural Killer activity in samples of leucocytes by means of citofluorimetric analysis
blood sample drawn within 24 hours from admission
Identification of biomarkers: nutritional profile regarding trace elements
Time Frame: blood sample drawn within 24 hours from admission
Identification of trace elements (Zn, Cu, Fe, Se) and alleles of genes that express proteins involved in their homeostasis (MT1A)
blood sample drawn within 24 hours from admission
Identification of biomarkers: inflammation, oxidative stress and endothelial dysfunction
Time Frame: blood sample drawn within 24 hours from admission
parameters of inflammation (pro- and anti-inflammatory cytokines: IL-6, IL-1, TNF-alpha, IL-10, IL-2, IL-17, IL-8; pro- and anti-inflammatory chemokines: MCP-1 and RANTES), parameters of oxidative stress (plasma total antioxidant capacity, determination of catalase, glutathione peroxidase, superoxide dismutase), and parameters of endothelial dysfunction (ADMA, SDMA, L-arginine, PAI-1)
blood sample drawn within 24 hours from admission
Genetic analyses
Time Frame: blood sample drawn within 24 hours from admission
assessment of: plasmatic and cellular (leukocytes) microRNA, mitochondrial DNA polymorphisms, length of telomeres of circulating leucocytes polymorphisms, epigenetic modifications of DNA in circulating leukocytes
blood sample drawn within 24 hours from admission
Genomic wide testing
Time Frame: blood sample drawn within 24 hours from admission
Genotyping by Affymetrix Genome-wide Human SNP array 6.0 will be performed by the Birdseed genotype calling algorithm, embedded in the Affymetrix Genotyping Console Software AGCS (Affymetrix), which is available at the Coordinating Center (INRCA).
blood sample drawn within 24 hours from admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

  • Principal Investigator: Silvia Bustacchini, MD, Istituto Nazionale di Ricovero e Cura per Anziani (INRCA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2011

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimated)

July 19, 2011

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INRCA-01-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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