Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals

Aging Clinical Trial

— report-AGE  

Official title:

Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01397682
• Other study ID #: INRCA-01-2011
• Status: Enrolling by invitation
• Start date: May 5, 2011
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2250
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Inpatients

Intervention

Other:
• blood sample collection
A blood sample will be drawn within 24 hours from admission for determination of biomarkers and genetic analyses

Locations

Country	Name	City	State
Italy	INRCA Research Hospital	Ancona
Italy	INRCA Research Hospital	Casatenovo
Italy	INRCA Research Hospital	Cosenza
Italy	INRCA Research Hospital	Fermo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Besdine RW, Wetle TF. Improving health for elderly people: an international health promotion and disease prevention agenda. Aging Clin Exp Res. 2010 Jun;22(3):219-30. doi: 10.1007/BF03324800. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive-epidemiological analysis of health conditions	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	Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument	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
Secondary	Assessment of the functional capacities through specific performance tests	walking test, steps test, "chair standing", hand grip, articular extrusion	within 24 hours from admission and within 24 hours prior to discharge
Secondary	Evaluation of drugs consumption	Drugs prior to admission, Drugs administered during hospital stay, Prescribed drugs at discharge	within 24 hours from admission, during hospital stay and at discharge
Secondary	Identification of biomarkers: urinary markers of prostate disease	score PCA3mRNA/PSAmRNA	blood and urine samples drawn within 24 hours from admission
Secondary	Identification of biomarkers: immunological parameters	Leukocyte populations phenotype, Natural Killer activity in samples of leucocytes by means of citofluorimetric analysis	blood sample drawn within 24 hours from admission
Secondary	Identification of biomarkers: nutritional profile regarding trace elements	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
Secondary	Identification of biomarkers: inflammation, oxidative stress and endothelial dysfunction	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
Secondary	Genetic analyses	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
Secondary	Genomic wide testing	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