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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aging, Inpatients

Intervention / Treatment
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* Other: blood sample collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood sample collection|A blood sample will be drawn within 24 hours from admission for determination of biomarkers and genetic analyses|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Identification of biomarkers: urinary markers of prostate disease | score PCA3mRNA/PSAmRNA | blood and urine samples drawn within 24 hours from admission | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comprehensive Geriatric Assessment, Frail elderly, Italy/epidemiology, Geriatric Health Service, Polypharmacy, Biological Markers, Epidemiologic Research Design