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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr. Silvia Bustacchini, Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier:
NCT01397682
First received: July 6, 2011
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Aging
Inpatients
Other: blood sample collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals

Further study details as provided by Istituto Nazionale di Ricovero e Cura per Anziani:

Primary Outcome Measures:
  • Descriptive-epidemiological analysis of health conditions [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument [ Time Frame: within 24 hours from admission and within 24 hours prior to discharge ] [ Designated as safety issue: No ]
    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

  • Assessment of the functional capacities through specific performance tests [ Time Frame: within 24 hours from admission and within 24 hours prior to discharge ] [ Designated as safety issue: No ]
    walking test, steps test, "chair standing", hand grip, articular extrusion

  • Evaluation of drugs consumption [ Time Frame: within 24 hours from admission, during hospital stay and at discharge ] [ Designated as safety issue: No ]
    Drugs prior to admission, Drugs administered during hospital stay, Prescribed drugs at discharge

  • Identification of biomarkers: urinary markers of prostate disease [ Time Frame: blood and urine samples drawn within 24 hours from admission ] [ Designated as safety issue: No ]
    score PCA3mRNA/PSAmRNA

  • Identification of biomarkers: immunological parameters [ Time Frame: blood sample drawn within 24 hours from admission ] [ Designated as safety issue: No ]
    Leukocyte populations phenotype, Natural Killer activity in samples of leucocytes by means of citofluorimetric analysis

  • Identification of biomarkers: nutritional profile regarding trace elements [ Time Frame: blood sample drawn within 24 hours from admission ] [ Designated as safety issue: No ]
    Identification of trace elements (Zn, Cu, Fe, Se) and alleles of genes that express proteins involved in their homeostasis (MT1A)

  • Identification of biomarkers: inflammation, oxidative stress and endothelial dysfunction [ Time Frame: blood sample drawn within 24 hours from admission ] [ Designated as safety issue: No ]
    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)

  • Genetic analyses [ Time Frame: blood sample drawn within 24 hours from admission ] [ Designated as safety issue: No ]
    assessment of: plasmatic and cellular (leukocytes) microRNA, mitochondrial DNA polymorphisms, length of telomeres of circulating leucocytes polymorphisms, epigenetic modifications of DNA in circulating leukocytes

  • Genomic wide testing [ Time Frame: blood sample drawn within 24 hours from admission ] [ Designated as safety issue: No ]
    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).


Biospecimen Retention:   Samples With DNA

plasma, serum, whole blood


Estimated Enrollment: 2250
Study Start Date: September 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: blood sample collection
    A blood sample will be drawn within 24 hours from admission for determination of biomarkers and genetic analyses
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397682

Locations
Italy
INRCA Research Hospital
Ancona, Italy, I-60131
INRCA Research Hospital
Casatenovo, Italy
INRCA Research Hospital
Cosenza, Italy
INRCA Research Hospital
Fermo, Italy
INRCA Research Hospital
Roma, Italy
Sponsors and Collaborators
Istituto Nazionale di Ricovero e Cura per Anziani
Investigators
Principal Investigator: Silvia Bustacchini, MD Istituto Nazionale di Ricovero e Cura per Anziani (INRCA)
  More Information

Publications:
Responsible Party: Dr. Silvia Bustacchini, Principal Investigator, Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier: NCT01397682     History of Changes
Other Study ID Numbers: INRCA-01-2011
Study First Received: July 6, 2011
Last Updated: October 16, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Nazionale di Ricovero e Cura per Anziani:
Comprehensive Geriatric Assessment
Frail elderly
Italy/epidemiology
Geriatric Health Service
Polypharmacy
Biological Markers
Epidemiologic Research Design

ClinicalTrials.gov processed this record on August 21, 2014