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Clinical Trials/NCT01397682
NCT01397682
Enrolling by Invitation
N/A

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

Istituto Nazionale di Ricovero e Cura per Anziani1 site in 1 country2,250 target enrollmentMay 5, 2011
ConditionsAgingInpatients

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aging
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Enrollment
2250
Locations
1
Primary Endpoint
Descriptive-epidemiological analysis of health conditions
Status
Enrolling by Invitation
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2011
End Date
May 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument(within 24 hours from admission and within 24 hours prior to discharge)
  • Assessment of the functional capacities through specific performance tests(within 24 hours from admission and within 24 hours prior to discharge)
  • Evaluation of drugs consumption(within 24 hours from admission, during hospital stay and at discharge)
  • Identification of biomarkers: urinary markers of prostate disease(blood and urine samples drawn within 24 hours from admission)
  • Identification of biomarkers: immunological parameters(blood sample drawn within 24 hours from admission)
  • Identification of biomarkers: nutritional profile regarding trace elements(blood sample drawn within 24 hours from admission)
  • Identification of biomarkers: inflammation, oxidative stress and endothelial dysfunction(blood sample drawn within 24 hours from admission)
  • Genetic analyses(blood sample drawn within 24 hours from admission)
  • Genomic wide testing(blood sample drawn within 24 hours from admission)

Study Sites (1)

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