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临床试验/NCT01397682
NCT01397682Enrolling By Invitation不适用

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 个研究点 分布在 1 个国家目标入组 2,250 人开始时间: 2011年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
2,250
试验地点
1
主要终点
Descriptive-epidemiological analysis of health conditions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Descriptive-epidemiological analysis of health conditions

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Istituto Nazionale di Ricovero e Cura per Anziani
申办方类型
Other
责任方
Sponsor

研究点 (1)

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