Clinical trial NCT01397682: Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals
Official title: Epidemiological Observatory on the Health Conditions of Inpatients Aged 65 or Older at the INRCA Research Hospitals
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aging
Inpatients
Keywords: Comprehensive Geriatric Assessment
Frail elderly
Italy/epidemiology
Geriatric Health Service
Polypharmacy
Biological Markers
Epidemiologic Research Design
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 2250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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).

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.

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

Primary outcomes:
measure: Descriptive-epidemiological analysis of health conditions
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
measure: Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument
timeFrame: within 24 hours from admission and within 24 hours prior to discharge
measure: Assessment of the functional capacities through specific performance tests
timeFrame: within 24 hours from admission and within 24 hours prior to discharge
measure: Evaluation of drugs consumption
timeFrame: within 24 hours from admission, during hospital stay and at discharge
measure: Identification of biomarkers: urinary markers of prostate disease
timeFrame: blood and urine samples drawn within 24 hours from admission
measure: Identification of biomarkers: immunological parameters
timeFrame: blood sample drawn within 24 hours from admission
measure: Identification of biomarkers: nutritional profile regarding trace elements
timeFrame: blood sample drawn within 24 hours from admission
measure: Identification of biomarkers: inflammation, oxidative stress and endothelial dysfunction
timeFrame: blood sample drawn within 24 hours from admission
measure: Genetic analyses
timeFrame: blood sample drawn within 24 hours from admission
measure: Genomic wide testing
timeFrame: blood sample drawn within 24 hours from admission
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: INRCA Research Hospital
city: Casatenovo
country: Italy
facility: INRCA Research Hospital
city: Cosenza
country: Italy
facility: INRCA Research Hospital
city: Fermo
country: Italy
facility: INRCA Research Hospital
Study officials:
References:
citation: 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.
citation: Corsonello A, Soraci L, Di Rosa M, Bustacchini S, Bonfigli AR, Lisa R, Liperoti R, Tettamanti M, Cherubini A, Antonicelli R, Pelliccioni G, Postacchini D, Lattanzio F. Prognostic Interplay of Functional Status and Multimorbidity Among Older Patients Discharged From Hospital. J Am Med Dir Assoc. 2022 Mar;23(3):499-506.e1. doi: 10.1016/j.jamda.2021.07.012. Epub 2021 Aug 9.
citation: Gagliardi C, Corsonello A, Di Rosa M, Fabbietti P, Cherubini A, Mercante O, Mazzei B, Postacchini D, Deales A, Bustacchini S, Lattanzio F. Preadmission Functional Decline Predicts Functional Improvement Among Older Patients Admitted to Acute Care Hospital. J Gerontol A Biol Sci Med Sci. 2018 Sep 11;73(10):1363-1369. doi: 10.1093/gerona/glx211.
citation: Bustacchini S, Abbatecola AM, Bonfigli AR, Chiatti C, Corsonello A, Di Stefano G, Galeazzi R, Fabbietti P, Lisa R, Guffanti EE, Provinciali M, Lattanzio F; Report-Age study group. The Report-AGE project: a permanent epidemiological observatory to identify clinical and biological markers of health outcomes in elderly hospitalized patients in Italy. Aging Clin Exp Res. 2015 Dec;27(6):893-901. doi: 10.1007/s40520-015-0350-3. Epub 2015 Mar 26.