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Agingreport-AGENCT01397682

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

An observational study of Aging and Inpatients, run by Istituto Nazionale di Ricovero e Cura per Anziani at 4 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aging, Inpatients
What is being tested?
blood sample collection
How many people
2,250 participants
Where
4 sitesItaly
Study dates
5 May 2011to May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Inpatients aged 65 or older at the INRCA research hospital facilities of Ancona, Fermo, Casatenovo, Roma, Cosenza (Italy).

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • INRCA Research Hospital

    Ancona, I-60131

  • INRCA Research Hospital

    Casatenovo

  • INRCA Research Hospital

    Cosenza

  • INRCA Research Hospital

    Fermo

Other trials in Italy

About this study

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.

Read the 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.

Conditions
Aging, Inpatients
Being tested
blood sample collection
Keywords
Comprehensive Geriatric Assessment, Frail elderly, Italy/epidemiology, Geriatric Health Service, Polypharmacy, Biological Markers, Epidemiologic Research Design

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood sample collectionOther

    A blood sample will be drawn within 24 hours from admission for determination of biomarkers and genetic analyses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary outcomes (9)

  1. 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

    Measured: within 24 hours from admission and within 24 hours prior to discharge

  2. Assessment of the functional capacities through specific performance tests

    walking test, steps test, "chair standing", hand grip, articular extrusion

    Measured: within 24 hours from admission and within 24 hours prior to discharge

  3. Evaluation of drugs consumption

    Drugs prior to admission, Drugs administered during hospital stay, Prescribed drugs at discharge

    Measured: within 24 hours from admission, during hospital stay and at discharge

  4. Identification of biomarkers: urinary markers of prostate disease

    score PCA3mRNA/PSAmRNA

    Measured: blood and urine samples drawn within 24 hours from admission

  5. Identification of biomarkers: immunological parameters

    Leukocyte populations phenotype, Natural Killer activity in samples of leucocytes by means of citofluorimetric analysis

    Measured: blood sample drawn within 24 hours from admission

  6. 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)

    Measured: blood sample drawn within 24 hours from admission

  7. 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)

    Measured: blood sample drawn within 24 hours from admission

  8. 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

    Measured: blood sample drawn within 24 hours from admission

  9. 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).

    Measured: blood sample drawn within 24 hours from admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2011 (estimated)
  2. Study start5 May 2011
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
2,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01397682
Sponsor's protocol ID
INRCA-01-2011
Acronym
report-AGE
Status last verified
Oct 2023
First submitted
6 Jul 2011
Last updated
23 Oct 2023
Results posted
No

Publications

  • 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.

    PubMed 20634645

  • Di Rosa M, Sabbatinelli J, Soraci L, Corsonello A, Bonfigli AR, Cherubini A, Sarzani R, Antonicelli R, Pelliccioni G, Galeazzi R, Marchegiani F, Iuorio S, Colombo D, Burattini M, Lattanzio F, Olivieri F. Neutrophil-to-lymphocyte ratio (NLR) predicts mortality in hospitalized geriatric patients independent of the admission diagnosis: a multicenter prospective cohort study. J Transl Med. 2023 Nov 21;21(1):835. doi: 10.1186/s12967-023-04717-z.

    PubMed 37990223

  • 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.

    PubMed 34384766

  • 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.

    PubMed 29087448

  • 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.

    PubMed 25809054

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and Inpatients, run by Istituto Nazionale di Ricovero e Cura per Anziani at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Descriptive-epidemiological analysis of health conditions (time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01397682, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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