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

NCT01397682 | Unknown

• 1 other identifier: INRCA-01-2011
• Study Type: observational
• Target: 2,250
• Locations: 1 country
• Sites: 4

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.

Conditions

Aging; Inpatients

Keywords

Comprehensive Geriatric Assessment; Frail elderly; Italy/epidemiology; Geriatric Health Service; Polypharmacy; Biological Markers; Epidemiologic Research Design

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• 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

Interventions

blood sample collection OTHER

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Study Sites (4)

INRCA Research Hospital

Ancona, I-60131, Italy

Location

INRCA Research Hospital

Casatenovo, Italy

Location

INRCA Research Hospital

Cosenza, Italy

Location

INRCA Research Hospital

Fermo, Italy

Location

Related Publications (5)

• 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.

  PMID: 20634645 BACKGROUND

• 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.

  PMID: 37990223 DERIVED

• 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.

  PMID: 34384766 DERIVED

• 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.

  PMID: 29087448 DERIVED

• 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.

  PMID: 25809054 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, whole blood

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 19, 2011
• Study Start: May 5, 2011
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

IT (4)