PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients

October 2, 2012 updated by: Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli

THE HOSPITALIZATION OF OLDER PATIENTS: RISK FACTORS, ADVERSE EVENTS AND OUTCOMES. A MULTICENTRE STUDY.

This prospective observational cohort study aims at studying functional and clinical outcomes of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order in Northern Italy during an index period of 4 months. Other areas assessed include variables that help or hinder the discharge of patients with sufficient residential autonomy and the predictive ability of clinicians compared with the evaluation of selective indicators of outcome (clinical and instrumental).

Patients are followed from the first day of hospitalization until discharge or up to 3 months and 1 day after the date of admission ("long-term care" patients).

At admission a "Patient Form" including social, demographic and clinical informations and a series of standardized assessment tools is completed with the help of clinicians, nurses and caregivers (when available).

For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is performed and adverse events occurred during hospitalization are monitored, as well as the predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at discharge (or after 3 months for "long-term care" patients) and at 6 months follow-up of with a standardized telephone interview to assess clinical and functional status and possible changes in the residential status of the patient.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

329

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25125
        • IRCCS Centro San Giovanni di Dio Fatebenefratelli
      • Venezia, Italy, 30121
        • San Raffaele Arcangelo Hospital
    • Milan
      • San Colombano al Lambro, Milan, Italy, 20078
        • Sacro Cuore di Gesù Centre
    • Turin
      • San Maurizio Canavese, Turin, Italy, 10077
        • beata Vergine della Consolata Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged 65 or older admitted to 4 geriatric inpatient facilities.

Description

Inclusion Criteria:

  • age 65 or older
  • informed consent provided

Exclusion Criteria:

  • younger than 65 years
  • informed consent not provided

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hospitalized patients
All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluation of clinical improvement
Time Frame: from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up
from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
identification of variables predictive of outcomes
Time Frame: at discharge (or 3 months after admission) and 6 months follow-up
at discharge (or 3 months after admission) and 6 months follow-up

Other Outcome Measures

Outcome Measure
Time Frame
evaluation of predictive abilities of clinicians
Time Frame: admission, discharge (or 3 months of hospitalization) and 6 months follow-up
admission, discharge (or 3 months of hospitalization) and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Investigators

  • Principal Investigator: Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-1-PEV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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