PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699984
• Other study ID #: 2012-1-PEV
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: October 2, 2012
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age 65 or older

• informed consent provided

Exclusion Criteria:

• younger than 65 years

• informed consent not provided

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dementia
• Motor Impairments
• Stroke
• Thighbone Fractures

Locations

Country	Name	City	State
Italy	IRCCS Centro San Giovanni di Dio Fatebenefratelli	Brescia
Italy	Sacro Cuore di Gesù Centre	San Colombano al Lambro	Milan
Italy	beata Vergine della Consolata Hospital	San Maurizio Canavese	Turin
Italy	San Raffaele Arcangelo Hospital	Venezia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro San Giovanni di Dio Fatebenefratelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	evaluation of predictive abilities of clinicians		admission, discharge (or 3 months of hospitalization) and 6 months follow-up	No
Primary	evaluation of clinical improvement		from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up	No
Secondary	identification of variables predictive of outcomes		at discharge (or 3 months after admission) and 6 months follow-up	No

External Links

•   Website of the coordinating centre