PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients

NCT01699984 | Completed DMC

• 1 other identifier: 2012-1-PEV
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Dementia; Motor Impairments; Stroke; Thighbone Fractures

Keywords

Cognitive impairment.; Geriatrics.; Hospital admission.; Hospital discharge.

Outcome Measures

Primary Outcomes (1)

• evaluation of clinical improvement

  from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up

Secondary Outcomes (1)

• identification of variables predictive of outcomes

  at discharge (or 3 months after admission) and 6 months follow-up

Other Outcomes (1)

• evaluation of predictive abilities of clinicians

  admission, discharge (or 3 months of hospitalization) and 6 months follow-up

Study Arms (1)

Hospitalized patients

All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• age 65 or older
• informed consent provided

You may not qualify if:

• younger than 65 years
• informed consent not provided

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (4)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Brescia, 25125, Italy

Location

Sacro Cuore di Gesù Centre

San Colombano al Lambro, Milan, 20078, Italy

Location

beata Vergine della Consolata Hospital

San Maurizio Canavese, Turin, 10077, Italy

Location

San Raffaele Arcangelo Hospital

Venezia, Venezia, 30121, Italy

Location

Related Links

• Website of the coordinating centre

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for the assessment of APOE genetic polymorphisms; routine lab examinations.

MeSH Terms

Conditions

Dementia; Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders

Study Officials

• Giovanni de Girolamo, M.D.

  IRCCS Centro San Giovanni di Dio Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Scientific Director

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

IT (4)