Clinical trial NCT01699984: PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients
Official title: THE HOSPITALIZATION OF OLDER PATIENTS: RISK FACTORS, ADVERSE EVENTS AND OUTCOMES. A MULTICENTRE STUDY.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Motor Impairments
Stroke
Thighbone Fractures
Keywords: Cognitive impairment.
Geriatrics.
Hospital admission.
Hospital discharge.
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 329
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 65 or older admitted to 4 geriatric inpatient facilities.

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.


Eligibility criteria: Inclusion Criteria:

* age 65 or older
* informed consent provided

Exclusion Criteria:

* younger than 65 years
* informed consent not provided

Primary outcomes:
measure: evaluation of clinical improvement
timeFrame: from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up
Secondary outcomes:
measure: identification of variables predictive of outcomes
timeFrame: at discharge (or 3 months after admission) and 6 months follow-up
Other outcomes:
measure: evaluation of predictive abilities of clinicians
timeFrame: admission, discharge (or 3 months of hospitalization) and 6 months follow-up
Locations:
city: San Colombano al Lambro
country: Italy
facility: Sacro Cuore di Gesù Centre
state: Milan
city: San Maurizio Canavese
country: Italy
facility: beata Vergine della Consolata Hospital
state: Turin
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli
city: Venezia
country: Italy
facility: San Raffaele Arcangelo Hospital
Study officials:
affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
name: Giovanni de Girolamo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: