PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients
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Purpose
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.
| Condition |
|---|
|
Dementia Motor Impairments Stroke Thighbone Fractures |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | THE HOSPITALIZATION OF OLDER PATIENTS: RISK FACTORS, ADVERSE EVENTS AND OUTCOMES. A MULTICENTRE STUDY. |
- evaluation of clinical improvement [ Time Frame: from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up ] [ Designated as safety issue: No ]
- identification of variables predictive of outcomes [ Time Frame: at discharge (or 3 months after admission) and 6 months follow-up ] [ Designated as safety issue: No ]
- evaluation of predictive abilities of clinicians [ Time Frame: admission, discharge (or 3 months of hospitalization) and 6 months follow-up ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood samples for the assessment of APOE genetic polymorphisms; routine lab examinations.
| Enrollment: | 329 |
| Study Start Date: | February 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Hospitalized patients
All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months.
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients aged 65 or older admitted to 4 geriatric inpatient facilities.
Inclusion Criteria:
- age 65 or older
- informed consent provided
Exclusion Criteria:
- younger than 65 years
- informed consent not provided
Contacts and Locations| Italy | |
| Sacro Cuore di Gesù Centre | |
| San Colombano al Lambro, Milan, Italy, 20078 | |
| beata Vergine della Consolata Hospital | |
| San Maurizio Canavese, Turin, Italy, 10077 | |
| IRCCS Centro San Giovanni di Dio Fatebenefratelli | |
| Brescia, Italy, 25125 | |
| San Raffaele Arcangelo Hospital | |
| Venezia, Italy, 30121 | |
| Principal Investigator: | Giovanni de Girolamo, M.D. | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
More Information
Additional Information:
No publications provided
| Responsible Party: | Giovanni de Girolamo, M.D., M.D., Scientific Director, IRCCS Centro San Giovanni di Dio Fatebenefratelli |
| ClinicalTrials.gov Identifier: | NCT01699984 History of Changes |
| Other Study ID Numbers: | 2012-1-PEV |
| Study First Received: | October 2, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by IRCCS Centro San Giovanni di Dio Fatebenefratelli:
|
Cognitive impairment. Geriatrics. Hospital admission. Hospital discharge. |
Additional relevant MeSH terms:
|
Dementia Stroke Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013