PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT01699984
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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.

Resource links provided by NLM:


Further study details as provided by IRCCS Centro San Giovanni di Dio Fatebenefratelli:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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
Study Population

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

Criteria

Inclusion Criteria:

  • age 65 or older
  • informed consent provided

Exclusion Criteria:

  • younger than 65 years
  • informed consent not provided
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699984

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
Sponsors and Collaborators
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Investigators
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 August 25, 2014