<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01699984</url>
  </required_header>
  <id_info>
    <org_study_id>2012-1-PEV</org_study_id>
    <nct_id>NCT01699984</nct_id>
  </id_info>
  <brief_title>PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients</brief_title>
  <official_title>THE HOSPITALIZATION OF OLDER PATIENTS: RISK FACTORS, ADVERSE EVENTS AND OUTCOMES. A MULTICENTRE STUDY.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Centro San Giovanni di Dio Fatebenefratelli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Centro San Giovanni di Dio Fatebenefratelli</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective observational cohort study aims at studying functional and clinical outcomes&#xD;
      of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order&#xD;
      in Northern Italy during an index period of 4 months. Other areas assessed include variables&#xD;
      that help or hinder the discharge of patients with sufficient residential autonomy and the&#xD;
      predictive ability of clinicians compared with the evaluation of selective indicators of&#xD;
      outcome (clinical and instrumental).&#xD;
&#xD;
      Patients are followed from the first day of hospitalization until discharge or up to 3 months&#xD;
      and 1 day after the date of admission (&quot;long-term care&quot; patients).&#xD;
&#xD;
      At admission a &quot;Patient Form&quot; including social, demographic and clinical informations and a&#xD;
      series of standardized assessment tools is completed with the help of clinicians, nurses and&#xD;
      caregivers (when available).&#xD;
&#xD;
      For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is&#xD;
      performed and adverse events occurred during hospitalization are monitored, as well as the&#xD;
      predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at&#xD;
      discharge (or after 3 months for &quot;long-term care&quot; patients) and at 6 months follow-up of with&#xD;
      a standardized telephone interview to assess clinical and functional status and possible&#xD;
      changes in the residential status of the patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation of clinical improvement</measure>
    <time_frame>from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>identification of variables predictive of outcomes</measure>
    <time_frame>at discharge (or 3 months after admission) and 6 months follow-up</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>evaluation of predictive abilities of clinicians</measure>
    <time_frame>admission, discharge (or 3 months of hospitalization) and 6 months follow-up</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">329</enrollment>
  <condition>Dementia</condition>
  <condition>Motor Impairments</condition>
  <condition>Stroke</condition>
  <condition>Thighbone Fractures</condition>
  <arm_group>
    <arm_group_label>Hospitalized patients</arm_group_label>
    <description>All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples for the assessment of APOE genetic polymorphisms; routine lab examinations.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 65 or older admitted to 4 geriatric inpatient facilities.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 65 or older&#xD;
&#xD;
          -  informed consent provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 65 years&#xD;
&#xD;
          -  informed consent not provided&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giovanni de Girolamo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Centro San Giovanni di Dio Fatebenefratelli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sacro Cuore di Gesù Centre</name>
      <address>
        <city>San Colombano al Lambro</city>
        <state>Milan</state>
        <zip>20078</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>beata Vergine della Consolata Hospital</name>
      <address>
        <city>San Maurizio Canavese</city>
        <state>Turin</state>
        <zip>10077</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Centro San Giovanni di Dio Fatebenefratelli</name>
      <address>
        <city>Brescia</city>
        <zip>25125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Raffaele Arcangelo Hospital</name>
      <address>
        <city>Venezia</city>
        <zip>30121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.irccs-fatebenefratelli.it</url>
    <description>Website of the coordinating centre</description>
  </link>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Centro San Giovanni di Dio Fatebenefratelli</investigator_affiliation>
    <investigator_full_name>Giovanni de Girolamo, M.D.</investigator_full_name>
    <investigator_title>M.D., Scientific Director</investigator_title>
  </responsible_party>
  <keyword>Cognitive impairment.</keyword>
  <keyword>Geriatrics.</keyword>
  <keyword>Hospital admission.</keyword>
  <keyword>Hospital discharge.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699984
org study id: 2012-1-PEV
nct id: NCT01699984
lead sponsor: 
has dmc: Yes
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.
observational model: Cohort
time perspective: Prospective
measure: evaluation of clinical improvement
time frame: from admission to discharge (or after 3 months of hospitalization) and 6 months follow-up
measure: identification of variables predictive of outcomes
time frame: at discharge (or 3 months after admission) and 6 months follow-up
measure: evaluation of predictive abilities of clinicians
time frame: admission, discharge (or 3 months of hospitalization) and 6 months follow-up
arm group label: Hospitalized patients
description: All patients hospitalized in 4 inpatient facilities in Northern Italy during 4 index-months.
Blood samples for the assessment of APOE genetic polymorphisms; routine lab examinations.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Giovanni de Girolamo, M.D.
role: Principal Investigator
affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
facility: 
facility: 
facility: 
facility: 
country: Italy
url: http://www.irccs-fatebenefratelli.it
description: Website of the coordinating centre
responsible party type: Principal Investigator
investigator affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
investigator full name: Giovanni de Girolamo, M.D.
investigator title: M.D., Scientific Director
mesh term: Dementia