<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/NCT01701765</url>
  </required_header>
  <id_info>
    <org_study_id>2012-2-PEV</org_study_id>
    <nct_id>NCT01701765</nct_id>
  </id_info>
  <brief_title>Outcomes and Discharge of Long-stay Psychiatric Patients</brief_title>
  <acronym>PERDOVE</acronym>
  <official_title>Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)</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>
      An increasing number of severely ill patients require long-term care in non-hospital&#xD;
      Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed&#xD;
      longitudinal studies on fairly larger samples of residents have provided important&#xD;
      information about this population. The PERDOVE study is the first study carried out in Italy&#xD;
      aimed at obtaining comprehensive data about the course and outcome of patients living in RFs,&#xD;
      and test whether discharge to independent accommodations is a real option for many patients.&#xD;
      The major aims are three: (1) to describe the sociodemographic, clinical, and&#xD;
      treatment-related characteristics of patients treated in RFs during an index period in 2010;&#xD;
      (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up;&#xD;
      and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each&#xD;
      individual patient. The primary endpoint was discharge within one year as a measure of good&#xD;
      outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging&#xD;
      to the St John of God Order, located in Northern Italy. The first step involves the&#xD;
      evaluation of all RFs with a Structure Schedule, which assesses the following areas:&#xD;
      logistics structure, general organization: internal rules, meals, clothing and personal&#xD;
      hygiene; staff and users' characteristics and meetings, documentation system and evaluation&#xD;
      activities; rehabilitative activities provided inside the RF itself. In the second step a&#xD;
      research assistant completed a standardised assessment of each resident with the manager and&#xD;
      staff; clinical diagnoses were made by treating clinicians. A number of standardised&#xD;
      instruments were administered. At one year follow-up, changes in clinical and life conditions&#xD;
      of the patients were evaluated and selected rating scales were administered again. For&#xD;
      patients discharged to the community or to other RFs, a research assistant contacted the&#xD;
      patient's psychiatrist and asked him/her to fill out the follow-up documentation. With regard&#xD;
      to residents' discharge, investigators hypothesised that the likelihood of community&#xD;
      discharge would be associated both with the level of social support outside the facilities,&#xD;
      and with the degree of patients' psychological and social impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 2011</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>Discharge</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of patients discharged home one year after the baseline assessment compared to patients staying in the same residential facility or transferred to other institutions (e.g., other residential facilities, nursing homes, jails, etc)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scores of standardized rating scales</measure>
    <time_frame>1 year</time_frame>
    <description>Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction assessed with the VSSS</measure>
    <time_frame>1 year</time_frame>
    <description>Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">403</enrollment>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>Patients in residential facilities</arm_group_label>
    <description>All patients staying in September 2010 in 23 medium-long term RFs of the St John of God Order in Northern Italy with a primary psychiatric diagnosis and younger than 65 years recruited.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Psychiatric patients staying in residential facilities.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  psychiatric diagnosis&#xD;
&#xD;
          -  age &lt; 65&#xD;
&#xD;
          -  staying in september 2010 in any of 23 RFs located in Northern Italy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  elderly patients (over 65 yrs)&#xD;
&#xD;
          -  primary diagnosis of organic mental disorder&#xD;
&#xD;
          -  refusal of signing an informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</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>IRCSS Sant'Ambrogio</name>
      <address>
        <city>Cernusco sul Naviglio</city>
        <state>Milano</state>
        <zip>20063</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Sacro Cuore di Gesù</name>
      <address>
        <city>San Colombano al Lambro</city>
        <state>Milano</state>
        <zip>20078</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Presidio Ospedaliero Beata Verigine della Consolata</name>
      <address>
        <city>San Maurizio Canavese</city>
        <state>Torino</state>
        <zip>10077</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Centro san Giovanni di Dio</name>
      <address>
        <city>Brescia</city>
        <zip>20125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 6, 2012</last_update_submitted>
  <last_update_submitted_qc>October 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 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.</investigator_title>
  </responsible_party>
  <keyword>Severe mental disorders</keyword>
  <keyword>Discharge</keyword>
  <keyword>Outcome evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</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/NCT01701765
org study id: 2012-2-PEV
nct id: NCT01701765
lead sponsor: 
has dmc: Yes
An increasing number of severely ill patients require long-term care in non-hospital
      Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed
      longitudinal studies on fairly larger samples of residents have provided important
      information about this population. The PERDOVE study is the first study carried out in Italy
      aimed at obtaining comprehensive data about the course and outcome of patients living in RFs,
      and test whether discharge to independent accommodations is a real option for many patients.
      The major aims are three: (1) to describe the sociodemographic, clinical, and
      treatment-related characteristics of patients treated in RFs during an index period in 2010;
      (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up;
      and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each
      individual patient. The primary endpoint was discharge within one year as a measure of good
      outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging
      to the St John of God Order, located in Northern Italy. The first step involves the
      evaluation of all RFs with a Structure Schedule, which assesses the following areas:
      logistics structure, general organization: internal rules, meals, clothing and personal
      hygiene; staff and users' characteristics and meetings, documentation system and evaluation
      activities; rehabilitative activities provided inside the RF itself. In the second step a
      research assistant completed a standardised assessment of each resident with the manager and
      staff; clinical diagnoses were made by treating clinicians. A number of standardised
      instruments were administered. At one year follow-up, changes in clinical and life conditions
      of the patients were evaluated and selected rating scales were administered again. For
      patients discharged to the community or to other RFs, a research assistant contacted the
      patient's psychiatrist and asked him/her to fill out the follow-up documentation. With regard
      to residents' discharge, investigators hypothesised that the likelihood of community
      discharge would be associated both with the level of social support outside the facilities,
      and with the degree of patients' psychological and social impairment.
observational model: Cohort
time perspective: Prospective
measure: Discharge
time frame: 1 year
description: Percentage of patients discharged home one year after the baseline assessment compared to patients staying in the same residential facility or transferred to other institutions (e.g., other residential facilities, nursing homes, jails, etc)
measure: Scores of standardized rating scales
time frame: 1 year
description: Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)
measure: Satisfaction assessed with the VSSS
time frame: 1 year
description: Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.
arm group label: Patients in residential facilities
description: All patients staying in September 2010 in 23 medium-long term RFs of the St John of God Order in Northern Italy with a primary psychiatric diagnosis and younger than 65 years recruited.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
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
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.
mesh term: Mental Disorders
mesh term: Psychotic Disorders