<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/NCT01719354</url>
  </required_header>
  <id_info>
    <org_study_id>2011/1770</org_study_id>
    <nct_id>NCT01719354</nct_id>
  </id_info>
  <brief_title>Aftercare in the Community Health Center</brief_title>
  <official_title>Aftercare in the Community Health Center - a Venue for Identifying and Coordinating Community Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a trial to examine the effects of aftercare for mental health patients in community&#xD;
      health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric&#xD;
      hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two&#xD;
      groups: intervention group (community health center, primary care) or control group&#xD;
      (Community mental health centers of District Psychiatric Service, specialist care).&#xD;
&#xD;
      The project's primary objective is to investigate the effect of community services on&#xD;
      patients' functional capacity and user satisfaction after discharge. Secondly, the number of&#xD;
      treatment days and readmissions to mental health care will be examined. The project will also&#xD;
      compare costs of hospitalization, in psychiatric hospital and community health center&#xD;
      respectively. Data will be collected from community health records, medical records and&#xD;
      patient systems in psychiatric hospital, community mental health centers of District&#xD;
      Psychiatric Service (DPS) and questionnaires filled out by patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consumption of community health service</measure>
    <time_frame>one year</time_frame>
    <description>Measure different types of community health services in hours per week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for community health services</measure>
    <time_frame>one year</time_frame>
    <description>Using IPLOS (Norw. individual-based nursing and care statistics) form with 17 variables to identify patient needs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>User satisfaction</measure>
    <time_frame>one year</time_frame>
    <description>A qualitative analysis of interviews of 10 patients who have been admitted to the District Psychiatric Service and community health center.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for community health services</measure>
    <time_frame>one year</time_frame>
    <description>Using individual-based nursing and care statistics (Norw. IPLOS) form with 17 variables to identify patient needs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of treatment days</measure>
    <time_frame>One year</time_frame>
    <description>Number of treatment days in hospital and District Psychiatric Service compared with number of treatment days in community health center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>One year</time_frame>
    <description>Readmission in hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total costs of inpatient and total costs of all health care after discharge</measure>
    <time_frame>One year</time_frame>
    <description>Costs per day in hospital; Costs per day for District Psychiatric Service; Costs per day in community health center</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>Community Health center</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aftercare in a community Health center</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AFtercare as usual in hospital/Mental health centers of District Psychiatric Service (DPS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community Health center</intervention_name>
    <description>Observation of the functioning and coordination of health care before discharge to own home.</description>
    <arm_group_label>Community Health center</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>standard aftercare in hospital/mental health centers of District Psychiatric Service (DPS).</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  considered by the responsible manager to have given consent&#xD;
&#xD;
          -  hospitalized, diagnosed and treated such as can be continued in a District Psychiatric&#xD;
             Service or a health center.&#xD;
&#xD;
          -  stable condition, but anxiety and disruptive behavior may occur to a lesser extent.&#xD;
&#xD;
          -  considered to have a perceived need for complex services from specialist health and&#xD;
             community for a long time after discharge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not in a stable phase thus shielding required&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aslak Steinsbekk, prof</last_name>
    <role>Study Director</role>
    <affiliation>NTNU, Department of Public Health and General Practice</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Committees for Medical and Health Research Ethics</name>
      <address>
        <city>Trondheim</city>
        <zip>7489</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>February 12, 2017</last_update_submitted>
  <last_update_submitted_qc>February 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community Mental Health Centers</keyword>
  <keyword>Norway</keyword>
  <keyword>Aftercare</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental 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/NCT01719354
org study id: 2011/1770
nct id: NCT01719354
lead sponsor: 
collaborator: 
has dmc: No
This is a trial to examine the effects of aftercare for mental health patients in community
      health center (Leistad). Recruitment occurs among hospitalized patients in psychiatric
      hospitals (Østmarka). After discharge, patients will be randomly assigned to one of two
      groups: intervention group (community health center, primary care) or control group
      (Community mental health centers of District Psychiatric Service, specialist care).

      The project's primary objective is to investigate the effect of community services on
      patients' functional capacity and user satisfaction after discharge. Secondly, the number of
      treatment days and readmissions to mental health care will be examined. The project will also
      compare costs of hospitalization, in psychiatric hospital and community health center
      respectively. Data will be collected from community health records, medical records and
      patient systems in psychiatric hospital, community mental health centers of District
      Psychiatric Service (DPS) and questionnaires filled out by patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Consumption of community health service
time frame: one year
description: Measure different types of community health services in hours per week.
measure: Need for community health services
time frame: one year
description: Using IPLOS (Norw. individual-based nursing and care statistics) form with 17 variables to identify patient needs
measure: User satisfaction
time frame: one year
description: A qualitative analysis of interviews of 10 patients who have been admitted to the District Psychiatric Service and community health center.
measure: Need for community health services
time frame: one year
description: Using individual-based nursing and care statistics (Norw. IPLOS) form with 17 variables to identify patient needs
measure: Number of treatment days
time frame: One year
description: Number of treatment days in hospital and District Psychiatric Service compared with number of treatment days in community health center.
measure: Readmission
time frame: One year
description: Readmission in hospital.
measure: The total costs of inpatient and total costs of all health care after discharge
time frame: One year
description: Costs per day in hospital; Costs per day for District Psychiatric Service; Costs per day in community health center
arm group label: Community Health center
arm group type: Experimental
description: Aftercare in a community Health center
arm group label: Control
arm group type: Active Comparator
description: AFtercare as usual in hospital/Mental health centers of District Psychiatric Service (DPS.
intervention type: Other
intervention name: Community Health center
description: Observation of the functioning and coordination of health care before discharge to own home.
arm group label: Community Health center
intervention type: Other
intervention name: Control
description: standard aftercare in hospital/mental health centers of District Psychiatric Service (DPS).
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aslak Steinsbekk, prof
role: Study Director
affiliation: NTNU, Department of Public Health and General Practice
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Mental Disorders