<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/NCT03250026</url>
  </required_header>
  <id_info>
    <org_study_id>459-17</org_study_id>
    <nct_id>NCT03250026</nct_id>
  </id_info>
  <brief_title>Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE</brief_title>
  <acronym>CO-WORK-CARE</acronym>
  <official_title>Cooperation for Patients With Common Mental Disorders: Care Manager Function at the Primary Care Centre and Intervention at the Workplace - CO-WORK-CARE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate whether a convergence dialogue during sick leave, between the&#xD;
      employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion&#xD;
      leader, leads to reduced sick leave time compared to those individuals who only have contact&#xD;
      with a Care Manager during the period of sick leave. The study will be performed as a&#xD;
      randomised controlled trial with randomisation at the PCC level where intervention PCCs&#xD;
      offers a convergence dialogue meeting with the work place representative during sick leave in&#xD;
      addition to Care Manager contact.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Sweden sick leave time and frequency are increasing. This is primarily in the area of&#xD;
      common mental disorders (CMD), and CMD is now the most common single cause of sickness&#xD;
      absence. Primary care is the area in which most individuals with mental illness seek care and&#xD;
      also receive care. A Care Manager function at the primary care centre (PCC) where the Care&#xD;
      Manager is responsible for the support and close contact with patients with CMD and act as&#xD;
      the &quot;spider in the web&quot; and combine patient support with other measures, have been shown to&#xD;
      have beneficial effects for depression course. In Region Västra Götaland an implementation of&#xD;
      the Care Manager function at the PCC has been set out, and the function is now available in&#xD;
      nearly 100 PCCs in the region. The present study aims to evaluate whether a convergence&#xD;
      dialogue during sick leave, between the employee and the employer, with the PCCs Rehab&#xD;
      Coordinator as discussion leader, leads to reduced sick leave time compared to those&#xD;
      individuals who only have contact with the Care Manager during the period of sick leave. The&#xD;
      study will be performed as pragmatic randomised controlled trial with randomisation at the&#xD;
      PCC level. Around 20 PCCs with a Care Manager function for patients on sick-leave with CMD&#xD;
      diagnosis will be recruited and randomized to intervention where patients in addition to a&#xD;
      Care Manager contact (12 weeks) will have one convergence dialogue meeting with the work&#xD;
      place representative during sick leave. Control PCCs will give Care Manager contact 12 weeks&#xD;
      only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Pragmatic randomised controlled trial; randomisation on primary care centre level</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net and gross sick-leave days</measure>
    <time_frame>12 months</time_frame>
    <description>number of net and gross sick-leave days during 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change of depressive symptoms Montgomery-Asberg Depression Rating Scale - Self rating version (MADRS-S) Range 0-60 (Total score) Low score better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality-of-life questionnaire score</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change of quality of life EuroQoL-5 Dimension Questionnaire(EQ-5D) Range 0-1.0(total score) low score worst outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work ability</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exhaustion</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">349</enrollment>
  <condition>Depressive Disorder</condition>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention (Workplace dialogue)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Work place convergence dialogue contact</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care Manager</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Care Manager contact 12 weeks (Care as usual)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Workplace convergence dialogue</intervention_name>
    <description>Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide</description>
    <arm_group_label>Intervention (Workplace dialogue)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care Manager</intervention_name>
    <description>Regular contact Care Manager during around 12 weeks</description>
    <arm_group_label>Care Manager</arm_group_label>
    <arm_group_label>Intervention (Workplace dialogue)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients attending primary care centers with care manager function&#xD;
&#xD;
          -  aged &gt;=18 to 67 years&#xD;
&#xD;
          -  diagnosed with a new (&lt; 1 month) depression diagnose (F32, F33), anxiety syndrome&#xD;
             (F41, F48) or stress related adjustment disorder (F43)&#xD;
&#xD;
          -  on sick-leave &gt; 14 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bipolar disorder&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  addiction&#xD;
&#xD;
          -  other serious mental disorder&#xD;
&#xD;
          -  suicidal ideation or earlier suicide attempt&#xD;
&#xD;
          -  cognitive impairment or not speaking/understanding Swedish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecilia Björkelund, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Primary Health Care, Sahlgrenska Academy</name>
      <address>
        <city>Göteborg</city>
        <state>Region Västra Götaland</state>
        <zip>40530</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <results_reference>
    <citation>Bjorkelund C, Saxvik A, Svenningsson I, Petersson EL, Wiegner L, Larsson M, Tornbom K, Wikberg C, Ariai N, Nejati S, Hensing G, Hange D. Rehabilitation cooperation and person-centred dialogue meeting for patients sick-listed for common mental disorders: 12 months follow-up of sick leave days, symptoms of depression, anxiety, stress and work ability - a pragmatic cluster randomised controlled trial from the CO-WORK-CARE project. BMJ Open. 2023 Jun 9;13(6):e074137. doi: 10.1136/bmjopen-2023-074137.</citation>
    <PMID>37295824</PMID>
  </results_reference>
  <results_reference>
    <citation>Svenningsson I, Bjorkelund C, Hange D, Wiegner L, Ariai N, Petersson EL. Symptom patterns in patients newly sick listed for common mental disorders and associations with work-related and socioeconomic factors: a cross-sectional study in Swedish primary care. BMJ Open. 2022 Jul 8;12(7):e054250. doi: 10.1136/bmjopen-2021-054250.</citation>
    <PMID>35803640</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>primary care</keyword>
  <keyword>convergence dialogue</keyword>
  <keyword>sick leave</keyword>
  <keyword>care manager</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data of individual participants will be made available to other researchers, provided reasonable request by personal contact, as soon as publication of results is effected.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available after 12 months after study completion/ alternatively as soon as publication of results is effected.</ipd_time_frame>
    <ipd_access_criteria>Data access will be reviewed by an external independent review panel.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03250026
org study id: 459-17
nct id: NCT03250026
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate whether a convergence dialogue during sick leave, between the
      employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion
      leader, leads to reduced sick leave time compared to those individuals who only have contact
      with a Care Manager during the period of sick leave. The study will be performed as a
      randomised controlled trial with randomisation at the PCC level where intervention PCCs
      offers a convergence dialogue meeting with the work place representative during sick leave in
      addition to Care Manager contact.
In Sweden sick leave time and frequency are increasing. This is primarily in the area of
      common mental disorders (CMD), and CMD is now the most common single cause of sickness
      absence. Primary care is the area in which most individuals with mental illness seek care and
      also receive care. A Care Manager function at the primary care centre (PCC) where the Care
      Manager is responsible for the support and close contact with patients with CMD and act as
      the "spider in the web" and combine patient support with other measures, have been shown to
      have beneficial effects for depression course. In Region Västra Götaland an implementation of
      the Care Manager function at the PCC has been set out, and the function is now available in
      nearly 100 PCCs in the region. The present study aims to evaluate whether a convergence
      dialogue during sick leave, between the employee and the employer, with the PCCs Rehab
      Coordinator as discussion leader, leads to reduced sick leave time compared to those
      individuals who only have contact with the Care Manager during the period of sick leave. The
      study will be performed as pragmatic randomised controlled trial with randomisation at the
      PCC level. Around 20 PCCs with a Care Manager function for patients on sick-leave with CMD
      diagnosis will be recruited and randomized to intervention where patients in addition to a
      Care Manager contact (12 weeks) will have one convergence dialogue meeting with the work
      place representative during sick leave. Control PCCs will give Care Manager contact 12 weeks
      only.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pragmatic randomised controlled trial; randomisation on primary care centre level
primary purpose: Treatment
masking: None (Open Label)
measure: Net and gross sick-leave days
time frame: 12 months
description: number of net and gross sick-leave days during 12 months
measure: Depressive symptoms
time frame: 6 and 12 months
description: Change of depressive symptoms Montgomery-Asberg Depression Rating Scale - Self rating version (MADRS-S) Range 0-60 (Total score) Low score better outcome
measure: Anxiety symptoms
time frame: 6 and 12 months
description: Change of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome
measure: Quality-of-life questionnaire score
time frame: 6 and 12 months
description: Change of quality of life EuroQoL-5 Dimension Questionnaire(EQ-5D) Range 0-1.0(total score) low score worst outcome
measure: Work ability
time frame: 6 and 12 months
description: Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome
measure: Exhaustion
time frame: 6 and 12 months
description: Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome
arm group label: Intervention (Workplace dialogue)
arm group type: Experimental
description: Intervention: Work place convergence dialogue contact
arm group label: Care Manager
arm group type: Active Comparator
description: Intervention: Care Manager contact 12 weeks (Care as usual)
intervention type: Behavioral
intervention name: Workplace convergence dialogue
description: Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide
arm group label: Intervention (Workplace dialogue)
intervention type: Behavioral
intervention name: Care Manager
description: Regular contact Care Manager during around 12 weeks
arm group label: Care Manager
arm group label: Intervention (Workplace dialogue)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: No
last name: Cecilia Björkelund, prof
role: Principal Investigator
affiliation: Göteborg University
facility: 
country: Sweden
citation: Bjorkelund C, Saxvik A, Svenningsson I, Petersson EL, Wiegner L, Larsson M, Tornbom K, Wikberg C, Ariai N, Nejati S, Hensing G, Hange D. Rehabilitation cooperation and person-centred dialogue meeting for patients sick-listed for common mental disorders: 12 months follow-up of sick leave days, symptoms of depression, anxiety, stress and work ability - a pragmatic cluster randomised controlled trial from the CO-WORK-CARE project. BMJ Open. 2023 Jun 9;13(6):e074137. doi: 10.1136/bmjopen-2023-074137.
PMID: 37295824
citation: Svenningsson I, Bjorkelund C, Hange D, Wiegner L, Ariai N, Petersson EL. Symptom patterns in patients newly sick listed for common mental disorders and associations with work-related and socioeconomic factors: a cross-sectional study in Swedish primary care. BMJ Open. 2022 Jul 8;12(7):e054250. doi: 10.1136/bmjopen-2021-054250.
PMID: 35803640
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
sharing ipd: Yes
ipd description: De-identified data of individual participants will be made available to other researchers, provided reasonable request by personal contact, as soon as publication of results is effected.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available after 12 months after study completion/ alternatively as soon as publication of results is effected.
ipd access criteria: Data access will be reviewed by an external independent review panel.