<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/NCT03004989</url>
  </required_header>
  <id_info>
    <org_study_id>2012/7266 UiO</org_study_id>
    <nct_id>NCT03004989</nct_id>
  </id_info>
  <brief_title>Experiences of Participating in Return to Work Group Programmes</brief_title>
  <acronym>RTW-GP</acronym>
  <official_title>Experiences of Participating in Return to Work Group Programmes for People With Musculoskeletal Disorders: A Focus Group Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revmatismesykehuset AS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South-Eastern Norway Regional Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Revmatismesykehuset AS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have&#xD;
      participated in return-to-work group programmes (RTW-GPs) and see how the programmes could&#xD;
      strengthen their work ability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For a representative sampling of experiences, participants who had participated in various&#xD;
      groups over time in outpatient and inpatient groups in the RTW-GP were invited to enrol in&#xD;
      the study. Other inclusion criteria were age between 25 and 65 years, different&#xD;
      musculoskeletal diagnosis and that they should come from the rural district/city of&#xD;
      residence.&#xD;
&#xD;
      The participants received requests by letter to participate in the focus group interview six&#xD;
      months after the final group intervention, the same time as they were invited to a follow-up&#xD;
      visit. Only a few men had participated in the RTW-GPs and none of them wanted to take part in&#xD;
      the study.&#xD;
&#xD;
      All participants were given written and oral information about the study, the use of&#xD;
      recording and transcribing devices, and their right to withdraw from the study at any time.&#xD;
      The interviews were carried out after the participants gave written, informed consent.&#xD;
&#xD;
      Three focus group interviews were conducted: one with six participants, and two with five.&#xD;
      One participant who could not participate in the focus group interview participated at an&#xD;
      individual interview with the same questions as in the focus groups. The individual interview&#xD;
      was conducted first and served as a test for the questions in the interview guide.&#xD;
&#xD;
      Interventions The participants of this study had participated in one of three different&#xD;
      RTW-GPs. These programmes are designed to enable participants to proactively take action in&#xD;
      their daily lives and in collaboration with employers achieve the best possible working&#xD;
      conditions. All the group sessions are based on cognitive theory where attention, awareness&#xD;
      and reflection on one's own work and life situation is important. Motivation is instilled by&#xD;
      helping participants recognise opportunities for change. Participants set work-related goals&#xD;
      and receive individual feedback from multidisciplinary personnel in addition to various&#xD;
      group-based sessions with teaching, activities and exercises. The participants are referred&#xD;
      to the programme by a rheumatologist or a member of the hospital's multidisciplinary team as&#xD;
      soon as possible after starting sick-leave.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient experiences after participating at RTW-GP</measure>
    <time_frame>May 2012 - November 2013</time_frame>
    <description>Focus group interviews</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>May 2012 - November 2013</time_frame>
    <description>Focus group interviews</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Work ability</measure>
    <time_frame>May 2012 - November 2013</time_frame>
    <description>Focus group interview</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Musculoskeletal Diseases or Conditions</condition>
  <arm_group>
    <arm_group_label>Programme 1</arm_group_label>
    <description>RTW group in day clinics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Programme 2</arm_group_label>
    <description>RTW group in day clinics for people with fibromyalgia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Programme 3</arm_group_label>
    <description>My work and I</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Programme</intervention_name>
    <description>The participants of this study had participated in one of three different RTW-GPs. These programmes are designed to enable participants to proactively take action in their daily lives and in collaboration with employers achieve the best possible working conditions. All the group sessions are based on cognitive theory where attention, awareness and reflection on one's own work and life situation is important</description>
    <arm_group_label>Programme 1</arm_group_label>
    <arm_group_label>Programme 2</arm_group_label>
    <arm_group_label>Programme 3</arm_group_label>
    <other_name>Programme 1</other_name>
    <other_name>Programme 2</other_name>
    <other_name>Programme 3</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 17 female informants participated in the study, age 28 - 57 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participating RTW-GP&#xD;
&#xD;
          -  Musculoskeletal diagnoses&#xD;
&#xD;
          -  From the rural district/city of residence&#xD;
&#xD;
          -  Speaking Norwegian&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>28 Years</minimum_age>
    <maximum_age>57 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bente Hamnes, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Revmatismesykehuset AS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Revmatismesykehuset</name>
      <address>
        <city>Lillehammer</city>
        <zip>2609</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Qualitative study</keyword>
  <keyword>Musculoskeletal Disorders</keyword>
  <keyword>Return to Work Programme</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03004989
org study id: 2012/7266 UiO
nct id: NCT03004989
lead sponsor: 
collaborator: 
has dmc: No
To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have
      participated in return-to-work group programmes (RTW-GPs) and see how the programmes could
      strengthen their work ability.
For a representative sampling of experiences, participants who had participated in various
      groups over time in outpatient and inpatient groups in the RTW-GP were invited to enrol in
      the study. Other inclusion criteria were age between 25 and 65 years, different
      musculoskeletal diagnosis and that they should come from the rural district/city of
      residence.

      The participants received requests by letter to participate in the focus group interview six
      months after the final group intervention, the same time as they were invited to a follow-up
      visit. Only a few men had participated in the RTW-GPs and none of them wanted to take part in
      the study.

      All participants were given written and oral information about the study, the use of
      recording and transcribing devices, and their right to withdraw from the study at any time.
      The interviews were carried out after the participants gave written, informed consent.

      Three focus group interviews were conducted: one with six participants, and two with five.
      One participant who could not participate in the focus group interview participated at an
      individual interview with the same questions as in the focus groups. The individual interview
      was conducted first and served as a test for the questions in the interview guide.

      Interventions The participants of this study had participated in one of three different
      RTW-GPs. These programmes are designed to enable participants to proactively take action in
      their daily lives and in collaboration with employers achieve the best possible working
      conditions. All the group sessions are based on cognitive theory where attention, awareness
      and reflection on one's own work and life situation is important. Motivation is instilled by
      helping participants recognise opportunities for change. Participants set work-related goals
      and receive individual feedback from multidisciplinary personnel in addition to various
      group-based sessions with teaching, activities and exercises. The participants are referred
      to the programme by a rheumatologist or a member of the hospital's multidisciplinary team as
      soon as possible after starting sick-leave.
time perspective: Retrospective
measure: Patient experiences after participating at RTW-GP
time frame: May 2012 - November 2013
description: Focus group interviews
measure: Quality of life
time frame: May 2012 - November 2013
description: Focus group interviews
measure: Work ability
time frame: May 2012 - November 2013
description: Focus group interview
arm group label: Programme 1
description: RTW group in day clinics
arm group label: Programme 2
description: RTW group in day clinics for people with fibromyalgia
arm group label: Programme 3
description: My work and I
intervention type: Behavioral
intervention name: Programme
description: The participants of this study had participated in one of three different RTW-GPs. These programmes are designed to enable participants to proactively take action in their daily lives and in collaboration with employers achieve the best possible working conditions. All the group sessions are based on cognitive theory where attention, awareness and reflection on one's own work and life situation is important
arm group label: Programme 1
arm group label: Programme 2
arm group label: Programme 3
other name: Programme 1
other name: Programme 2
other name: Programme 3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 28 Years
maximum age: 57 Years
healthy volunteers: No
last name: Bente Hamnes, PhD
role: Study Chair
affiliation: Revmatismesykehuset AS
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases
sharing ipd: No