<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/NCT03752281</url>
  </required_header>
  <id_info>
    <org_study_id>TU-001-1811</org_study_id>
    <nct_id>NCT03752281</nct_id>
  </id_info>
  <brief_title>Long Term Social Assistance Recipient in South Eastern Sweden - a Description of Health, Function, and Activity</brief_title>
  <official_title>Long Term Social Assistance Receipt - An Observational Study of Health, Function, and Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Linkoeping Municipality</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a group of social assistance recipients which have difficulties in entering the&#xD;
      labor market and thus remains in a long-term dependency on social assistance. More knowledge&#xD;
      about individuals receiving long-term social assistance is needed in order to improve into&#xD;
      work interventions for this group. Therefore, this study aims to describe variables of&#xD;
      health, function and activity in participants receiving long-term social assistance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a group of social assistance recipients who have difficulties in entering the labor&#xD;
      market and thus remains in a long-term dependency on social assistance. More knowledge about&#xD;
      individuals receiving long-term social assistance is needed in order to improve into-work&#xD;
      interventions for this group. Therefore, this study aims to describe variables of health,&#xD;
      function and activity in participants receiving long-term social assistance. Individuals who&#xD;
      have received social assistance during more than three years, who report physical and/or&#xD;
      psychological difficulties, and/or have a complex social situation will be asked for&#xD;
      participation in a six months activity-based investigation including contact with social&#xD;
      worker, psychologist, occupational therapist, physical therapist and labor market consultant.&#xD;
      The intervention aims to clarify the participants hinders and resources for entering the&#xD;
      labor market. The participants are going to answer a questionnaire about health, function,&#xD;
      and activity before and after the investigation. In addition, the participants function and&#xD;
      ability to perform activities will be classified using the International Classification of&#xD;
      Functioning (ICF). Data from the questionnaires and from ICF recordings will be used to&#xD;
      describe variables of health, function and ability to be active. Participants who manage to&#xD;
      get closer to, or enter into, the labor market will be asked to participate in a qualitative&#xD;
      interview study about the experiences of the change. In addition, social workers will be&#xD;
      asked to participate in focus-group interviews about experiences from the professional&#xD;
      contact and work with the participants. The quantitative data will be analysed using&#xD;
      traditional statistics and multivariate data analysis. Qualitative data will be analysed&#xD;
      using qualitative content analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Change in quality of life</measure>
    <time_frame>Change between the beginning and the end of the six months intervention</time_frame>
    <description>The change in participants self-rated experience of quality of life is going to be described using EuroQol 5 Dimensions which contains a rating of the ability to perform activities, and also a score of the total quality of life experience.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-rated function and ability to be active</measure>
    <time_frame>Change between the beginning and the end of the six months intervention</time_frame>
    <description>The change in participants self-rated function and ability to be active is going to be described using the World Health Organisation Disability Assessment Schedule (WHODAS) which contains five-grade ratings of factors including functioning, activity and participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in objective description of function and ability to be active</measure>
    <time_frame>Change between the beginning and the end of the six months intervention</time_frame>
    <description>The change in an objective classification of function, activity, participation and environmental factors affecting disability will be described according to the International Classification of Functioning (ICF) in the beginning and at the end of the six month intervention. The ICF contains a number of components, where each component can be scored using a five-grade scale to clarify the magnitude of disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative description of experiences about an increase in activity ability</measure>
    <time_frame>After the six moths intervention</time_frame>
    <description>Participants experiences about a change towards higher ability to be active will be described using qualitative interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative description of social workers experiences from the work with long-term social assistance recipients</measure>
    <time_frame>After the six moths intervention</time_frame>
    <description>Social workers experiences from their work with helping clients to get closer to the labor market will be described using qualitative interviews.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Vocational Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Health and activity</arm_group_label>
    <description>The cohort consists of long-term social assistance recipients where there is need to investigate the health status and working ability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Investigation of health and activity</intervention_name>
    <description>During a six months multidisciplinary investigation of health status, activity and working ability for individuals receiving long-term social assistance, the health and activity status as well as function will be described using established questionnaires and the International Classification of Functioning</description>
    <arm_group_label>Health and activity</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who have been social assistance recipients for at least three years and who not&#xD;
        have a plan how to get closer to the labor market. There may be signs of different kinds of&#xD;
        ill-health such as physical, pshychological and/or social ill-health. The social worker&#xD;
        responsible for decision about the monetary support identifies a need for establishing the&#xD;
        working ability of the individual with the aim to agree on a plan towards self-sufficiency.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Long-term social assistance recipient (more than three years)&#xD;
&#xD;
          -  Putative ill-health (physical, psychological and/or social)&#xD;
&#xD;
          -  No present plan how to reach the labor market&#xD;
&#xD;
          -  Need of clarifying the working ability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Homelessness&#xD;
&#xD;
          -  Severe psychiatric illness&#xD;
&#xD;
          -  Abuse of alcohol or substances&#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>Linn Karlsson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Linkoeping Municipality, Linkoeping University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Linn Karlsson, PhD</last_name>
    <phone>+46 13206675</phone>
    <email>linn.b.karlsson@linkoping.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Health Sciences, Linköping University</name>
      <address>
        <city>Linköping</city>
        <state>Östergötland</state>
        <zip>SE 581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://www.socialstyrelsen.se/</url>
    <description>The national board of health and welfare in Sweden</description>
  </link>
  <link>
    <url>http://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/socialtjanstlag-2001453_sfs-2001-453</url>
    <description>The social service act</description>
  </link>
  <reference>
    <citation>van Vilsteren M, van Oostrom SH, de Vet HC, Franche RL, Boot CR, Anema JR. Workplace interventions to prevent work disability in workers on sick leave. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD006955. doi: 10.1002/14651858.CD006955.pub3.</citation>
    <PMID>26436959</PMID>
  </reference>
  <reference>
    <citation>Vogel N, Schandelmaier S, Zumbrunn T, Ebrahim S, de Boer WE, Busse JW, Kunz R. Return-to-work coordination programmes for improving return to work in workers on sick leave. Cochrane Database Syst Rev. 2017 Mar 30;3(3):CD011618. doi: 10.1002/14651858.CD011618.pub2.</citation>
    <PMID>28358173</PMID>
  </reference>
  <reference>
    <citation>Arends I, Bruinvels DJ, Rebergen DS, Nieuwenhuijsen K, Madan I, Neumeyer-Gromen A, Bultmann U, Verbeek JH. Interventions to facilitate return to work in adults with adjustment disorders. Cochrane Database Syst Rev. 2012 Dec 12;12:CD006389. doi: 10.1002/14651858.CD006389.pub2.</citation>
    <PMID>23235630</PMID>
  </reference>
  <reference>
    <citation>Madden RH, Dune T, Lukersmith S, Hartley S, Kuipers P, Gargett A, Llewellyn G. The relevance of the International Classification of Functioning, Disability and Health (ICF) in monitoring and evaluating Community-based Rehabilitation (CBR). Disabil Rehabil. 2014;36(10):826-37. doi: 10.3109/09638288.2013.821182. Epub 2013 Aug 14.</citation>
    <PMID>23944180</PMID>
  </reference>
  <reference>
    <citation>Prodinger B, Stucki G, Coenen M, Tennant A. The measurement of functioning using the International Classification of Functioning, Disability and Health: comparing qualifier ratings with existing health status instruments. Disabil Rehabil. 2019 Mar;41(5):541-548. doi: 10.1080/09638288.2017.1381186. Epub 2017 Oct 8.</citation>
    <PMID>28988490</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Bjorn Gerdle</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Health, activity, function and long-term social assistance</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The co-authors will have access to the underlying interview data for the qualitative analysis. Quantitative data will be coded and not able to identify to any participant for the co-authors. However, it may be necessary for the co-authors to get access to the quantitative (anonymized) raw data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The data will become available during analysis and manuscript writing. Probable for about six moths per paper.</ipd_time_frame>
    <ipd_access_criteria>Co-authors who will be participating in analysis and manuscript preparation.</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/NCT03752281
org study id: TU-001-1811
nct id: NCT03752281
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
There is a group of social assistance recipients which have difficulties in entering the
      labor market and thus remains in a long-term dependency on social assistance. More knowledge
      about individuals receiving long-term social assistance is needed in order to improve into
      work interventions for this group. Therefore, this study aims to describe variables of
      health, function and activity in participants receiving long-term social assistance.
There is a group of social assistance recipients who have difficulties in entering the labor
      market and thus remains in a long-term dependency on social assistance. More knowledge about
      individuals receiving long-term social assistance is needed in order to improve into-work
      interventions for this group. Therefore, this study aims to describe variables of health,
      function and activity in participants receiving long-term social assistance. Individuals who
      have received social assistance during more than three years, who report physical and/or
      psychological difficulties, and/or have a complex social situation will be asked for
      participation in a six months activity-based investigation including contact with social
      worker, psychologist, occupational therapist, physical therapist and labor market consultant.
      The intervention aims to clarify the participants hinders and resources for entering the
      labor market. The participants are going to answer a questionnaire about health, function,
      and activity before and after the investigation. In addition, the participants function and
      ability to perform activities will be classified using the International Classification of
      Functioning (ICF). Data from the questionnaires and from ICF recordings will be used to
      describe variables of health, function and ability to be active. Participants who manage to
      get closer to, or enter into, the labor market will be asked to participate in a qualitative
      interview study about the experiences of the change. In addition, social workers will be
      asked to participate in focus-group interviews about experiences from the professional
      contact and work with the participants. The quantitative data will be analysed using
      traditional statistics and multivariate data analysis. Qualitative data will be analysed
      using qualitative content analysis.
observational model: Cohort
time perspective: Prospective
measure: Change in quality of life
time frame: Change between the beginning and the end of the six months intervention
description: The change in participants self-rated experience of quality of life is going to be described using EuroQol 5 Dimensions which contains a rating of the ability to perform activities, and also a score of the total quality of life experience.
measure: Change in self-rated function and ability to be active
time frame: Change between the beginning and the end of the six months intervention
description: The change in participants self-rated function and ability to be active is going to be described using the World Health Organisation Disability Assessment Schedule (WHODAS) which contains five-grade ratings of factors including functioning, activity and participation.
measure: Change in objective description of function and ability to be active
time frame: Change between the beginning and the end of the six months intervention
description: The change in an objective classification of function, activity, participation and environmental factors affecting disability will be described according to the International Classification of Functioning (ICF) in the beginning and at the end of the six month intervention. The ICF contains a number of components, where each component can be scored using a five-grade scale to clarify the magnitude of disability.
measure: Qualitative description of experiences about an increase in activity ability
time frame: After the six moths intervention
description: Participants experiences about a change towards higher ability to be active will be described using qualitative interviews.
measure: Qualitative description of social workers experiences from the work with long-term social assistance recipients
time frame: After the six moths intervention
description: Social workers experiences from their work with helping clients to get closer to the labor market will be described using qualitative interviews.
arm group label: Health and activity
description: The cohort consists of long-term social assistance recipients where there is need to investigate the health status and working ability.
intervention type: Other
intervention name: Investigation of health and activity
description: During a six months multidisciplinary investigation of health status, activity and working ability for individuals receiving long-term social assistance, the health and activity status as well as function will be described using established questionnaires and the International Classification of Functioning
arm group label: Health and activity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Linn Karlsson, PhD
role: Study Chair
affiliation: Linkoeping Municipality, Linkoeping University
last name: Linn Karlsson, PhD
phone: +46 13206675
email: linn.b.karlsson@linkoping.se
facility: 
country: Sweden
url: http://www.socialstyrelsen.se/
description: The national board of health and welfare in Sweden
url: http://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/socialtjanstlag-2001453_sfs-2001-453
description: The social service act
citation: van Vilsteren M, van Oostrom SH, de Vet HC, Franche RL, Boot CR, Anema JR. Workplace interventions to prevent work disability in workers on sick leave. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD006955. doi: 10.1002/14651858.CD006955.pub3.
PMID: 26436959
citation: Vogel N, Schandelmaier S, Zumbrunn T, Ebrahim S, de Boer WE, Busse JW, Kunz R. Return-to-work coordination programmes for improving return to work in workers on sick leave. Cochrane Database Syst Rev. 2017 Mar 30;3(3):CD011618. doi: 10.1002/14651858.CD011618.pub2.
PMID: 28358173
citation: Arends I, Bruinvels DJ, Rebergen DS, Nieuwenhuijsen K, Madan I, Neumeyer-Gromen A, Bultmann U, Verbeek JH. Interventions to facilitate return to work in adults with adjustment disorders. Cochrane Database Syst Rev. 2012 Dec 12;12:CD006389. doi: 10.1002/14651858.CD006389.pub2.
PMID: 23235630
citation: Madden RH, Dune T, Lukersmith S, Hartley S, Kuipers P, Gargett A, Llewellyn G. The relevance of the International Classification of Functioning, Disability and Health (ICF) in monitoring and evaluating Community-based Rehabilitation (CBR). Disabil Rehabil. 2014;36(10):826-37. doi: 10.3109/09638288.2013.821182. Epub 2013 Aug 14.
PMID: 23944180
citation: Prodinger B, Stucki G, Coenen M, Tennant A. The measurement of functioning using the International Classification of Functioning, Disability and Health: comparing qualifier ratings with existing health status instruments. Disabil Rehabil. 2019 Mar;41(5):541-548. doi: 10.1080/09638288.2017.1381186. Epub 2017 Oct 8.
PMID: 28988490
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Bjorn Gerdle
investigator title: Professor
sharing ipd: Yes
ipd description: The co-authors will have access to the underlying interview data for the qualitative analysis. Quantitative data will be coded and not able to identify to any participant for the co-authors. However, it may be necessary for the co-authors to get access to the quantitative (anonymized) raw data.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The data will become available during analysis and manuscript writing. Probable for about six moths per paper.
ipd access criteria: Co-authors who will be participating in analysis and manuscript preparation.