<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/NCT03764982</url>
  </required_header>
  <id_info>
    <org_study_id>99008</org_study_id>
    <secondary_id>DS-00040</secondary_id>
    <nct_id>NCT03764982</nct_id>
  </id_info>
  <brief_title>RehabNytte- A Study of Rehabilitation Processes in Specialized Care in Norway</brief_title>
  <official_title>RehabNytte. A Multi Center Study in Specialized Rehabilitation Centers in Norway Exploring Health, Function, Workability and Quality of Life Following Rehabilitation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diakonhjemmet Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VIRKE Rehab</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian National Centre for Occupational Rehabilitation (NKARR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regional Center of Knowledge Translation in Rehabilitation, Sunnaas rehabilitation hosp.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Skogli Health and Rehabilitation Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stiftelsen CatoSenteret rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HLF Briskeby rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vikersund rehabilitation center and kurbad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Røysumtunet rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Evjeklinikken</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Montebellosenteret</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Muritunet as rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Røde Kors Haugland rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sørlandet rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AVONOVA Ringerike rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hernes institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NKS Helsehus as</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ravneberghaugen rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Åstveit rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Selli rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helsepartner rehabilitation center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian National Advisory Unit on Rehabilitation in Rheumatology (NKRR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Diakonhjemmet Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The main objective of the study is to describe function and health related to quality of life&#xD;
      during the first year after rehabilitation, to measure the degree and impact of user&#xD;
      involvement in the rehabilitation process, and to test measurement properties of a new core&#xD;
      set of outcome measures for rehabilitation launched by the Norwegian Directorate of Health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a large multicentre cohort study including patients receiving rehabilitation at 17&#xD;
      rehabilitation centres from Norway, *the RehabNytte Consortium. Invitation and registration&#xD;
      of participants will be conducted by local project coordinators in the period between&#xD;
      01.01.2019 and 31.03.2020.&#xD;
&#xD;
      All participants will receive rehabilitation as usual at each centre, and report HRQoL,&#xD;
      health and function (by PROMS) through a digital self-reporting system at admission,&#xD;
      discharge and after 3, 6 and 12 months.&#xD;
&#xD;
      This study seeks to answer several research questions related to the overarching areas:&#xD;
&#xD;
        1. Patient reported change of function, health and quality of life during the first year&#xD;
           after rehabilitation&#xD;
&#xD;
        2. Degree of user involvement in rehabilitation&#xD;
&#xD;
        3. Quality assessment (use of Quality indicator set)&#xD;
&#xD;
        4. Measurement characteristics (feasibility and responsiveness) of recommended PROMS in&#xD;
           rehabilitation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Actual">March 31, 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>The EuroQoL-5D-5L</measure>
    <time_frame>1-3 minutes</time_frame>
    <description>5-item questionnaire assessing function and health in walking, ADL, personal care, pain/discomfort and anxiety/depression. Sores could be calculated both as numbers and 'utilities'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The EuroQoL-VAS health</measure>
    <time_frame>1-2 minutes</time_frame>
    <description>The EUROQUOL 5D-5L includes a 100 mm VAS scale/thermometer. Index value: 0-1, 1 is best VAS gen health: 0-100, 100 is best</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Patient Specific Functional Scale (PSFS)</measure>
    <time_frame>2-6 minutes</time_frame>
    <description>Patient-specific instrument. Up to five activities are described by the patient, and scored according to experienced performance (0-10, 10 is best).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS 29</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities) with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity.</description>
  </primary_outcome>
  <other_outcome>
    <measure>The MUSS Quality Indicator set for Rehabilitation</measure>
    <time_frame>3-8 minutes</time_frame>
    <description>This Quality Indicator assessment tool consist of two separate questionnaires answered by rehabilitation managers and patients, and each questionnaire consist of 10 and 11 questions respectively. The quality indicators are originally developed for use in Rheumatic and musculoskeletal disorders (RMDs) has been developed and pilot tested according to the Rand/UCLA Appropriateness Method. In this study the set will be tested in a generic population.</description>
  </other_outcome>
  <enrollment type="Actual">3793</enrollment>
  <condition>Rehabilitation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        -  Patients receiving rehabilitation at seventeen rehabilitation centres in specialist&#xD;
             care (all health regions)&#xD;
&#xD;
          -  All diagnoses, with largest groups of musculoskeletal diseases, neurological&#xD;
             conditions (stroke, MS), cancer, and heart- and lunge conditions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients that participates in inpatient or outpatient rehabilitation programs at one&#xD;
             of the participating centers.&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Access to internet at home&#xD;
&#xD;
          -  Access to personal secure login with BANK ID.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severely reduced cognitive function&#xD;
&#xD;
          -  severe mental illness with inadequate consent competence ability to participate&#xD;
&#xD;
          -  Insufficient understanding of Norwegian written language.&#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>Tore K Kvien, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Dep.Rheumatology, Diakonhjemmet hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsepartner rehabilitation centre</name>
      <address>
        <city>Alta</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Åstveit rehabilitation centre</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sørlandet rehabilitation centre</name>
      <address>
        <city>Eiken</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evjeklinikken rehabilitation centre</name>
      <address>
        <city>Evje</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Red Cross Haugland rehabilitation centre</name>
      <address>
        <city>Flekke</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ravneberghaugen rehabilitation centre</name>
      <address>
        <city>Hagavik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hernes institutt</name>
      <address>
        <city>Hernes</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AVONOVA Ringerike rehabilitation centre</name>
      <address>
        <city>Hønefoss</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Røysumtunet rehabiliteringssenter</name>
      <address>
        <city>Jaren</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Selli rehabilitation centre</name>
      <address>
        <city>Klæbu</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HLF Briskeby rehabilitation centre</name>
      <address>
        <city>Lier</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montebellosenteret</name>
      <address>
        <city>Lillehammer</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skogli rehabilitation centre</name>
      <address>
        <city>Lillehammer</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NKS Helsehus</name>
      <address>
        <city>Lørenskog</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CatoSenteret</name>
      <address>
        <city>Son</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Muritunet rehabilitation centre</name>
      <address>
        <city>Valldal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vikersund rehabilitation centre</name>
      <address>
        <city>Vikersund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diakonhjemmet Hospital</investigator_affiliation>
    <investigator_full_name>Rikke Helene Moe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Multidisciplinary</keyword>
  <keyword>Health care</keyword>
  <keyword>*the RehabNytte Consortium</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Participating centres will have access to de-identificated IPD after the data collection period is completed. Data will only be shared with other researchers after approval by the steering committee, and in line with the purposes of the project.</ipd_description>
  </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/NCT03764982
org study id: 99008
secondary id: DS-00040
nct id: NCT03764982
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of the study is to describe function and health related to quality of life
      during the first year after rehabilitation, to measure the degree and impact of user
      involvement in the rehabilitation process, and to test measurement properties of a new core
      set of outcome measures for rehabilitation launched by the Norwegian Directorate of Health.
This is a large multicentre cohort study including patients receiving rehabilitation at 17
      rehabilitation centres from Norway, *the RehabNytte Consortium. Invitation and registration
      of participants will be conducted by local project coordinators in the period between
      01.01.2019 and 31.03.2020.

      All participants will receive rehabilitation as usual at each centre, and report HRQoL,
      health and function (by PROMS) through a digital self-reporting system at admission,
      discharge and after 3, 6 and 12 months.

      This study seeks to answer several research questions related to the overarching areas:

        1. Patient reported change of function, health and quality of life during the first year
           after rehabilitation

        2. Degree of user involvement in rehabilitation

        3. Quality assessment (use of Quality indicator set)

        4. Measurement characteristics (feasibility and responsiveness) of recommended PROMS in
           rehabilitation
observational model: Cohort
time perspective: Prospective
measure: The EuroQoL-5D-5L
time frame: 1-3 minutes
description: 5-item questionnaire assessing function and health in walking, ADL, personal care, pain/discomfort and anxiety/depression. Sores could be calculated both as numbers and 'utilities'.
measure: The EuroQoL-VAS health
time frame: 1-2 minutes
description: The EUROQUOL 5D-5L includes a 100 mm VAS scale/thermometer. Index value: 0-1, 1 is best VAS gen health: 0-100, 100 is best
measure: The Patient Specific Functional Scale (PSFS)
time frame: 2-6 minutes
description: Patient-specific instrument. Up to five activities are described by the patient, and scored according to experienced performance (0-10, 10 is best).
measure: PROMIS 29
time frame: 5-10 minutes
description: The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities) with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity.
measure: The MUSS Quality Indicator set for Rehabilitation
time frame: 3-8 minutes
description: This Quality Indicator assessment tool consist of two separate questionnaires answered by rehabilitation managers and patients, and each questionnaire consist of 10 and 11 questions respectively. The quality indicators are originally developed for use in Rheumatic and musculoskeletal disorders (RMDs) has been developed and pilot tested according to the Rand/UCLA Appropriateness Method. In this study the set will be tested in a generic population.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tore K Kvien, Professor
role: Study Director
affiliation: Dep.Rheumatology, Diakonhjemmet hospital
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country: Norway
responsible party type: Principal Investigator
investigator affiliation: Diakonhjemmet Hospital
investigator full name: Rikke Helene Moe
investigator title: Principal Investigator
sharing ipd: Undecided
ipd description: Participating centres will have access to de-identificated IPD after the data collection period is completed. Data will only be shared with other researchers after approval by the steering committee, and in line with the purposes of the project.