<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/NCT02974036</url>
  </required_header>
  <id_info>
    <org_study_id>782-14</org_study_id>
    <nct_id>NCT02974036</nct_id>
  </id_info>
  <brief_title>Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care</brief_title>
  <official_title>Patient Enablement in Osteoarthritis - a Longitudinal Study on Patient Education Programs in Primary Health Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose is to study quality in patient education by means of the patients'&#xD;
      self-rated enablement. Specific aims are:&#xD;
&#xD;
      To assess the validity of the patient enablement instrument in relation to self-efficacy and&#xD;
      empowerment; To investigate if patient enablement can be effective in identifying which&#xD;
      patients would benefit the most from patient education; To study if patient enablement has&#xD;
      any relation to self-efficacy, function or self-rated health; To analyze if patient&#xD;
      enablement has a causal effect on health care consumption; To evaluate whether patient&#xD;
      education is a cost-effective intervention. The project is a longitudinal study, including&#xD;
      patients from a patient education programme for osteoarthritis in primary health care. Data&#xD;
      consist of patient reported outcome measures and health care consumption. Cost-effectiveness&#xD;
      and cost-utility analysis will be used. Inclusion of patients will start August 2016.&#xD;
      Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included&#xD;
      are from primary health care settings and researchers in the field of OA, patient education&#xD;
      and health economy. Our increasingly older and more inactive population will raise huge&#xD;
      demands on the health care. The importance of optimizing treatments that are available in&#xD;
      primary health care cannot be underestimated. The project will contribute with important&#xD;
      knowledge about the patient's own process of getting well.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project is a longitudinal study, including patients who are referred to patient education&#xD;
      for osteoarthritis in primary health care and is planned to follow the patients one year&#xD;
      before baseline measures as well as one year after baseline measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">October 18, 2019</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>Patient enablement</measure>
    <time_frame>directly after intervention</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arthritis Self Efficacy Scale</measure>
    <time_frame>before intervention, directly after intervention and at 3 and 9 month follow up</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Swedish Rheumatic Empowerment Scale</measure>
    <time_frame>Before intervention, directly after intervention and at 3 and 9 month follow up</time_frame>
    <description>Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>EQ5D index</measure>
    <time_frame>Before intervention, directly after intervention and at 3 and 9 month follow up</time_frame>
    <description>Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Health care consumption</measure>
    <time_frame>12 months before baseline and 12 months after baseline</time_frame>
    <description>Linked register data from the Skåne Health Care Register</description>
  </other_outcome>
  <other_outcome>
    <measure>Sick leave</measure>
    <time_frame>12 months before baseline and 12 months after baseline</time_frame>
    <description>Linked register data from the Swedish Social Insurance Agency</description>
  </other_outcome>
  <other_outcome>
    <measure>EQ5D Health barometer</measure>
    <time_frame>Before intervention, directly after intervention and at 3 and 9 month follow up</time_frame>
    <description>visual analogue scale</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">143</enrollment>
  <condition>Patient Education as Topic</condition>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Patient education for osteoarthritis</arm_group_label>
    <description>The intervention in the education program consists of three group lessons of about 90 minutes each where information about ethiology, risk factors, treatment and coping strategies concerning OA is included. The first two lessons are held by a physiotherapist and the third by a so-called expert patient that is a person with OA who shares his or her experiences of how to live with the disease. After the intervention patients are able to choose if they want to exercise at home or in a group, supervised by a physiotherapist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient education for osteoarthritis</intervention_name>
    <description>Group sessions and optional supervised exercise.</description>
    <arm_group_label>Patient education for osteoarthritis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are referred to patient education for OA in primary health care&#xD;
&#xD;
          -  Speaks and write Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not having OA&#xD;
&#xD;
          -  Not able to speak or write Swedish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Ekvall Hansson, Ass prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Health Care</name>
      <address>
        <city>Malmo</city>
        <zip>SE20502</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://boa.registercentrum.se/</url>
    <description>BOA registry</description>
  </link>
  <reference>
    <citation>Hansson EE, Jonsson-Lundgren M, Ronnheden AM, Sorensson E, Bjarnung A, Dahlberg LE. Effect of an education programme for patients with osteoarthritis in primary care--a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:244. doi: 10.1186/1471-2474-11-244.</citation>
    <PMID>20969809</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>February 25, 2022</last_update_submitted>
  <last_update_submitted_qc>February 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Eva Ekvall-Hansson</investigator_full_name>
    <investigator_title>Senior lecturer, associate professor</investigator_title>
  </responsible_party>
  <keyword>Patient education</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Primary health care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02974036
org study id: 782-14
nct id: NCT02974036
lead sponsor: 
has dmc: No
The overall purpose is to study quality in patient education by means of the patients'
      self-rated enablement. Specific aims are:

      To assess the validity of the patient enablement instrument in relation to self-efficacy and
      empowerment; To investigate if patient enablement can be effective in identifying which
      patients would benefit the most from patient education; To study if patient enablement has
      any relation to self-efficacy, function or self-rated health; To analyze if patient
      enablement has a causal effect on health care consumption; To evaluate whether patient
      education is a cost-effective intervention. The project is a longitudinal study, including
      patients from a patient education programme for osteoarthritis in primary health care. Data
      consist of patient reported outcome measures and health care consumption. Cost-effectiveness
      and cost-utility analysis will be used. Inclusion of patients will start August 2016.
      Analyses of data and manuscript writing will be performed in 2018-2019. Researchers included
      are from primary health care settings and researchers in the field of OA, patient education
      and health economy. Our increasingly older and more inactive population will raise huge
      demands on the health care. The importance of optimizing treatments that are available in
      primary health care cannot be underestimated. The project will contribute with important
      knowledge about the patient's own process of getting well.
The project is a longitudinal study, including patients who are referred to patient education
      for osteoarthritis in primary health care and is planned to follow the patients one year
      before baseline measures as well as one year after baseline measures.
observational model: Cohort
time perspective: Prospective
measure: Patient enablement
time frame: directly after intervention
description: Questionnaire
measure: Arthritis Self Efficacy Scale
time frame: before intervention, directly after intervention and at 3 and 9 month follow up
description: Questionnaire
measure: Swedish Rheumatic Empowerment Scale
time frame: Before intervention, directly after intervention and at 3 and 9 month follow up
description: Questionnaire
measure: EQ5D index
time frame: Before intervention, directly after intervention and at 3 and 9 month follow up
description: Questionnaire
measure: Health care consumption
time frame: 12 months before baseline and 12 months after baseline
description: Linked register data from the Skåne Health Care Register
measure: Sick leave
time frame: 12 months before baseline and 12 months after baseline
description: Linked register data from the Swedish Social Insurance Agency
measure: EQ5D Health barometer
time frame: Before intervention, directly after intervention and at 3 and 9 month follow up
description: visual analogue scale
arm group label: Patient education for osteoarthritis
description: The intervention in the education program consists of three group lessons of about 90 minutes each where information about ethiology, risk factors, treatment and coping strategies concerning OA is included. The first two lessons are held by a physiotherapist and the third by a so-called expert patient that is a person with OA who shares his or her experiences of how to live with the disease. After the intervention patients are able to choose if they want to exercise at home or in a group, supervised by a physiotherapist.
intervention type: Other
intervention name: Patient education for osteoarthritis
description: Group sessions and optional supervised exercise.
arm group label: Patient education for osteoarthritis
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eva Ekvall Hansson, Ass prof
role: Principal Investigator
affiliation: Lund University
facility: 
country: Sweden
url: https://boa.registercentrum.se/
description: BOA registry
citation: Hansson EE, Jonsson-Lundgren M, Ronnheden AM, Sorensson E, Bjarnung A, Dahlberg LE. Effect of an education programme for patients with osteoarthritis in primary care--a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:244. doi: 10.1186/1471-2474-11-244.
PMID: 20969809
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Eva Ekvall-Hansson
investigator title: Senior lecturer, associate professor
mesh term: Osteoarthritis
sharing ipd: Undecided