<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/NCT03240913</url>
  </required_header>
  <id_info>
    <org_study_id>REB16-0869</org_study_id>
    <nct_id>NCT03240913</nct_id>
  </id_info>
  <brief_title>A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty</brief_title>
  <official_title>A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</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 primary objectives of this study are to: 1) develop an educational tool known as the&#xD;
      Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the&#xD;
      options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine&#xD;
      what to expect if they choose either option; 2) assess the extent that the PROM-DA improves&#xD;
      patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA&#xD;
      in multiple sites and more patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">March 3, 2020</completion_date>
  <primary_completion_date type="Actual">October 18, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decision quality</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>Hip and Knee Decision Quality Instrument (HK-DQI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (generic)</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>Euroqol Five Dimensions Questionnaire (EQ-5D-5L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (condition-specific)</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>The Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge about total knee arthroplasty surgery</measure>
    <time_frame>Baseline</time_frame>
    <description>HK-DQI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Values</measure>
    <time_frame>Baseline</time_frame>
    <description>HK-DQI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional conflict</measure>
    <time_frame>Baseline</time_frame>
    <description>Decisional Conflict Scale (SURE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Preference</measure>
    <time_frame>Baseline</time_frame>
    <description>Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks?&#xD;
Yes No Unsure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preference for involvement in decision making</measure>
    <time_frame>Baseline</time_frame>
    <description>Control Preferences Scale (CPS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to have surgery</measure>
    <time_frame>Baseline</time_frame>
    <description>Single item question: Based on your current understanding of the risks and benefits of knee replacement surgery of your knee arthritis, what is your current preference between having joint replacement surgery or non-surgical treatments?&#xD;
I would definitely consider having knee joint replacement surgery now. I would probably consider having knee joint replacement surgery now. I am not sure. I would probably not consider having knee joint replacement surgery now. I would definitely not consider having knee joint replacement surgery now.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported shared decision-making</measure>
    <time_frame>3 to 6 weeks after baseline</time_frame>
    <description>CollaboRATE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional regret</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>Decision Regret Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with knee replacement surgery</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>Three item questionnaire:&#xD;
Overall, how satisfied are you with the results of your knee replacement surgery?&#xD;
How satisfied are you with your knee replacement surgery for reducing your pain when walking on a flat surface? Going up or down stairs? Sitting or lying down?&#xD;
How satisfied are you with your most recent knee replacement surgery for improving your ability to perform five functions: Going up stairs? Getting in/out of a car or on/off a bus? Rising from bed? Lying in bed? Performing light domestic duties?&#xD;
Responses from 'very dissatisfied' to ' very satisfied'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expectations</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>Single item question from Bourne et al. 2010. Clin Orthop Relat Res. related to whether expectations were met; not met; or whether they had no expectations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical consult</measure>
    <time_frame>1 to 4 weeks after baseline</time_frame>
    <description>Electronic Medical Records (EMR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgery</measure>
    <time_frame>27 to 30 weeks after baseline</time_frame>
    <description>EMR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance</measure>
    <time_frame>40 to 52 weeks after baseline</time_frame>
    <description>HK-DQI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Treatment Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional information</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Baseline and Follow-up Surveys</intervention_name>
    <description>(completed online)</description>
    <arm_group_label>Non Treatment Group</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Reported Outcome Measure informed Decision Aid</intervention_name>
    <description>(PROM-DA)</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pamphlet</intervention_name>
    <description>(usual care)</description>
    <arm_group_label>Non Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (age≥30) patients with knee osteoarthritis (OA)&#xD;
&#xD;
          -  Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at&#xD;
             the Edmonton Bone and Joint Centre&#xD;
&#xD;
          -  Understands, speaks and reads English; and&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who have had prior total knee arthroplasty&#xD;
&#xD;
          -  Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis,&#xD;
             Fibromyalgia, or Gout.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Edmonton Bone and Joint Centre</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5E 5R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03240913
org study id: REB16-0869
nct id: NCT03240913
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objectives of this study are to: 1) develop an educational tool known as the
      Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the
      options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine
      what to expect if they choose either option; 2) assess the extent that the PROM-DA improves
      patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA
      in multiple sites and more patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Decision quality
time frame: 40 to 52 weeks after baseline
description: Hip and Knee Decision Quality Instrument (HK-DQI)
measure: Quality of life (generic)
time frame: 40 to 52 weeks after baseline
description: Euroqol Five Dimensions Questionnaire (EQ-5D-5L)
measure: Quality of life (condition-specific)
time frame: 40 to 52 weeks after baseline
description: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
measure: Depression
time frame: 40 to 52 weeks after baseline
description: The Patient Health Questionnaire (PHQ-9)
measure: Knowledge about total knee arthroplasty surgery
time frame: Baseline
description: HK-DQI
measure: Values
time frame: Baseline
description: HK-DQI
measure: Decisional conflict
time frame: Baseline
description: Decisional Conflict Scale (SURE)
measure: Treatment Preference
time frame: Baseline
description: Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks?
Yes No Unsure
measure: Preference for involvement in decision making
time frame: Baseline
description: Control Preferences Scale (CPS)
measure: Willingness to have surgery
time frame: Baseline
description: Single item question: Based on your current understanding of the risks and benefits of knee replacement surgery of your knee arthritis, what is your current preference between having joint replacement surgery or non-surgical treatments?
I would definitely consider having knee joint replacement surgery now. I would probably consider having knee joint replacement surgery now. I am not sure. I would probably not consider having knee joint replacement surgery now. I would definitely not consider having knee joint replacement surgery now.
measure: Patient-reported shared decision-making
time frame: 3 to 6 weeks after baseline
description: CollaboRATE
measure: Decisional regret
time frame: 40 to 52 weeks after baseline
description: Decision Regret Scale
measure: Satisfaction with knee replacement surgery
time frame: 40 to 52 weeks after baseline
description: Three item questionnaire:
Overall, how satisfied are you with the results of your knee replacement surgery?
How satisfied are you with your knee replacement surgery for reducing your pain when walking on a flat surface? Going up or down stairs? Sitting or lying down?
How satisfied are you with your most recent knee replacement surgery for improving your ability to perform five functions: Going up stairs? Getting in/out of a car or on/off a bus? Rising from bed? Lying in bed? Performing light domestic duties?
Responses from 'very dissatisfied' to ' very satisfied'
measure: Expectations
time frame: 40 to 52 weeks after baseline
description: Single item question from Bourne et al. 2010. Clin Orthop Relat Res. related to whether expectations were met; not met; or whether they had no expectations.
measure: Surgical consult
time frame: 1 to 4 weeks after baseline
description: Electronic Medical Records (EMR)
measure: Surgery
time frame: 27 to 30 weeks after baseline
description: EMR
measure: Concordance
time frame: 40 to 52 weeks after baseline
description: HK-DQI
arm group label: Treatment Group
arm group type: Experimental
arm group label: Non Treatment Group
arm group type: Placebo Comparator
description: Conventional information
intervention type: Behavioral
intervention name: Baseline and Follow-up Surveys
description: (completed online)
arm group label: Non Treatment Group
arm group label: Treatment Group
intervention type: Other
intervention name: Patient Reported Outcome Measure informed Decision Aid
description: (PROM-DA)
arm group label: Treatment Group
intervention type: Other
intervention name: Pamphlet
description: (usual care)
arm group label: Non Treatment Group
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No