<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/NCT01732562</url>
  </required_header>
  <id_info>
    <org_study_id>103027</org_study_id>
    <nct_id>NCT01732562</nct_id>
  </id_info>
  <brief_title>A Trial to Establish Realistic Patient Expectations of Total Knee Replacement</brief_title>
  <official_title>A Randomized Controlled Trial to Establish Realistic Patient Expectations of Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Orthopaedic Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients from the Joint Replacement Institute scheduled to undergo primary total knee&#xD;
      replacement surgery (TKR) will be invited to participate at the Pre Admission Clinic (PAC),&#xD;
      University Hospital, London Health Sciences Centre. Baseline questionnaires of preoperative&#xD;
      measures and demographic information and a cost analysis will be explored at the PAC for each&#xD;
      patient. Patients will be randomized with the treatment group receiving access to a&#xD;
      web-based, e-learning intervention. Postoperatively all patients will be asked to complete&#xD;
      questionnaires at 6 weeks, 3 months and 1 year after their TKR surgery.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      The first primary objective is to compare the effect of two methods of providing patient&#xD;
      education on expectations of surgical outcome in total knee replacement (TKR) patients.&#xD;
&#xD;
      The second objective is to compare the effect of two methods of providing patient education&#xD;
      on satisfaction with surgical outcome in TKR patients.&#xD;
&#xD;
      The intervention of interest is an e-learning education program that spans both the&#xD;
      preoperative and postoperative time period. The control condition will be the current method&#xD;
      of patient education provided at the hospital study site.&#xD;
&#xD;
      Hypothesis: Objective One&#xD;
&#xD;
      More change in patient expectations will occur between preoperative and one year&#xD;
      postoperative in the e-learning educational intervention group.&#xD;
&#xD;
      Hypothesis: Objective Two&#xD;
&#xD;
      More change in patient satisfaction will occur between preoperative and one year&#xD;
      postoperative in the e-learning educational intervention group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single centre prospective experimental study, involving seven orthopaedic&#xD;
      surgeons and their patients undergoing total knee replacement (TKR). A consecutive sample of&#xD;
      elective primary TKR patients will be invited to participate from London Health Sciences&#xD;
      Centre, University Hospital, London, Ontario, Canada. Additionally, patient hospital charts&#xD;
      will be accessed to establish the concordance between co-morbidities recorded in patient&#xD;
      history and self-report measures of co-morbidities.&#xD;
&#xD;
      Interested patients will be randomized into one of two groups. Group 1 (intervention) will&#xD;
      receive the e-learning educational intervention in addition to the current method of patient&#xD;
      education. It will commence at the pre-admission clinic and continue to the study end-point&#xD;
      of 1-year postoperative. Group 2 (control) will receive the current, existing method utilized&#xD;
      by each of the seven orthopaedic surgeons for their patient education. At pre-admission,&#xD;
      patients are provided a 31 page hard copy of My Guide to Total Knee Joint Replacement&#xD;
      (Revised January, 2008) and they are made aware of an electronic copy of this document&#xD;
      available at the following website: http://www.jointreplacementinstitute.com/patients.html&#xD;
&#xD;
      The assumption is that patients can and will read this document to educate themselves about&#xD;
      their TKR surgery. The interactive e-learning patient education intervention extends beyond&#xD;
      simple accessibility to information and includes interactive features. The intervention spans&#xD;
      surgery and rehabilitation aftercare with patients undergoing TKR. Measurements will take&#xD;
      place at pre-admission before any preoperative education takes place and at 6 weeks, 3 months&#xD;
      and 1 year after TKR surgery. Patients will have the option of completing questionnaires&#xD;
      online using Empower or hard copy sent by mail. They will also receive reminders by email or&#xD;
      phone about completing the questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Expectations</measure>
    <time_frame>Change in Patient Expectations from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
    <description>Patient Expectations will be measured with four distinct domains using single questions related to pain; ability to perform activities of daily living (ADL); ability to participate in sports and global recovery from surgery. Responses are given using a 0 to four scale, with 0 assigned for a not applicable response option: 1= no, I do not expect surgery to help with my pain/ADL/etc., 2= yes, but just a little, 3= yes, somewhat, 4= yes, a lot.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Change in Patient Satisfaction from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
    <description>Patient Satisfaction will be measured using the Patient Acceptable Symptom State Question (PASS). This question will be, &quot;Considering all the activities you do during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?&quot; The response options to this question are simply 'yes' or 'no'.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Knee Society Score: Pre-Op</measure>
    <time_frame>Change in Knee Society Score: Pre-Op from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Change in KOOS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Short Form-12 (SF-12) Health Survey</measure>
    <time_frame>Change in SF-12 from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Change in HADS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Change in PCS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Self-Administered Comorbidity Questionnaire (SCQ)</measure>
    <time_frame>Baseline measure taken the Pre-Admission Clinic (PAC) visit only.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>University of California at Los Angeles (UCLA) Activity Score</measure>
    <time_frame>Change in UCLA Activity Score from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Social Role Participation Questionnaire (SRPQ)</measure>
    <time_frame>Change in SRPQ from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">416</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient receives the standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient e-Learning educational tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient receives the standard of care and access to patient e-Learning educational tool.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient e-Learning educational tool</intervention_name>
    <description>Web based site with videos of TKR surgical animation, demonstrations of exercises and activities following surgery and conversations with surgeons, physiotherapist, occupational therapist and patients.</description>
    <arm_group_label>Patient e-Learning educational tool</arm_group_label>
    <other_name>NewKnees.ca</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-90 years of age&#xD;
&#xD;
          -  diagnosis of primary or secondary osteoarthritis of the knee&#xD;
&#xD;
          -  scheduled for primary total knee replacement by Joint Replacement Institute&#xD;
             orthopaedic surgeons at University Hospital, London Health Sciences Centre&#xD;
&#xD;
          -  access to a computer (to log on to the web-based e-learning intervention)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to read written English or understand spoken English&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
&#xD;
          -  diagnosis of rheumatoid arthritis&#xD;
&#xD;
          -  scheduled for knee revision, patellar resurfacing, hemiarthroplasty of the knee,&#xD;
             unicompartmental (unicondylar) knee arthroplasty or high tibial osteotomy, or knee&#xD;
             surgery due to a tumor or trauma&#xD;
&#xD;
          -  unable to access a computer (to log on to the web-based e-learning intervention)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bert M Chesworth, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Western Ontario</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre, University hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>August 8, 2016</last_update_submitted>
  <last_update_submitted_qc>August 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Bert Chesworth</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Primary Total Knee Arthroplasty</keyword>
  <keyword>Patient Expectations</keyword>
  <keyword>Patient Satisfaction</keyword>
  <keyword>Patient Education</keyword>
  <keyword>e-Learning</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>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/NCT01732562
org study id: 103027
nct id: NCT01732562
lead sponsor: 
collaborator: 
has dmc: No
Patients from the Joint Replacement Institute scheduled to undergo primary total knee
      replacement surgery (TKR) will be invited to participate at the Pre Admission Clinic (PAC),
      University Hospital, London Health Sciences Centre. Baseline questionnaires of preoperative
      measures and demographic information and a cost analysis will be explored at the PAC for each
      patient. Patients will be randomized with the treatment group receiving access to a
      web-based, e-learning intervention. Postoperatively all patients will be asked to complete
      questionnaires at 6 weeks, 3 months and 1 year after their TKR surgery.

      Objectives

      The first primary objective is to compare the effect of two methods of providing patient
      education on expectations of surgical outcome in total knee replacement (TKR) patients.

      The second objective is to compare the effect of two methods of providing patient education
      on satisfaction with surgical outcome in TKR patients.

      The intervention of interest is an e-learning education program that spans both the
      preoperative and postoperative time period. The control condition will be the current method
      of patient education provided at the hospital study site.

      Hypothesis: Objective One

      More change in patient expectations will occur between preoperative and one year
      postoperative in the e-learning educational intervention group.

      Hypothesis: Objective Two

      More change in patient satisfaction will occur between preoperative and one year
      postoperative in the e-learning educational intervention group.
This will be a single centre prospective experimental study, involving seven orthopaedic
      surgeons and their patients undergoing total knee replacement (TKR). A consecutive sample of
      elective primary TKR patients will be invited to participate from London Health Sciences
      Centre, University Hospital, London, Ontario, Canada. Additionally, patient hospital charts
      will be accessed to establish the concordance between co-morbidities recorded in patient
      history and self-report measures of co-morbidities.

      Interested patients will be randomized into one of two groups. Group 1 (intervention) will
      receive the e-learning educational intervention in addition to the current method of patient
      education. It will commence at the pre-admission clinic and continue to the study end-point
      of 1-year postoperative. Group 2 (control) will receive the current, existing method utilized
      by each of the seven orthopaedic surgeons for their patient education. At pre-admission,
      patients are provided a 31 page hard copy of My Guide to Total Knee Joint Replacement
      (Revised January, 2008) and they are made aware of an electronic copy of this document
      available at the following website: http://www.jointreplacementinstitute.com/patients.html

      The assumption is that patients can and will read this document to educate themselves about
      their TKR surgery. The interactive e-learning patient education intervention extends beyond
      simple accessibility to information and includes interactive features. The intervention spans
      surgery and rehabilitation aftercare with patients undergoing TKR. Measurements will take
      place at pre-admission before any preoperative education takes place and at 6 weeks, 3 months
      and 1 year after TKR surgery. Patients will have the option of completing questionnaires
      online using Empower or hard copy sent by mail. They will also receive reminders by email or
      phone about completing the questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Patient Expectations
time frame: Change in Patient Expectations from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
description: Patient Expectations will be measured with four distinct domains using single questions related to pain; ability to perform activities of daily living (ADL); ability to participate in sports and global recovery from surgery. Responses are given using a 0 to four scale, with 0 assigned for a not applicable response option: 1= no, I do not expect surgery to help with my pain/ADL/etc., 2= yes, but just a little, 3= yes, somewhat, 4= yes, a lot.
measure: Patient Satisfaction
time frame: Change in Patient Satisfaction from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
description: Patient Satisfaction will be measured using the Patient Acceptable Symptom State Question (PASS). This question will be, "Considering all the activities you do during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" The response options to this question are simply 'yes' or 'no'.
measure: Knee Society Score: Pre-Op
time frame: Change in Knee Society Score: Pre-Op from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Change in KOOS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
measure: Short Form-12 (SF-12) Health Survey
time frame: Change in SF-12 from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Change in HADS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
measure: Pain Catastrophizing Scale (PCS)
time frame: Change in PCS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
measure: Self-Administered Comorbidity Questionnaire (SCQ)
time frame: Baseline measure taken the Pre-Admission Clinic (PAC) visit only.
measure: University of California at Los Angeles (UCLA) Activity Score
time frame: Change in UCLA Activity Score from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
measure: Social Role Participation Questionnaire (SRPQ)
time frame: Change in SRPQ from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
arm group label: Control
arm group type: No Intervention
description: Patient receives the standard of care.
arm group label: Patient e-Learning educational tool
arm group type: Experimental
description: Patient receives the standard of care and access to patient e-Learning educational tool.
intervention type: Other
intervention name: Patient e-Learning educational tool
description: Web based site with videos of TKR surgical animation, demonstrations of exercises and activities following surgery and conversations with surgeons, physiotherapist, occupational therapist and patients.
arm group label: Patient e-Learning educational tool
other name: NewKnees.ca
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Bert M Chesworth, PhD
role: Principal Investigator
affiliation: The University of Western Ontario
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Bert Chesworth
investigator title: Principal Investigator
mesh term: Osteoarthritis
sharing ipd: No