<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/NCT02969512</url>
  </required_header>
  <id_info>
    <org_study_id>H16-02553</org_study_id>
    <nct_id>NCT02969512</nct_id>
  </id_info>
  <brief_title>Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER)</brief_title>
  <acronym>HIPPER</acronym>
  <official_title>Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) Intervention Protocol: An eHealth Approach for Pre-surgical Hip Replacement Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility&#xD;
      impairment. Given the boom in the older demographic it is not surprising that there is an 11%&#xD;
      increased demand for replacement every 5 years in Canada. Health promotion interventions,&#xD;
      such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical&#xD;
      outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient&#xD;
      discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT)&#xD;
      that will assess feasibility indicators and clinical outcomes of online prehab education&#xD;
      modules compared to online educational webinars. The feasibility indicators (process,&#xD;
      resource, management, and treatment issues) and clinical outcomes (physical function,&#xD;
      anxiety, depression, pain, daily activities, self-efficacy, and health related quality of&#xD;
      life) will be assessed among Vancouver-dwelling older adults aged &gt; 50 years, with advanced&#xD;
      hip osteoarthritis. The findings will lead to the refinement of the design protocol in order&#xD;
      to evaluate a contemporary, standardized, and geographically accessible prehab education&#xD;
      program in a large multi-site RCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This feasibility study will use a single-site, parallel group evaluator blind RCT. Subjects&#xD;
      (N=40) will be randomly assigned to the experimental (HIPPER n=20) or control (n=20)&#xD;
      groups.The experimental group will receive the interactive online HIPPER intervention&#xD;
      consisting of 12 modules (~20 mins/module). The control group is usual practice consisting of&#xD;
      a 2 hr online large group educational webinar. Feasibility indicators (i.e. recruitment and&#xD;
      retention; subject burden; safety; intervention administration/adherence; perceived benefit)&#xD;
      will be evaluated as binary outcomes against pre-set parameters reflecting viability for a&#xD;
      multi-site large-scale RCT. The primary clinical outcome of interest when assessing effect&#xD;
      size for the eventual RCT is the Hospital Anxiety and Depression Scale-Anxiety. Secondary&#xD;
      clinical outcomes include measures of pain, function, daily activities, self-efficacy,&#xD;
      equipment checklist, system usability scale, environmental setup, physical activity, and&#xD;
      health related quality of life.&#xD;
&#xD;
      Upon successful screening/enrollment and baseline data collection (T1) the Study Coordinator&#xD;
      will contact the statistician by telephone or email and obtain group assignment within 48&#xD;
      hours. Subjects will be randomized using a 1:1 allocation ratio between groups. A central&#xD;
      computerized randomization process will be designed by the statistician, with an undisclosed&#xD;
      block size. To address bias, subjects will be instructed not to discuss their program and&#xD;
      Testers will reinforce this point at each session. T1 data will be collected at our clinic&#xD;
      while the follow up data collected 7-10 days prior to surgery (T2), and 30 days post-surgery&#xD;
      (T3).&#xD;
&#xD;
      The findings from the study will be summarized and mailed to each participant upon study&#xD;
      completion. HIPPER and control group assessments will be held at GF Strong Rehabilitation&#xD;
      Centre and at subject's homes.&#xD;
&#xD;
      The outcome will lead to the refinement of the design protocol in order to robustly evaluate&#xD;
      a contemporary, standardized, and geographically accessible prehabilitation education&#xD;
      program. Ultimately, HIPPER may be found to have significant individual and social (health&#xD;
      system level) benefits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 10, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Primary Clinical Outcomes Scale</measure>
    <time_frame>Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS-A): The HADS-A is a validated 7-item tool that includes tension, worry and fear and has respondents indicate how they currently feel on each item.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-second Chair-Stand Test</measure>
    <time_frame>Baseline,7-10 days before surgery.</time_frame>
    <description>Functional lower limb strength and dynamic balance will be assessed by having subjects perform repeated sit-to-stands using a standard 43-46 cm straight back chair with no arm rests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity Scale for the Elderly (PASE)</measure>
    <time_frame>Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).</time_frame>
    <description>Patients are less physically active prior to THR and show minimal improvements in activity levels post-operatively. PASE is 12-item tool developed for older adults to assess home, occupational and recreational activities in the previous 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)</measure>
    <time_frame>Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).</time_frame>
    <description>The SER is a 12-item questionnaire that asks patients to rate their confidence on an 11-point Likert scale and generates 2 subscale scores: self-efficacy for rehabilitation therapy exercises and self-efficacy for overcoming barriers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Equipment Checklist</measure>
    <time_frame>Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).</time_frame>
    <description>It is recommended that patients acquire equipment and mobility aids prior to THR to ensure their safety, carry out daily living activities and adhere to surgical precautions post-operatively. A comprehensive checklist of recommended equipment will be created based on current guidelines, clinical recommendations and our Patient Partners' input.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5 Dimension, 5 level</measure>
    <time_frame>Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).</time_frame>
    <description>Health-related quality of life is a core outcome for hip OA and the EQ-5D a suggested measure. The EQ-5D is a brief questionnaire that assesses 5 health status domains, reflected in a single-score, and overall health state using a visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>7-10 days before surgery, Post Intervention (30 days after surgery)</time_frame>
    <description>System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from &quot;Strongly agree&quot; to &quot;Strongly disagree&quot;. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. Some example items are &quot;I think that I would like to use this system frequently.&quot; and &quot;I needed to learn a lot of things before I could get going with this system.&quot; In this study, we replaced &quot;the system&quot; with &quot;Hipper&quot; to capture the opinion of participants regarding the usability of our eHealth program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Hip Score (OHS)</measure>
    <time_frame>Baseline, 7-10 days before surgery, Post Intervention (30 days after surgery)</time_frame>
    <description>The OHS is a 12-item tool that assesses pain and function in patients undergoing hip replacement surgery. It demonstrates good construct validity and test-retest reliability in THR</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hip Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>HIPPER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The HIPPER group will receive 12 interactive online modules (~20 minutes each). HIPPER participants will receive email or phone contact (participant preference) to provide them with website portal access consisting of the web address, and simple instructions to access the website using personalized encrypted login information to the site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OASIS Online Educational Webinars</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To provide a comparable level of education, participants in the Online Education group will receive 2 hours of OASIS online educational webinars as per current practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIPPER</intervention_name>
    <description>Participants can complete the online educational modules at home or another location with internet access. The total time to complete all of the modules is about 2 hours and 30 minutes.</description>
    <arm_group_label>HIPPER</arm_group_label>
    <other_name>Behavioral: Online prehab education</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OASIS Online Educational Webinars</intervention_name>
    <description>2-hour online educational large group sessions</description>
    <arm_group_label>OASIS Online Educational Webinars</arm_group_label>
    <other_name>Behavioral: large group education sessions</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Community-dwelling participants with advanced hip OA will be included if they:&#xD;
&#xD;
          -  are living in the greater Vancouver region;&#xD;
&#xD;
          -  are aged 50 years or older;&#xD;
&#xD;
          -  are scheduled to have a single THR in 12 weeks or later;&#xD;
&#xD;
          -  have access to the internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cannot communicate and complete questionnaires in English;&#xD;
&#xD;
          -  anticipate a health condition or procedure that contraindicates their THR surgery;&#xD;
&#xD;
          -  are actively receiving physical therapy for their hip symptoms;&#xD;
&#xD;
          -  have had a previous THR.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William C Miller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Somayyeh Mohammadi, PhD</last_name>
    <phone>604-714-4108</phone>
    <email>somayyeh.mohammadi@ubc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>GF Strong Rehabilitation Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 2G9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>William C Miller, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>William C. Miller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Patient education</keyword>
  <keyword>Advanced hip osteoarthritis</keyword>
  <keyword>Online education</keyword>
  <keyword>Computer-assisted instruction</keyword>
  <keyword>e-learning</keyword>
  <keyword>Older adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</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/NCT02969512
org study id: H16-02553
nct id: NCT02969512
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility
      impairment. Given the boom in the older demographic it is not surprising that there is an 11%
      increased demand for replacement every 5 years in Canada. Health promotion interventions,
      such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical
      outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient
      discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT)
      that will assess feasibility indicators and clinical outcomes of online prehab education
      modules compared to online educational webinars. The feasibility indicators (process,
      resource, management, and treatment issues) and clinical outcomes (physical function,
      anxiety, depression, pain, daily activities, self-efficacy, and health related quality of
      life) will be assessed among Vancouver-dwelling older adults aged > 50 years, with advanced
      hip osteoarthritis. The findings will lead to the refinement of the design protocol in order
      to evaluate a contemporary, standardized, and geographically accessible prehab education
      program in a large multi-site RCT.
This feasibility study will use a single-site, parallel group evaluator blind RCT. Subjects
      (N=40) will be randomly assigned to the experimental (HIPPER n=20) or control (n=20)
      groups.The experimental group will receive the interactive online HIPPER intervention
      consisting of 12 modules (~20 mins/module). The control group is usual practice consisting of
      a 2 hr online large group educational webinar. Feasibility indicators (i.e. recruitment and
      retention; subject burden; safety; intervention administration/adherence; perceived benefit)
      will be evaluated as binary outcomes against pre-set parameters reflecting viability for a
      multi-site large-scale RCT. The primary clinical outcome of interest when assessing effect
      size for the eventual RCT is the Hospital Anxiety and Depression Scale-Anxiety. Secondary
      clinical outcomes include measures of pain, function, daily activities, self-efficacy,
      equipment checklist, system usability scale, environmental setup, physical activity, and
      health related quality of life.

      Upon successful screening/enrollment and baseline data collection (T1) the Study Coordinator
      will contact the statistician by telephone or email and obtain group assignment within 48
      hours. Subjects will be randomized using a 1:1 allocation ratio between groups. A central
      computerized randomization process will be designed by the statistician, with an undisclosed
      block size. To address bias, subjects will be instructed not to discuss their program and
      Testers will reinforce this point at each session. T1 data will be collected at our clinic
      while the follow up data collected 7-10 days prior to surgery (T2), and 30 days post-surgery
      (T3).

      The findings from the study will be summarized and mailed to each participant upon study
      completion. HIPPER and control group assessments will be held at GF Strong Rehabilitation
      Centre and at subject's homes.

      The outcome will lead to the refinement of the design protocol in order to robustly evaluate
      a contemporary, standardized, and geographically accessible prehabilitation education
      program. Ultimately, HIPPER may be found to have significant individual and social (health
      system level) benefits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change in Primary Clinical Outcomes Scale
time frame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
description: Hospital Anxiety and Depression Scale (HADS-A): The HADS-A is a validated 7-item tool that includes tension, worry and fear and has respondents indicate how they currently feel on each item.
measure: 30-second Chair-Stand Test
time frame: Baseline,7-10 days before surgery.
description: Functional lower limb strength and dynamic balance will be assessed by having subjects perform repeated sit-to-stands using a standard 43-46 cm straight back chair with no arm rests.
measure: Change in Physical Activity Scale for the Elderly (PASE)
time frame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
description: Patients are less physically active prior to THR and show minimal improvements in activity levels post-operatively. PASE is 12-item tool developed for older adults to assess home, occupational and recreational activities in the previous 7 days.
measure: Change in Self-Efficacy for Rehabilitation Outcome Scale (SER)
time frame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
description: The SER is a 12-item questionnaire that asks patients to rate their confidence on an 11-point Likert scale and generates 2 subscale scores: self-efficacy for rehabilitation therapy exercises and self-efficacy for overcoming barriers.
measure: Equipment Checklist
time frame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
description: It is recommended that patients acquire equipment and mobility aids prior to THR to ensure their safety, carry out daily living activities and adhere to surgical precautions post-operatively. A comprehensive checklist of recommended equipment will be created based on current guidelines, clinical recommendations and our Patient Partners' input.
measure: EuroQol-5 Dimension, 5 level
time frame: Baseline,7-10 days before surgery, Post Intervention (30 days after surgery).
description: Health-related quality of life is a core outcome for hip OA and the EQ-5D a suggested measure. The EQ-5D is a brief questionnaire that assesses 5 health status domains, reflected in a single-score, and overall health state using a visual analogue scale.
measure: System Usability Scale
time frame: 7-10 days before surgery, Post Intervention (30 days after surgery)
description: System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from "Strongly agree" to "Strongly disagree". Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. Some example items are "I think that I would like to use this system frequently." and "I needed to learn a lot of things before I could get going with this system." In this study, we replaced "the system" with "Hipper" to capture the opinion of participants regarding the usability of our eHealth program
measure: Oxford Hip Score (OHS)
time frame: Baseline, 7-10 days before surgery, Post Intervention (30 days after surgery)
description: The OHS is a 12-item tool that assesses pain and function in patients undergoing hip replacement surgery. It demonstrates good construct validity and test-retest reliability in THR
arm group label: HIPPER
arm group type: Experimental
description: The HIPPER group will receive 12 interactive online modules (~20 minutes each). HIPPER participants will receive email or phone contact (participant preference) to provide them with website portal access consisting of the web address, and simple instructions to access the website using personalized encrypted login information to the site.
arm group label: OASIS Online Educational Webinars
arm group type: Active Comparator
description: To provide a comparable level of education, participants in the Online Education group will receive 2 hours of OASIS online educational webinars as per current practice.
intervention type: Other
intervention name: HIPPER
description: Participants can complete the online educational modules at home or another location with internet access. The total time to complete all of the modules is about 2 hours and 30 minutes.
arm group label: HIPPER
other name: Behavioral: Online prehab education
intervention type: Other
intervention name: OASIS Online Educational Webinars
description: 2-hour online educational large group sessions
arm group label: OASIS Online Educational Webinars
other name: Behavioral: large group education sessions
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: William C Miller, PhD
role: Principal Investigator
affiliation: University of British Columbia
last name: Somayyeh Mohammadi, PhD
phone: 604-714-4108
email: somayyeh.mohammadi@ubc.ca
facility: 
status: Recruiting
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: William C. Miller
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
sharing ipd: No