xml: <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/NCT05965986</url>
    </required_header>
    <id_info>
      <org_study_id>120163</org_study_id>
      <nct_id>NCT05965986</nct_id>
    </id_info>
    <brief_title>Preoperative Rehabilitation and Education Program</brief_title>
    <acronym>PREPS</acronym>
    <official_title>Preoperative Patient Education and Rehabilitation Program for a Total Shoulder Arthroplasty Surgery: a Pilot Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lawson Health Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Western University, Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Lawson Health Research Institute</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>
        Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments&#xD;
        for shoulder problems, patients are unaware about shoulder replacement surgeries, the&#xD;
        exercises needed after surgery and how to safely recover from the surgery without having&#xD;
        another injury. Uncertainties about the surgery and recovery process can further cause&#xD;
        post-surgery problems such as: pain, anxiety and re-injury. While some healthcare centers&#xD;
        offer an in- class program to educate patients before surgery, some patients face issues with&#xD;
        distance or transportation, and cannot regularly meet their doctor to address all their&#xD;
        concerns. This project aims to create an online educational program that will teach patients&#xD;
        through online videos and educational materials before they go into shoulder replacement&#xD;
        surgery. By creating online modules, it can increase the accessibility for home use, and&#xD;
        prepare patients on topics such as: their concerns about the surgery and proper exercises&#xD;
        they can expect after surgery for a safe recovery. The aim is to study three groups of&#xD;
        patients before surgery; 1. a group consisting of an online pre-rehabilitation program 6&#xD;
        weeks before surgery, 2. a group consisting of an online pre-rehabilitation program 6 weeks&#xD;
        before surgery + therapist or 3. A group consisting of the current standard of care, which is&#xD;
        a WebEx pre-operative education class lead by a physiotherapist and occupational therapist.&#xD;
        Researchers will monitor all groups on their recovery before and after surgery. This will&#xD;
        provide another alternative to informing patients before surgery and help them to prepare&#xD;
        better for surgery. The online modules will contribute to improving the care in Southern&#xD;
        Ontario and eventually be used for future care across Canada.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total shoulder replacement is a common procedure to help those with shoulder osteoarthritis&#xD;
        improve their quality of life. There is a lack of quality research on the effectiveness of&#xD;
        prehabilitation and education on pain, function, and quality of life in patients undergoing&#xD;
        this procedure. Researchers have developed a comprehensive, patient-centered program that&#xD;
        combines exercise, preparedness for surgery, motivational interviewing, and pain management&#xD;
        principles, in collaboration with patient partners on the wait list for a shoulder&#xD;
        replacement, transdisciplinary healthcare team (i.e., surgeons, physiotherapists,&#xD;
        occupational therapists, and rehabilitation researchers), and current scientific literature.&#xD;
        This patient-centered program has the potential to improve postoperative pain, function, and&#xD;
        patient-oriented outcomes, decrease postoperative opioid use and short and long-term&#xD;
        healthcare costs. This pilot randomized controlled trial will evaluate feasibility and&#xD;
        satisfaction of the program for individuals undergoing a shoulder replacement. Participants&#xD;
        (n=90) undergoing a shoulder replacement will be randomized into 1) 6-week online pre-rehab&#xD;
        and education program, 2) 6-week online pre-rehab and education program with a therapist or&#xD;
        3) standard of care group. The intervention groups will be delivered virtually with an online&#xD;
        program of modules and a written handbook for participants. Participants in the standard of&#xD;
        care group will receive usual care. Outcomes will be assessed at baseline and 1 day before&#xD;
        surgery, then post-operatively at 6 weeks, 3 months, 6 months and 12 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment Rate log</measure>
      <time_frame>6 months</time_frame>
      <description>We will proceed with the larger trial if we are able to recruit 90 participants within 6 months, and if 50% of eligible participants consent to participate.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence Rate log</measure>
      <time_frame>6 months</time_frame>
      <description>Adherence to the education program will be considered adequate if 80% of all participants in the intervention groups complete the full online program and report it on the log. Exercise programs will be considered adequate if 60% of participants in the intervention groups report exercise at least 3 times per week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Content Acceptability - visual analog scale</measure>
      <time_frame>12 months</time_frame>
      <description>Content acceptability will be assessed using a visual analog scale (VAS), where acceptability will be considered adequate if 60% of participants found the treatment useful and helpful with a score of 7/10.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Study Acceptability - visual analog scale</measure>
      <time_frame>12 months</time_frame>
      <description>Similarly, if 60% of participants found the treatment delivery acceptable, and reported being likely to use this treatment again and recommend it to others with a VAS score of 7/10, the format will be considered acceptable.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Fidelity checklist</measure>
      <time_frame>12 months</time_frame>
      <description>if 80% of phone calls were documented accurately and able to meet the criteria of the checklist by the therapist, fidelity will be considered acceptable.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>5-level EQ-5D version</measure>
      <time_frame>12 months</time_frame>
      <description>General Health Status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Simple Shoulder Test</measure>
      <time_frame>12 months</time_frame>
      <description>functional outcome measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Single Assessment Numeric Evaluation</measure>
      <time_frame>12 months</time_frame>
      <description>functional outcome measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>12 months</time_frame>
      <description>shoulder movement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical Satisfaction Questionnaire</measure>
      <time_frame>3 months</time_frame>
      <description>satisfaction with surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decisional Regret</measure>
      <time_frame>3 months</time_frame>
      <description>decisional conflict with surgery or the preparation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to rehabilitation</measure>
      <time_frame>12 months</time_frame>
      <description>adherence to a post-surgery rehabilitation program</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PASS</measure>
      <time_frame>12 months</time_frame>
      <description>Single item to understand people's satisfaction with their current health condition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shoulder Pain and Disability Index</measure>
      <time_frame>12 months</time_frame>
      <description>shoulder pain and function for shoulder conditions</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Shoulder Arthritis</condition>
    <condition>Patient Education</condition>
    <condition>Prehabilitation</condition>
    <condition>Shoulder Arthroplasty</condition>
    <arm_group>
      <arm_group_label>Standard of Care Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A group consisting of the current standard of care at HULC, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a group consisting of an online pre-rehabilitation program 6 weeks before surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online and PT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Experimental: PREPS only</intervention_name>
      <description>Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification.&#xD;
  The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative.</description>
      <arm_group_label>Online only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Experimental: PREPS and therapy</intervention_name>
      <description>Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification.&#xD;
  The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative. In addition, participants will have a therapist call on week 2 and 4 of the program and then one week after surgery to check in and ensure the patient is meeting all milestones and answer any questions.</description>
      <arm_group_label>Online and PT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over the age of 18 years old&#xD;
  &#xD;
            -  Patients who have consented for a total shoulder arthroplasty or reverse shoulder&#xD;
               arthroplasty surgery at HULC.&#xD;
  &#xD;
            -  Date of surgery must be no shorter than 9 weeks, to ensure time for baseline measures&#xD;
  &#xD;
            -  Speaks and reads in English unless can provide a translator&#xD;
  &#xD;
            -  Able to provide informed consent.&#xD;
  &#xD;
            -  Willing to participate in study procedures for at least 1 year post-surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have consented for a hemi-arthroplasty surgery&#xD;
  &#xD;
            -  Patients who have been consented less than 8 weeks before surgery&#xD;
  &#xD;
            -  Any contraindications to exercise&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joy MacDermid, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Western University, Canada</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joy MacDermid, PhD</last_name>
      <phone>5196466100</phone>
      <phone_ext>64636</phone_ext>
      <email>jmacderm@uwo.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katrina Munro</last_name>
      <phone>5196466100</phone>
      <phone_ext>64640</phone_ext>
      <email>katrina.munro@sjhc.london.on.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Roth | McFarlane Hand and Upper Limb Center</name>
        <address>
          <city>London</city>
          <state>Ontario</state>
          <zip>N6A4L6</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Joy MacDermid, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
      <investigator_full_name>Joy MacDermid</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965986
  org study id: 120163
  nct id: NCT05965986
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments
        for shoulder problems, patients are unaware about shoulder replacement surgeries, the
        exercises needed after surgery and how to safely recover from the surgery without having
        another injury. Uncertainties about the surgery and recovery process can further cause
        post-surgery problems such as: pain, anxiety and re-injury. While some healthcare centers
        offer an in- class program to educate patients before surgery, some patients face issues with
        distance or transportation, and cannot regularly meet their doctor to address all their
        concerns. This project aims to create an online educational program that will teach patients
        through online videos and educational materials before they go into shoulder replacement
        surgery. By creating online modules, it can increase the accessibility for home use, and
        prepare patients on topics such as: their concerns about the surgery and proper exercises
        they can expect after surgery for a safe recovery. The aim is to study three groups of
        patients before surgery; 1. a group consisting of an online pre-rehabilitation program 6
        weeks before surgery, 2. a group consisting of an online pre-rehabilitation program 6 weeks
        before surgery + therapist or 3. A group consisting of the current standard of care, which is
        a WebEx pre-operative education class lead by a physiotherapist and occupational therapist.
        Researchers will monitor all groups on their recovery before and after surgery. This will
        provide another alternative to informing patients before surgery and help them to prepare
        better for surgery. The online modules will contribute to improving the care in Southern
        Ontario and eventually be used for future care across Canada.
  A total shoulder replacement is a common procedure to help those with shoulder osteoarthritis
        improve their quality of life. There is a lack of quality research on the effectiveness of
        prehabilitation and education on pain, function, and quality of life in patients undergoing
        this procedure. Researchers have developed a comprehensive, patient-centered program that
        combines exercise, preparedness for surgery, motivational interviewing, and pain management
        principles, in collaboration with patient partners on the wait list for a shoulder
        replacement, transdisciplinary healthcare team (i.e., surgeons, physiotherapists,
        occupational therapists, and rehabilitation researchers), and current scientific literature.
        This patient-centered program has the potential to improve postoperative pain, function, and
        patient-oriented outcomes, decrease postoperative opioid use and short and long-term
        healthcare costs. This pilot randomized controlled trial will evaluate feasibility and
        satisfaction of the program for individuals undergoing a shoulder replacement. Participants
        (n=90) undergoing a shoulder replacement will be randomized into 1) 6-week online pre-rehab
        and education program, 2) 6-week online pre-rehab and education program with a therapist or
        3) standard of care group. The intervention groups will be delivered virtually with an online
        program of modules and a written handbook for participants. Participants in the standard of
        care group will receive usual care. Outcomes will be assessed at baseline and 1 day before
        surgery, then post-operatively at 6 weeks, 3 months, 6 months and 12 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  measure: Recruitment Rate log
  time frame: 6 months
  description: We will proceed with the larger trial if we are able to recruit 90 participants within 6 months, and if 50% of eligible participants consent to participate.
  measure: Adherence Rate log
  time frame: 6 months
  description: Adherence to the education program will be considered adequate if 80% of all participants in the intervention groups complete the full online program and report it on the log. Exercise programs will be considered adequate if 60% of participants in the intervention groups report exercise at least 3 times per week.
  measure: Content Acceptability - visual analog scale
  time frame: 12 months
  description: Content acceptability will be assessed using a visual analog scale (VAS), where acceptability will be considered adequate if 60% of participants found the treatment useful and helpful with a score of 7/10.
  measure: Study Acceptability - visual analog scale
  time frame: 12 months
  description: Similarly, if 60% of participants found the treatment delivery acceptable, and reported being likely to use this treatment again and recommend it to others with a VAS score of 7/10, the format will be considered acceptable.
  measure: Treatment Fidelity checklist
  time frame: 12 months
  description: if 80% of phone calls were documented accurately and able to meet the criteria of the checklist by the therapist, fidelity will be considered acceptable.
  measure: 5-level EQ-5D version
  time frame: 12 months
  description: General Health Status
  measure: Simple Shoulder Test
  time frame: 12 months
  description: functional outcome measure
  measure: Single Assessment Numeric Evaluation
  time frame: 12 months
  description: functional outcome measure
  measure: Range of motion
  time frame: 12 months
  description: shoulder movement
  measure: Surgical Satisfaction Questionnaire
  time frame: 3 months
  description: satisfaction with surgery
  measure: Decisional Regret
  time frame: 3 months
  description: decisional conflict with surgery or the preparation
  measure: Adherence to rehabilitation
  time frame: 12 months
  description: adherence to a post-surgery rehabilitation program
  measure: PASS
  time frame: 12 months
  description: Single item to understand people's satisfaction with their current health condition
  measure: Shoulder Pain and Disability Index
  time frame: 12 months
  description: shoulder pain and function for shoulder conditions
  arm group label: Standard of Care Group
  arm group type: No Intervention
  description: A group consisting of the current standard of care at HULC, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist.
  arm group label: Online only
  arm group type: Experimental
  description: a group consisting of an online pre-rehabilitation program 6 weeks before surgery
  arm group label: Online and PT
  arm group type: Experimental
  description: a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist
  intervention type: Other
  intervention name: Experimental: PREPS only
  description: Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification.
  The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative.
  arm group label: Online only
  intervention type: Other
  intervention name: Experimental: PREPS and therapy
  description: Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification.
  The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative. In addition, participants will have a therapist call on week 2 and 4 of the program and then one week after surgery to check in and ensure the patient is meeting all milestones and answer any questions.
  arm group label: Online and PT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Joy MacDermid, PhD
  role: Principal Investigator
  affiliation: Western University, Canada
  last name: Joy MacDermid, PhD
  phone: 5196466100
  phone ext: 64636
  email: jmacderm@uwo.ca
  last name: Katrina Munro
  phone: 5196466100
  phone ext: 64640
  email: katrina.munro@sjhc.london.on.ca
  facility: 
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Lawson Health Research Institute
  investigator full name: Joy MacDermid
  investigator title: Professor
  mesh term: Arthritis
  sharing ipd: No