<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/NCT02221115</url>
  </required_header>
  <id_info>
    <org_study_id>SDR 14.135</org_study_id>
    <secondary_id>RI-MUHC - MGH</secondary_id>
    <nct_id>NCT02221115</nct_id>
  </id_info>
  <brief_title>A Survey of Google Glass by Orthopaedic Trauma Patients and Surgeons</brief_title>
  <acronym>GoogleGlass</acronym>
  <official_title>A Survey-driven Evaluation of Patients Response to the Introduction of Google Glass in the Orthopaedic Trauma Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential&#xD;
      video/picture recording using the Google Glass device during their visit with the orthopaedic&#xD;
      surgeon or resident.&#xD;
&#xD;
      The investigators want to record the patient's level of acceptance and response to this new&#xD;
      technology. There are two arms: Patients seen by a doctor wearing the Google Glass device and&#xD;
      those that will not be exposed. Both groups will be asked to complete a survey after their&#xD;
      clinic visit.&#xD;
&#xD;
      The device users (doctor) will complete a survey which will evaluate how effective this new&#xD;
      tool is in the Orthopaedic clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Google Glass is a new low-profile wearable technology that allows physicians to record&#xD;
      hands-free video and pictures and to directly video link and communicate with other wearers&#xD;
      of this device. In addition to this, the device has a heads up display that is capable of&#xD;
      searching the internet on voice command. The device has the same functionality as a smart&#xD;
      phone with the benefit of being hands-free and wearable. The device is currently in a beta&#xD;
      testing period where &quot;Explorers&quot; are accepted by application to a program to use and assess&#xD;
      the device. The investigators have been able to obtain three of these devices.&#xD;
&#xD;
      The Google Glass device has the ability to help improve connectivity between physicians not&#xD;
      in the same locale, increase efficiency and provide better access to vital information used&#xD;
      in a medical and surgical setting. The device has clear teaching implications and will enable&#xD;
      academic physicians to disseminate information to more students and in situations not&#xD;
      previously possible. As the device evolves its potential to do more will likely develop&#xD;
      further. It is important to assess the impact of this rapidly growing field on patient&#xD;
      sentiment and wellbeing. As this is a very new device, very few studies have been done to&#xD;
      assess its application in Medicine and specifically orthopaedic surgery. So far only very&#xD;
      specific and small studies have been done with regard to immunochromatographic analysis,&#xD;
      pharmacology, forensic medicine and Parkinson's disease. The investigators are aiming to&#xD;
      assess the applications and patient perspective of this device on a much larger scale. The&#xD;
      investigators feel this technology and its future offspring could be polarizing with regard&#xD;
      to patient response. This could be an important element to consider in the future development&#xD;
      of its clinical applications.&#xD;
&#xD;
      There are no direct medical risks to the patient. No decisions regarding patient care will be&#xD;
      dependent on the device.&#xD;
&#xD;
      Study Objective Primary question: What is the patient's level of acceptance and response to&#xD;
      this new technology? Secondary question: From a doctor's perspective, how effective is this&#xD;
      new tool in the Orthopaedic clinical setting?&#xD;
&#xD;
      Design Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential&#xD;
      video/picture recording using the Google Glass device during their visit with the orthopaedic&#xD;
      surgeon or resident. Eligible patients will be assigned to one of two consulting rooms: one&#xD;
      with the Google Glass device, one without.&#xD;
&#xD;
      Patients will therefore have a 50.50 chance of encountering the Google Glass.&#xD;
&#xD;
      Any images or videos taken will not show the patients face, all measures will be taken to&#xD;
      ensure confidentiality. Both groups will be asked to complete a small survey on a locked&#xD;
      password protected iPad after their visit so as to record their acceptability of this new&#xD;
      technology in a clinical setting. Participants that experienced the device will also be&#xD;
      required to comment on their experience. The device user (surgeon/resident) will also&#xD;
      complete a survey so as to record their experience using the hands free camera and recording&#xD;
      device.&#xD;
&#xD;
      The information gathered will be saved on a password protected drive and will be used for&#xD;
      discussion and analysis between the investigators to help develop the potential future&#xD;
      teaching and clinical applications of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Evaluation Survey</measure>
    <time_frame>Day one</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgeon Evaluation Survey</measure>
    <time_frame>Day one</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Orthopedic Disorders</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Google Glass</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Investigators using Google Glass during clinic visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Google Glass</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Investigator will not be using Google Glass during clinic visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Google Glass</intervention_name>
    <description>The device is a wearable, voice-controlled Android device that resembles a pair of eyeglasses and displays information directly in the user's field of vision</description>
    <arm_group_label>Google Glass</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients seen in the Montreal general Hospital (MGH) - Orthopaedic Trauma Clinic&#xD;
             and capable of reading French or English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients that have cognitive impairment or language difficulties that would impede&#xD;
             completion of the survey will be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward J Harvey, MDCM FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>RI-MUHC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>May 13, 2020</last_update_submitted>
  <last_update_submitted_qc>May 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Edward Harvey</investigator_full_name>
    <investigator_title>MDCM FRCSC</investigator_title>
  </responsible_party>
  <keyword>Google Glass device</keyword>
  <keyword>Evaluation</keyword>
  <keyword>patient's</keyword>
  <keyword>response</keyword>
  <keyword>to new technology</keyword>
  <keyword>clinical setting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02221115
org study id: SDR 14.135
secondary id: RI-MUHC - MGH
nct id: NCT02221115
lead sponsor: 
has dmc: No
Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential
      video/picture recording using the Google Glass device during their visit with the orthopaedic
      surgeon or resident.

      The investigators want to record the patient's level of acceptance and response to this new
      technology. There are two arms: Patients seen by a doctor wearing the Google Glass device and
      those that will not be exposed. Both groups will be asked to complete a survey after their
      clinic visit.

      The device users (doctor) will complete a survey which will evaluate how effective this new
      tool is in the Orthopaedic clinical setting.
Google Glass is a new low-profile wearable technology that allows physicians to record
      hands-free video and pictures and to directly video link and communicate with other wearers
      of this device. In addition to this, the device has a heads up display that is capable of
      searching the internet on voice command. The device has the same functionality as a smart
      phone with the benefit of being hands-free and wearable. The device is currently in a beta
      testing period where "Explorers" are accepted by application to a program to use and assess
      the device. The investigators have been able to obtain three of these devices.

      The Google Glass device has the ability to help improve connectivity between physicians not
      in the same locale, increase efficiency and provide better access to vital information used
      in a medical and surgical setting. The device has clear teaching implications and will enable
      academic physicians to disseminate information to more students and in situations not
      previously possible. As the device evolves its potential to do more will likely develop
      further. It is important to assess the impact of this rapidly growing field on patient
      sentiment and wellbeing. As this is a very new device, very few studies have been done to
      assess its application in Medicine and specifically orthopaedic surgery. So far only very
      specific and small studies have been done with regard to immunochromatographic analysis,
      pharmacology, forensic medicine and Parkinson's disease. The investigators are aiming to
      assess the applications and patient perspective of this device on a much larger scale. The
      investigators feel this technology and its future offspring could be polarizing with regard
      to patient response. This could be an important element to consider in the future development
      of its clinical applications.

      There are no direct medical risks to the patient. No decisions regarding patient care will be
      dependent on the device.

      Study Objective Primary question: What is the patient's level of acceptance and response to
      this new technology? Secondary question: From a doctor's perspective, how effective is this
      new tool in the Orthopaedic clinical setting?

      Design Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential
      video/picture recording using the Google Glass device during their visit with the orthopaedic
      surgeon or resident. Eligible patients will be assigned to one of two consulting rooms: one
      with the Google Glass device, one without.

      Patients will therefore have a 50.50 chance of encountering the Google Glass.

      Any images or videos taken will not show the patients face, all measures will be taken to
      ensure confidentiality. Both groups will be asked to complete a small survey on a locked
      password protected iPad after their visit so as to record their acceptability of this new
      technology in a clinical setting. Participants that experienced the device will also be
      required to comment on their experience. The device user (surgeon/resident) will also
      complete a survey so as to record their experience using the hands free camera and recording
      device.

      The information gathered will be saved on a password protected drive and will be used for
      discussion and analysis between the investigators to help develop the potential future
      teaching and clinical applications of the device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient Evaluation Survey
time frame: Day one
measure: Surgeon Evaluation Survey
time frame: Day one
arm group label: Google Glass
arm group type: Other
description: Investigators using Google Glass during clinic visit
arm group label: No Google Glass
arm group type: No Intervention
description: Investigator will not be using Google Glass during clinic visit
intervention type: Device
intervention name: Google Glass
description: The device is a wearable, voice-controlled Android device that resembles a pair of eyeglasses and displays information directly in the user's field of vision
arm group label: Google Glass
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edward J Harvey, MDCM FRCSC
role: Principal Investigator
affiliation: RI-MUHC
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Edward Harvey
investigator title: MDCM FRCSC
mesh term: Musculoskeletal Diseases
mesh term: Wounds and Injuries
sharing ipd: No