<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/NCT04444297</url>
  </required_header>
  <id_info>
    <org_study_id>GN20HS287</org_study_id>
    <nct_id>NCT04444297</nct_id>
  </id_info>
  <brief_title>3D Telemedicine During COVID-19: Non-clinical Validation</brief_title>
  <official_title>3D Telemedicine During COVID-19: Non-clinical Validation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jean Brown Bequest Fund, Glasgow, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</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>
      Telemedicine will be used as standard practice during the Covid Pandemic, in order to reduce&#xD;
      clinician exposure to patients and potential high viral load, and reduce patient footfall in&#xD;
      a hospital caring for Covid patients. The 3D telemedicine uses multiple cameras in the clinic&#xD;
      room which can reconstruct an image in 3 dimensions. This may give more information about a&#xD;
      patient's condition, particularly in more visual specialties such as Plastic Surgery. The&#xD;
      systems have hospital approval to be used for telemedicine, all equipment is CE marked. There&#xD;
      are no data regarding the use of 3D telemedicine, but similar studies have been performed in&#xD;
      many fields including orthopaedic surgery using 2D telemedicine (Buvik 2016). This study aims&#xD;
      to provide non-clinical validations of the 3D telemedicine for usability, presence,&#xD;
      satisfaction and reliability, using healthy volunteers only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Methods The study will involve non-clinical validation with no patients and no&#xD;
      interventions. The study will investigate usability, presence, satisfaction and reliability&#xD;
      data for 3D telemedicine, and provide subjective feedback in the form of a semi-structured&#xD;
      interview.&#xD;
&#xD;
      Participants Healthy volunteers from the staff at Canniesburn Regional Plastic Surgery and&#xD;
      Burns Unit, Glasgow Royal Infirmary and West Glasgow ACH, Greater Glasgow and Clyde.&#xD;
&#xD;
      Inclusions and exclusion Healthy staff/students. Recruitment from all contacted, eligible&#xD;
      participants will be recorded. Exclusion criteria include visual problems not correctable&#xD;
      with glasses/dyslexia.&#xD;
&#xD;
      Consent Participants will be consented in writing for inclusion in the study. The consent&#xD;
      will specify that data may be recorded for research and further analysis by the research&#xD;
      team, and be available for technical purposes by the research team's industrial partner&#xD;
&#xD;
      Sample Size&#xD;
&#xD;
      30-40 participants for Presence and Usability Questionnaires.&#xD;
&#xD;
      Participants will examine other participants (where one acts as a &quot;doctor&quot; and one acts as a&#xD;
      &quot;patient&quot;) to provide indicators of usability, presence and task load index. All participants&#xD;
      will assess other participants using the screening tasks below (estimated 10 mins maximum):&#xD;
&#xD;
      Screening Tasks: asking &quot;patient&quot; to follow instructions Upper Limb: Functional screening&#xD;
      upper limb - hands above head, brush teeth, hands behind back, pro-supination, wrist,&#xD;
      prehension grips (power, span, pinch, key, tripod) Lower limb: Functional assessment of lower&#xD;
      limb - walk, straight leg raise, take shoes off and examine sole of feet Head: examine worm's&#xD;
      eye view of nose, side of nose and top of scalp.&#xD;
&#xD;
      Performing a &quot;task&quot; Perform a form of physiotherapy or equivalent task (chosen at random)&#xD;
      such as describing to patient the use of an anterolateral thigh flap for tumour&#xD;
      reconstruction.&#xD;
&#xD;
      Outcomes assessed: validated questionnaires, time taken to complete screening tasks, NASA&#xD;
      task load index&#xD;
&#xD;
      Randomisation Participants will be randomized to see &quot;patients&quot; in 3D or 2D first. This will&#xD;
      be by blocked randomisation using a list and sealed envelopes.&#xD;
&#xD;
      Outcome Measures&#xD;
&#xD;
      Multiple measures of usability and presence will be used. This will be to form baseline data&#xD;
      on the 3D telemedicine system (e.g. System usability score &gt;68 is &quot;good&quot;), but also to&#xD;
      determine the sensitivity of the various instruments to record overall satisfaction with the&#xD;
      systems. This will help to determine the most appropriate instruments for the clinical&#xD;
      validation.&#xD;
&#xD;
      Mental Effort Rating Scale - single instrument Likert scale (Paas 1996) University of North&#xD;
      Northway - 5 item - telemedicine questionnaire (Buvik 2016) System Usability Scale - 10 item&#xD;
      scale - industry standard for usability of technology (Brooke 1986) Presence Questionnaire -&#xD;
      29 item scale - assessment of presence in the system/virtual environment (PQ, Witmer 2005).&#xD;
&#xD;
      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine NASA TLX -&#xD;
      task load index - 5 item modified scale - an indication of the ease of performing a task and&#xD;
      frustration levels.&#xD;
&#xD;
      Overall Telemedicine Satisfaction - VAS Semi Structured exit interview - will discuss with&#xD;
      participant their views on the telemedicine system and how we can improve.&#xD;
&#xD;
      Statistics and Analysis&#xD;
&#xD;
      The values obtained for the different rating scales will be summarised, in order to provide a&#xD;
      basis for future sample size calculations. With a sample size of 40, the confidence interval&#xD;
      around an estimated standard deviation s would be 0.819 s to 1.284 s. With a sample size of&#xD;
      50 it would be 0.835 s to 1.246 (Sim 2012).&#xD;
&#xD;
      The relation between the various rating scales and overall telemedicine satisfaction will be&#xD;
      assessed using linear mixed effects regression analysis predicting overall telemedicine&#xD;
      satisfaction from the rating scale and type of telemedicine, including a random effect for&#xD;
      participant.&#xD;
&#xD;
      The research team will examine whether higher &quot;presence&quot; scores (on Presence Questionnaire)&#xD;
      translate to less &quot;frustration&quot; (on NASA TLX), and whether this results in less error/time&#xD;
      taken to complete tasks. This will be done using linear mixed effects regression analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomised to 2D then 3D, or 3D then 3D telemedicine consultations</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator and outcomes assessor will be blinded to method of telemedicine. It is not possible to blind participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Presence Questionnaire</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Version 3 of PQ, 29 item rating scale of &quot;presence&quot;. Witmer 2005</description>
  </primary_outcome>
  <primary_outcome>
    <measure>University Hospital of North Northway Questionnaire</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient)</time_frame>
    <description>5 item questionnaire on telemedicine quality. UNN Buvik 2016.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Telehealth Usability Questionnaire</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>21 item scale - assessment of telemedicine (TUQ, Parmanto 2016)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>10 item industry standard technology scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Effort Rating Scale</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Single instrument Likert scale (Paas 1996)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NASA TLX</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Measure of task load index - 5 item modified scale - an indication of the ease of performing a task and frustration levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion measurements for elbow joint</measure>
    <time_frame>Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]</time_frame>
    <description>Range of Motion measurements for elbow joint measured with face-to-face goniometer or on computer (telemedicine)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Telemedicine</condition>
  <condition>Surgery, Plastic</condition>
  <arm_group>
    <arm_group_label>2D telemedicine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2D telemedicine first, followed by crossover to 3D telemedicine with no washout period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3D Telemedicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3D telemedicine first, followed by crossover to 2D telemedicine with no washout period</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3D Telemedicine</intervention_name>
    <description>A consultation performed with a 3D form of telemedicine</description>
    <arm_group_label>3D Telemedicine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2D Telemedicine</intervention_name>
    <description>A consultation performed with 2D (standard) telemedicine</description>
    <arm_group_label>2D telemedicine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers from staff at NHS GGC.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  visual problems not correctable with glasses&#xD;
&#xD;
          -  dyslexia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Canniesburn Regional Plastic Surgery and Burns Unit</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G4 0SF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3-D</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share</ipd_description>
  </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/NCT04444297
org study id: GN20HS287
nct id: NCT04444297
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Telemedicine will be used as standard practice during the Covid Pandemic, in order to reduce
      clinician exposure to patients and potential high viral load, and reduce patient footfall in
      a hospital caring for Covid patients. The 3D telemedicine uses multiple cameras in the clinic
      room which can reconstruct an image in 3 dimensions. This may give more information about a
      patient's condition, particularly in more visual specialties such as Plastic Surgery. The
      systems have hospital approval to be used for telemedicine, all equipment is CE marked. There
      are no data regarding the use of 3D telemedicine, but similar studies have been performed in
      many fields including orthopaedic surgery using 2D telemedicine (Buvik 2016). This study aims
      to provide non-clinical validations of the 3D telemedicine for usability, presence,
      satisfaction and reliability, using healthy volunteers only.
Study Methods The study will involve non-clinical validation with no patients and no
      interventions. The study will investigate usability, presence, satisfaction and reliability
      data for 3D telemedicine, and provide subjective feedback in the form of a semi-structured
      interview.

      Participants Healthy volunteers from the staff at Canniesburn Regional Plastic Surgery and
      Burns Unit, Glasgow Royal Infirmary and West Glasgow ACH, Greater Glasgow and Clyde.

      Inclusions and exclusion Healthy staff/students. Recruitment from all contacted, eligible
      participants will be recorded. Exclusion criteria include visual problems not correctable
      with glasses/dyslexia.

      Consent Participants will be consented in writing for inclusion in the study. The consent
      will specify that data may be recorded for research and further analysis by the research
      team, and be available for technical purposes by the research team's industrial partner

      Sample Size

      30-40 participants for Presence and Usability Questionnaires.

      Participants will examine other participants (where one acts as a "doctor" and one acts as a
      "patient") to provide indicators of usability, presence and task load index. All participants
      will assess other participants using the screening tasks below (estimated 10 mins maximum):

      Screening Tasks: asking "patient" to follow instructions Upper Limb: Functional screening
      upper limb - hands above head, brush teeth, hands behind back, pro-supination, wrist,
      prehension grips (power, span, pinch, key, tripod) Lower limb: Functional assessment of lower
      limb - walk, straight leg raise, take shoes off and examine sole of feet Head: examine worm's
      eye view of nose, side of nose and top of scalp.

      Performing a "task" Perform a form of physiotherapy or equivalent task (chosen at random)
      such as describing to patient the use of an anterolateral thigh flap for tumour
      reconstruction.

      Outcomes assessed: validated questionnaires, time taken to complete screening tasks, NASA
      task load index

      Randomisation Participants will be randomized to see "patients" in 3D or 2D first. This will
      be by blocked randomisation using a list and sealed envelopes.

      Outcome Measures

      Multiple measures of usability and presence will be used. This will be to form baseline data
      on the 3D telemedicine system (e.g. System usability score >68 is "good"), but also to
      determine the sensitivity of the various instruments to record overall satisfaction with the
      systems. This will help to determine the most appropriate instruments for the clinical
      validation.

      Mental Effort Rating Scale - single instrument Likert scale (Paas 1996) University of North
      Northway - 5 item - telemedicine questionnaire (Buvik 2016) System Usability Scale - 10 item
      scale - industry standard for usability of technology (Brooke 1986) Presence Questionnaire -
      29 item scale - assessment of presence in the system/virtual environment (PQ, Witmer 2005).

      Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine NASA TLX -
      task load index - 5 item modified scale - an indication of the ease of performing a task and
      frustration levels.

      Overall Telemedicine Satisfaction - VAS Semi Structured exit interview - will discuss with
      participant their views on the telemedicine system and how we can improve.

      Statistics and Analysis

      The values obtained for the different rating scales will be summarised, in order to provide a
      basis for future sample size calculations. With a sample size of 40, the confidence interval
      around an estimated standard deviation s would be 0.819 s to 1.284 s. With a sample size of
      50 it would be 0.835 s to 1.246 (Sim 2012).

      The relation between the various rating scales and overall telemedicine satisfaction will be
      assessed using linear mixed effects regression analysis predicting overall telemedicine
      satisfaction from the rating scale and type of telemedicine, including a random effect for
      participant.

      The research team will examine whether higher "presence" scores (on Presence Questionnaire)
      translate to less "frustration" (on NASA TLX), and whether this results in less error/time
      taken to complete tasks. This will be done using linear mixed effects regression analyses.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomised to 2D then 3D, or 3D then 3D telemedicine consultations
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigator and outcomes assessor will be blinded to method of telemedicine. It is not possible to blind participants.
measure: Presence Questionnaire
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Version 3 of PQ, 29 item rating scale of "presence". Witmer 2005
measure: University Hospital of North Northway Questionnaire
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient)
description: 5 item questionnaire on telemedicine quality. UNN Buvik 2016.
measure: Telehealth Usability Questionnaire
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: 21 item scale - assessment of telemedicine (TUQ, Parmanto 2016)
measure: System Usability Scale
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: 10 item industry standard technology scale
measure: Mental Effort Rating Scale
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Single instrument Likert scale (Paas 1996)
measure: NASA TLX
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Measure of task load index - 5 item modified scale - an indication of the ease of performing a task and frustration levels.
measure: Range of Motion measurements for elbow joint
time frame: Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) ]
description: Range of Motion measurements for elbow joint measured with face-to-face goniometer or on computer (telemedicine)
arm group label: 2D telemedicine
arm group type: Active Comparator
description: 2D telemedicine first, followed by crossover to 3D telemedicine with no washout period
arm group label: 3D Telemedicine
arm group type: Experimental
description: 3D telemedicine first, followed by crossover to 2D telemedicine with no washout period
intervention type: Other
intervention name: 3D Telemedicine
description: A consultation performed with a 3D form of telemedicine
arm group label: 3D Telemedicine
intervention type: Other
intervention name: 2D Telemedicine
description: A consultation performed with 2D (standard) telemedicine
arm group label: 2D telemedicine
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: No plan to share