<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/NCT03808246</url>
  </required_header>
  <id_info>
    <org_study_id>2017_16</org_study_id>
    <secondary_id>2017-A02847-46</secondary_id>
    <nct_id>NCT03808246</nct_id>
  </id_info>
  <brief_title>Detection of Usability Errors of a Medical Device Zeneo®</brief_title>
  <official_title>Detection of Usability Errors of a Medical Device Zeneo®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Agency, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      The research addresses the question of the number of participants needed to identify as many&#xD;
      usability-induced errors as possible in the context of summative usability tests. The&#xD;
      research addresses also the impact of the ecological validity of the test environment on the&#xD;
      number of usability-induced errors uncovered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to determine how many participants must be recruited to detect 95% of the&#xD;
      anticipated use errors, two groups of participants (naives or informed to the type of device&#xD;
      under evaluation) will take part to usability test of a demo version of an auto injector pen&#xD;
      in one of two test environments (realistic or laboratory-like). The combination of the 2&#xD;
      types of users and the two types of environment composes 4 arms.&#xD;
&#xD;
      By default, 15 participants will be recruited per arm (in conformity with usual guidelines).&#xD;
      If, in a given group, 95% of anticipated errors are detected, no more participants will be&#xD;
      recruited in the arm. Otherwise, 5 other participants will be recruited till the 95%&#xD;
      threshold is reached with a maximum of 40 participants per group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2019</start_date>
  <completion_date type="Actual">December 9, 2019</completion_date>
  <primary_completion_date type="Actual">December 9, 2019</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>
    <intervention_model_description>2 profiles of participants (naïves vs. informed) x 2 types of test environment (realistic vs. laboratory-like).&#xD;
Each participant, depending on her/his profile is assigned to one &quot;profile of participant&quot; group and randomly to one &quot;type of test environment&quot; group.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>For each arm, number of participants needed to uncover 95% of the use errors known</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of use errors uncovered per participant</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants who detected a given error</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of unanticipated errors detected</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>naive/realistic environment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the &quot;realistic environment&quot; condition of simulation.&#xD;
The intervention is &quot;using the demo version of a self-injector pen&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>informed/realistic environment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the &quot;realistic environment&quot; condition of simulation.&#xD;
The intervention is &quot;using the demo version of a self-injector pen&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>informed/laboratory-like environment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the &quot;laboratory-like environment&quot; condition of simulation.&#xD;
The intervention is &quot;using the demo version of a self-injector pen&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>naive/laboratory-like environment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the &quot;laboratory-like environment&quot; condition of simulation.&#xD;
The intervention is &quot;using the demo version of a self-injector pen&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>using the demo version of a self-injector pen</intervention_name>
    <description>Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.</description>
    <arm_group_label>informed/laboratory-like environment</arm_group_label>
    <arm_group_label>informed/realistic environment</arm_group_label>
    <arm_group_label>naive/laboratory-like environment</arm_group_label>
    <arm_group_label>naive/realistic environment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Two types of participants (healthy people) will be recruited: participants informed about&#xD;
        auto-injector pens (BUT NOT PATIENTS) and participants naïves on this topic.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to use the device&#xD;
&#xD;
          -  Without previous experience of anaphylactic shock&#xD;
&#xD;
          -  Not taking a psychotropic drug&#xD;
&#xD;
          -  Without hearing impairment&#xD;
&#xD;
          -  Covered by social security&#xD;
&#xD;
          -  Who signed the consent form and the information letter&#xD;
&#xD;
          -  Who agree to conform to the procedure of the study -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Vulnerable Persons&#xD;
&#xD;
          -  Persons under administrative supervision&#xD;
&#xD;
          -  Persons who are subject to a judicial protection measure&#xD;
&#xD;
          -  Persons who do not understand correctly French.&#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>Romaric Marcilly, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Usability Lab of CIC IT 1403</name>
      <address>
        <city>Lille</city>
        <state>Haut De France</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03808246
org study id: 2017_16
secondary id: 2017-A02847-46
nct id: NCT03808246
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research addresses the question of the number of participants needed to identify as many
      usability-induced errors as possible in the context of summative usability tests. The
      research addresses also the impact of the ecological validity of the test environment on the
      number of usability-induced errors uncovered.
In order to determine how many participants must be recruited to detect 95% of the
      anticipated use errors, two groups of participants (naives or informed to the type of device
      under evaluation) will take part to usability test of a demo version of an auto injector pen
      in one of two test environments (realistic or laboratory-like). The combination of the 2
      types of users and the two types of environment composes 4 arms.

      By default, 15 participants will be recruited per arm (in conformity with usual guidelines).
      If, in a given group, 95% of anticipated errors are detected, no more participants will be
      recruited in the arm. Otherwise, 5 other participants will be recruited till the 95%
      threshold is reached with a maximum of 40 participants per group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 profiles of participants (naïves vs. informed) x 2 types of test environment (realistic vs. laboratory-like).
Each participant, depending on her/his profile is assigned to one "profile of participant" group and randomly to one "type of test environment" group.
primary purpose: Other
masking: None (Open Label)
measure: For each arm, number of participants needed to uncover 95% of the use errors known
time frame: through study completion, an average of 6 months
measure: number of use errors uncovered per participant
time frame: through study completion, an average of 6 months
measure: number of participants who detected a given error
time frame: through study completion, an average of 6 months
measure: number of unanticipated errors detected
time frame: through study completion, an average of 6 months
arm group label: naive/realistic environment
arm group type: Experimental
description: This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen".
arm group label: informed/realistic environment
arm group type: Experimental
description: This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen".
arm group label: informed/laboratory-like environment
arm group type: Experimental
description: This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen".
arm group label: naive/laboratory-like environment
arm group type: Experimental
description: This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation.
The intervention is "using the demo version of a self-injector pen".
intervention type: Other
intervention name: using the demo version of a self-injector pen
description: Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
arm group label: informed/laboratory-like environment
arm group label: informed/realistic environment
arm group label: naive/laboratory-like environment
arm group label: naive/realistic environment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Romaric Marcilly, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor