<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/NCT02207166</url>
  </required_header>
  <id_info>
    <org_study_id>201406066RINB</org_study_id>
    <nct_id>NCT02207166</nct_id>
  </id_info>
  <brief_title>Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning</brief_title>
  <acronym>IPEOHUBPMBUR</acronym>
  <official_title>Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning (IPEOHUBPMBUR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medical devices are designed and manufactured by subjective design process that was only&#xD;
      based on engineers' direct concepts to essential principles sets for the device. A home user&#xD;
      may not easily use or operate the piece of medical device through the interfacing components&#xD;
      as the designer's expected such as the meaning when pushing a button or switching a knob,&#xD;
      even the required procedure needed when a certain display shown to fulfill some knowledge&#xD;
      dependent judgment. In addition, the incompatible interfacing designed communication between&#xD;
      a user and the device may cause possible errors that may trigger further negative&#xD;
      consequences during the use of the device to a innocent home user.&#xD;
&#xD;
      The aim of this research is to closely understand the consequent results of human factor&#xD;
      engineering or usability engineering practices of various types or models of marketed&#xD;
      home-use blood pressure monitors (BPM) in real use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this research is to closely understand the consequent results of human factor&#xD;
      engineering or usability engineering practices of various types or models of marketed&#xD;
      home-use blood pressure monitors (BPM) in real use. Participants of the intended user&#xD;
      population interact with marketed BPMs in research to assess ease of learning, ease of use,&#xD;
      effectiveness and efficiency of use, memorability, safety, and/or user appeal among the many&#xD;
      possible attributes of interest. With these understanding and analysis of human factors&#xD;
      engineering / usability engineering (HFE/UE) practiced status, it can help manufacturers to&#xD;
      capture the required and diversified HFE/UE essences with the minimum or limited professional&#xD;
      technical resources in hand some more efficiently.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total steps of incorrect operations</measure>
    <time_frame>During the 40-60 mins osbervation period</time_frame>
    <description>Possible errors may cause negative outcomes to a home-user when he/she uses the BPM. The principal concept of &quot;usability&quot; is that a good usability designed BPM is easy to operate it as the device designer expected a home-user to perform in real use.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>user group</arm_group_label>
    <description>volunteers who are willing to receive 40 minutes video monitoring and questionnaires while operation a electronic blood pressure measuring machines.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults who are able to operate general healthcare devices (eg thermometer, electronic blood&#xD;
        pressure measures)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 20-75 years&#xD;
&#xD;
          -  capable of operating the blood pressure measure machine provided by the study&#xD;
&#xD;
          -  willing to operate the provided device and accept video taping from shoulder and below&#xD;
&#xD;
          -  willing to fill the study questionnaire and to provide feedback after use of the&#xD;
             device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vulnerable population (including pregnant woman, disabled, etc)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ding-Cheng Chan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>March 17, 2015</last_update_submitted>
  <last_update_submitted_qc>March 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypertension</keyword>
  <keyword>device</keyword>
  <keyword>errors</keyword>
  <keyword>human factor engineering</keyword>
  <keyword>usability engineering</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT02207166
org study id: 201406066RINB
nct id: NCT02207166
lead sponsor: 
has dmc: No
Medical devices are designed and manufactured by subjective design process that was only
      based on engineers' direct concepts to essential principles sets for the device. A home user
      may not easily use or operate the piece of medical device through the interfacing components
      as the designer's expected such as the meaning when pushing a button or switching a knob,
      even the required procedure needed when a certain display shown to fulfill some knowledge
      dependent judgment. In addition, the incompatible interfacing designed communication between
      a user and the device may cause possible errors that may trigger further negative
      consequences during the use of the device to a innocent home user.

      The aim of this research is to closely understand the consequent results of human factor
      engineering or usability engineering practices of various types or models of marketed
      home-use blood pressure monitors (BPM) in real use.
The aim of this research is to closely understand the consequent results of human factor
      engineering or usability engineering practices of various types or models of marketed
      home-use blood pressure monitors (BPM) in real use. Participants of the intended user
      population interact with marketed BPMs in research to assess ease of learning, ease of use,
      effectiveness and efficiency of use, memorability, safety, and/or user appeal among the many
      possible attributes of interest. With these understanding and analysis of human factors
      engineering / usability engineering (HFE/UE) practiced status, it can help manufacturers to
      capture the required and diversified HFE/UE essences with the minimum or limited professional
      technical resources in hand some more efficiently.
observational model: Case-Only
time perspective: Prospective
measure: Total steps of incorrect operations
time frame: During the 40-60 mins osbervation period
description: Possible errors may cause negative outcomes to a home-user when he/she uses the BPM. The principal concept of "usability" is that a good usability designed BPM is easy to operate it as the device designer expected a home-user to perform in real use.
arm group label: user group
description: volunteers who are willing to receive 40 minutes video monitoring and questionnaires while operation a electronic blood pressure measuring machines.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ding-Cheng Chan, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypertension