<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/NCT03835364</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS: 233542</org_study_id>
    <nct_id>NCT03835364</nct_id>
  </id_info>
  <brief_title>Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia</brief_title>
  <official_title>Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Entia Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Entia Ltd</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>
      Co-design of a home-based anaemia monitoring system with participants who have previous&#xD;
      diagnosis of anaemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The device/ monitoring system being developed is called Aptus home. Aptus home measures the&#xD;
      haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these&#xD;
      blood parameters, participants are able to monitor anaemia in participants' homes.&#xD;
&#xD;
      The use of the device will take place in the participant's home to simulate what the&#xD;
      investigators believe will be the ideal location for people who would prefer to self-manage&#xD;
      their condition.&#xD;
&#xD;
      This study is a unique opportunity to gain feedback on the future design and development of a&#xD;
      home-based monitoring system through user evaluation. As this is an adaptive/ iterative study&#xD;
      design, this will give the Sponsor the opportunity to make changes to the user interface and&#xD;
      user platform based on the feedback received from the end user.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2018</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative capture of user feedback- Questionnaires</measure>
    <time_frame>14 months</time_frame>
    <description>User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative capture of user feedback- focus groups</measure>
    <time_frame>14 months</time_frame>
    <description>User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.</description>
  </primary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Anemia</condition>
  <condition>Iron Deficiency Anemia</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood measurement</intervention_name>
    <description>Single fingerprick to measure haemoglobin and haematocrit measurements using the Aptus Home, anaemia home monitoring system.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anyone over 18 years of age with a prior diagnosis of anaemia, who have the capability to&#xD;
        sign consent for the themselves and commit to the requirements of the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior diagnosis of anaemia&#xD;
&#xD;
          -  Commitment to perform finger pricking to use the device every two weeks and complete 2&#xD;
             monthly questionnaires&#xD;
&#xD;
          -  Participant's willingness to participate in 1 to 1 interviews and, or focus groups&#xD;
&#xD;
          -  Understands and has a good level of spoken and written English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior diagnosis of anaemia&#xD;
&#xD;
          -  Not committed to perform two weekly finger pricks to use device and complete 2 monthly&#xD;
             questionnaires&#xD;
&#xD;
          -  Unwilling to attend interviews and focus groups&#xD;
&#xD;
          -  Doesn't have a good level of written and spoken English&#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>
  <location>
    <facility>
      <name>Entia Ltd, Room G11, Screenworks, Highbury Grove, Highbury and Islington</name>
      <address>
        <city>London</city>
        <zip>N5 2EF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03835364
org study id: IRAS: 233542
nct id: NCT03835364
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Co-design of a home-based anaemia monitoring system with participants who have previous
      diagnosis of anaemia.
The device/ monitoring system being developed is called Aptus home. Aptus home measures the
      haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these
      blood parameters, participants are able to monitor anaemia in participants' homes.

      The use of the device will take place in the participant's home to simulate what the
      investigators believe will be the ideal location for people who would prefer to self-manage
      their condition.

      This study is a unique opportunity to gain feedback on the future design and development of a
      home-based monitoring system through user evaluation. As this is an adaptive/ iterative study
      design, this will give the Sponsor the opportunity to make changes to the user interface and
      user platform based on the feedback received from the end user.
observational model: Case-Control
time perspective: Prospective
measure: Qualitative capture of user feedback- Questionnaires
time frame: 14 months
description: User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.
measure: Qualitative capture of user feedback- focus groups
time frame: 14 months
description: User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.
intervention type: Device
intervention name: Blood measurement
description: Single fingerprick to measure haemoglobin and haematocrit measurements using the Aptus Home, anaemia home monitoring system.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: Undecided