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Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia

Sponsor
Entia Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03835364
Collaborator
(none)
25
Enrollment
1
Location
33.1
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Co-design of a home-based anaemia monitoring system with participants who have previous diagnosis of anaemia.

Condition or Disease Intervention/Treatment Phase
  • Device: Blood measurement

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
25 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia
Actual Study Start Date :
Apr 13, 2018
Actual Primary Completion Date :
Jan 15, 2021
Actual Study Completion Date :
Jan 15, 2021

Outcome Measures

Primary Outcome Measures

  1. Qualitative capture of user feedback- Questionnaires [14 months]

    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.

  2. Qualitative capture of user feedback- focus groups [14 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Prior diagnosis of anaemia

  • Commitment to perform finger pricking to use the device every two weeks and complete 2 monthly questionnaires

  • Participant's willingness to participate in 1 to 1 interviews and, or focus groups

  • Understands and has a good level of spoken and written English

Exclusion Criteria:

  • No prior diagnosis of anaemia

  • Not committed to perform two weekly finger pricks to use device and complete 2 monthly questionnaires

  • Unwilling to attend interviews and focus groups

  • Doesn't have a good level of written and spoken English

Contacts and Locations

Locations

Site City State Country Postal Code
1 Entia Ltd, Room G11, Screenworks, Highbury Grove, Highbury and Islington London United Kingdom N5 2EF

Sponsors and Collaborators

  • Entia Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Entia Ltd
ClinicalTrials.gov Identifier:
NCT03835364
Other Study ID Numbers:
  • IRAS: 233542
First Posted:
Feb 8, 2019
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency

Study Results

No Results Posted as of Feb 9, 2021