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Completed

NCT Number: NCT03835364

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Entia Ltd, Room G11, Screenworks, Highbury Grove, Highbury and Islington

London, N5 2EF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood measurement

Device

Single fingerprick to measure haemoglobin and haematocrit measurements using the Aptus Home, anaemia home monitoring system.

Primary outcomes

  1. Qualitative capture of user feedback- Questionnaires

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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