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NCT03835364 Clinical Trial

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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03835364
Other study ID # IRAS: 233542
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 13, 2018
Est. completion date January 15, 2021

Study information
Verified date February 2021
Source Entia Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date January 15, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Blood measurement
Single fingerprick to measure haemoglobin and haematocrit measurements using the Aptus Home, anaemia home monitoring system.

Locations
Country Name City State
United Kingdom Entia Ltd, Room G11, Screenworks, Highbury Grove, Highbury and Islington London

Sponsors (1)
Lead Sponsor Collaborator
Entia Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative capture of user feedback- Questionnaires 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. 14 months
Primary Qualitative capture of user feedback- focus groups 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. 14 months
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