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

February 8, 2021 updated by: Entia Ltd
Co-design of a home-based anaemia monitoring system with participants who have previous diagnosis of anaemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, N5 2EF
        • Entia Ltd, Room G11, Screenworks, Highbury Grove, Highbury and Islington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anyone over 18 years of age with a prior diagnosis of anaemia, who have the capability to sign consent for the themselves and commit to the requirements of the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 months
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.
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 13, 2018

Primary Completion (ACTUAL)

January 15, 2021

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

February 7, 2019

First Posted (ACTUAL)

February 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS: 233542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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