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

NCT ID: NCT03835364

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-13

Study Completion Date

2021-01-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Anemia Iron Deficiency Anemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Blood measurement

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Entia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IRAS: 233542

Identifier Type: -

Identifier Source: org_study_id

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