Project Aura: Co-design of a Home-based Monitoring Service

Withdrawn

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Device: Blood measurement

• Registration Number: NCT04112615
• Lead Sponsor: Entia Ltd

Brief Summary

Co-design of a home-based haemoglobin monitoring system with participants with anaemia of chronic kidney disease.

Detailed Description

The device/monitoring system being developed measures the haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these blood parameter, participants are able to monitor their haemoglobin level at home.

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 Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-02
• Study Start: 2020-02-17
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthcare professionals	Blood measurement	Healthcare professionals come in to give feedback on the device and the system, from what results they would like to see and their concerns about patients using it.
Patients and/or carers	Blood measurement	Patients and/or their nominated carers come in to give feedback on the device and the system as a whole, from usability to design.

Primary Outcome Measures

Name	Time	Method
Qualitative capture of user feedback- focus groups	12 months	User feedback gathered from participants using the blood measurement device will be used to inform the changes necessary to develop a successful home-based haemoglobin monitoring system.; Feedback will be analysed based on framework analysis.

Trial Locations

Locations (1)

Hull University Teaching Hospitals NHS Trust; 🇬🇧 Hull, United Kingdom