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

Project Aura: Co-design of a Home-based Monitoring Service for Patients With Chronic Kidney Disease

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

Study Overview

• Status: Withdrawn
• Conditions: Anemia of Chronic Kidney Disease
• Intervention / Treatment: Device: Blood measurement

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 Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Hull University Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the study site.

Description

Inclusion criteria:

For patients:

• Adequate English to participate in focus groups without an interpreter
• Patients of the study site who are currently undergoing treatment for anaemia of CKD
• Patients willing to participate in at least one or more 60-minute and ideally 90-minute focus groups at the designated study location, time and date.
• Patients capable of providing informed consent before attending the first focus group

For carers:

• Should be the primary carer nominated by a patient who fulfils the inclusion criteria, this includes parents of affected children
• Should be willing to participate in at least 60-minute and ideally 90-minute focus groups at the designated study location, time and date.
• Carers can only participate in the study with the patient he/she is caring for. The patient has also to be involved in the study
• Carers need to be capable of providing informed consent before attending the first focus group

For healthcare professionals:

• All clinicians need to be current employees of the study site
• Doctors need to be employed at Specialist Registrar, Fellow or Consultant Level
• Nurses of all grades are invited to participate but ideally need to have had some involvement in the outpatient care of CKD patients with anaemia

All participants:

• Should be willing to have the session's recorded audio, transcripts and analysed data from the focus groups shared with Entia.
• should be willing to attend multiple 60 to 90 minute focus groups.
• should be willing for unidentifiable photos and video footage to be taken during the interview.
• Participants attending focus groups later in the development process must be comfortable consenting to finger prick testing/ assessing the ease of use of the test disposable

Exclusion criteria:

Patients:

• Does not have adequate English to participate in focus group interviews without an interpreter.
• Patients of the study site who are not currently undergoing treatment or have previously undergone treatment within the past 12 months.
• Patients not willing to participate in at least 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.
• Participant not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the focus group interview.

For carers:

• Is not the nominated primary carer of a patient who fulfils the inclusion criteria, this includes parents of affected children
• Not paired with a patient that is involved in the study
• Carers not willing to participate in at least a 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.

For healthcare professionals:

None.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients and/or carers; Patients and/or their nominated carers come in to give feedback on the device and the system as a whole, from usability to design.	Device: Blood measurement; Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.
Healthcare professionals; 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.	Device: Blood measurement; Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative capture of user feedback- focus groups	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.	12 months

Collaborators and Investigators

• Sponsor: Entia Ltd
• Investigators: Principal Investigator: Sunil Bhandari, FHEA, Hull University Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 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: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRAS: 271364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only within clinical team involved in this study and design and research teams in Entia.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No