Project Aura: Home Trial of a Home-based Monitoring Service

Project Aura: Data Collection for a Home Monitoring Solution for Patients With Anaemia to Evaluate Delivery of Treatment

This is a data collection study to compare diagnostic methods of a prototype of a home monitoring device against laboratory testing in the hospital.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• 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 parameters, 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 data collection study to evaluate the performance of the prototype.

• Study Type: Observational
• Enrollment (Actual): 10

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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the study site.

Description

Inclusion Criteria:

• Age ≥ 18 years of age.
• Adequate english to participate in training sessions and use the analyser.
• Patients of the study site who are currently undergoing treatment for anaemia of CKD with ESAs.
• Patients who are not pregnant.
• Patients who do not have a bleeding disorder.
• Patients willing to perform self-tests 2-3 times a week.
• Patients capable of providing informed consent before attending training.
• Patients or patients with a carer capable of fine manipulation of the device and its consumables.
• Patients or patients with a carer who own a smartphone which can download the app related to this study.
• Patients or patients with carers who do not have eyesight limitations to be able to read the instructions on the screen of the prototype device.
• Patients who are not expected to have to start dialysis treatment during the course of this study.

Exclusion Criteria:

• Does not have adequate English to participate in training or use the analyser without an interpreter.
• Patients of the study site who are not currently undergoing anaemia treatment with ESAs.
• Patients of the study site not willing to perform self-tests 2-3 times a week.
• Patients of the study site not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the trial.
• Patients who are pregnant.
• Patients with a bleeding disorder.
• Patients or their nominated carers who are not capable of fine manipulation of the device and its consumables.
• Neither patients or their nominated carers do not own a smartphone which can install the app related to this study.
• Patients or their nominated carers with eyesight limitations to not be able to read the instructions on the screen of the prototype device.
• Patients who are expected to start dialysis treatment during the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative capture of measurement system	Data collection for evaluation of measurement system	6 months

Collaborators and Investigators

• Sponsor: Entia Ltd
• Investigators: Principal Investigator: Sunil Bhandari, FHEA, Hull University Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): January 29, 2021
• Study Completion (Actual): January 29, 2021

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 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: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRAS: 272300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data will be pseudonymous (shared with the research & clinical team). Participant data is only seen by the research nurse for contacting, updating and travel reimbursement purposes.

Drug and device information, study documents

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