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

February 8, 2021 updated by: Entia Ltd

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

Intervention / Treatment

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

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

Study Locations

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

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

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

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
Quantitative capture of measurement system
Time Frame: 6 months
Data collection for evaluation of measurement system
6 months

Collaborators and Investigators

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

Sponsor

Entia Ltd

Investigators

  • Principal Investigator: Sunil Bhandari, FHEA, Hull University Teaching Hospitals NHS Trust

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)

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

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

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.

Subscribe