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

NCT ID: NCT04137315

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-14
• Study Completion Date: 2021-01-29

Brief Summary

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

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Blood measurement

Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Entia Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunil Bhandari, FHEA

Role: PRINCIPAL_INVESTIGATOR

Hull University Teaching Hospitals NHS Trust

Locations

Hull University Teaching Hospitals NHS Trust

Hull, , United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS: 272300

Identifier Type: -

Identifier Source: org_study_id