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Project Aura: Home Trial of a Home-based Monitoring Service | Clinical Trials | Clareo Health

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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

NCT04137315•Entia Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (1)

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

Key Dates

Start Date

February 14, 2020

Primary Completion Date

January 29, 2021

Completion Date

January 29, 2021

Last Updated

February 9, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Kidney Diseases

Interventions

Blood measurement

DEVICE

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

NCT04592640

Chronic Kidney DiseasesCalciphylaxis+4 more

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RECRUITINGNA

Handgrip Exercise Training and CKD

NCT07094906

Chronic Kidney Diseases

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

Handgrip Exercise Training and CKD

Eye-Brain-Kidney in CKD

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)

The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect