Status:
COMPLETED
Project Aura: Home Trial of a Home-based Monitoring Service
Lead Sponsor:
Entia Ltd
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 29 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04137315
Start Date
February 14 2020
End Date
January 29 2021
Last Update
February 9 2021
Active Locations (1)
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1
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ