Chronic Kidney DiseasesNCT04137315
Project Aura: Home Trial of a Home-based Monitoring Service
An observational study of Chronic Kidney Diseases, run by Entia Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Blood measurement
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2020to 29 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be recruited from the study site.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
About this study
Official title: 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.
Read the 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
- Being tested
- Blood measurement
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood measurementDevice
Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative capture of measurement system
Data collection for evaluation of measurement system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start14 Feb 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunil Bhandari, FHEA, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137315
- Sponsor's protocol ID
- IRAS: 272300
- Status last verified
- Feb 2021
- First submitted
- 22 Oct 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Aura: Data Collection for a Home Monitoring Solution for Patients With Anaemia to Evaluate Delivery of Treatment
- ClinicalTrials.gov ID
- NCT04137315
- Acronym / sponsor ID
- IRAS: 272300
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited from the study site.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood measurementSingle fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system. | Device | – |
Primary outcome
Quantitative capture of measurement system
Time frame: 6 months
Data collection for evaluation of measurement system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Bhandari, FHEA principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Entia Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative capture of measurement system (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.