Anemia of Chronic Kidney DiseaseNCT04112615
Project Aura: Co-design of a Home-based Monitoring Service
An observational study of Anemia of Chronic Kidney Disease, run by Entia Ltd at 1 site in United Kingdom.
Trial summary
Co-design of a home-based haemoglobin monitoring system with participants with anaemia of chronic kidney disease. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Blood measurement
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2020to 15 Jun 2020
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The participants will be recruited from the study site.
Who may be able to join
- For patients:
- Adequate English to participate in focus groups without an interpreter
- Patients of the study site who are currently undergoing treatment for anaemia of CKD
- Patients willing to participate in at least one or more 60-minute and ideally 90-minute focus groups at the designated study location, time and date.
- Patients capable of providing informed consent before attending the first focus group
- For carers:
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- Should be the primary carer nominated by a patient who fulfils the inclusion criteria, this includes parents of affected children
- Should be willing to participate in at least 60-minute and ideally 90-minute focus groups at the designated study location, time and date.
- Carers can only participate in the study with the patient he/she is caring for. The patient has also to be involved in the study
- Carers need to be capable of providing informed consent before attending the first focus group
- For healthcare professionals:
- All clinicians need to be current employees of the study site
- Doctors need to be employed at Specialist Registrar, Fellow or Consultant Level
- Nurses of all grades are invited to participate but ideally need to have had some involvement in the outpatient care of CKD patients with anaemia
- All participants:
- Should be willing to have the session's recorded audio, transcripts and analysed data from the focus groups shared with Entia.
- should be willing to attend multiple 60 to 90 minute focus groups.
- should be willing for unidentifiable photos and video footage to be taken during the interview.
- Participants attending focus groups later in the development process must be comfortable consenting to finger prick testing/ assessing the ease of use of the test disposable
Who cannot join
- Patients:
- Does not have adequate English to participate in focus group interviews without an interpreter.
- Patients of the study site who are not currently undergoing treatment or have previously undergone treatment within the past 12 months.
- Patients not willing to participate in at least 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.
- Participant not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the focus group interview.
- For carers:
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- Is not the nominated primary carer of a patient who fulfils the inclusion criteria, this includes parents of affected children
- Not paired with a patient that is involved in the study
- Carers not willing to participate in at least a 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.
- For healthcare professionals:
- None.
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: Co-design of a Home-based Monitoring Service for Patients With Chronic Kidney Disease
Co-design of a home-based haemoglobin monitoring system with participants with anaemia of chronic kidney disease.
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 parameter, 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 unique opportunity to gain feedback on the future design and development of a home-based monitoring system through user evaluation. As this is an adaptive/ iterative study design, this will give the Sponsor the opportunity to make changes to the user interface and user platform based on the feedback received from the end user.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Blood measurement
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients and/or carers | Patients and/or their nominated carers come in to give feedback on the device and the system as a whole, from usability to design. Receives: Device: Blood measurement | |
| Healthcare professionals | Healthcare professionals come in to give feedback on the device and the system, from what results they would like to see and their concerns about patients using it. Receives: Device: Blood measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative capture of user feedback- focus groups
User feedback gathered from participants using the blood measurement device will be used to inform the changes necessary to develop a successful home-based haemoglobin monitoring system.
Feedback will be analysed based on framework analysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start17 Feb 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112615
- Sponsor's protocol ID
- IRAS: 271364
- Status last verified
- Feb 2021
- First submitted
- 1 Oct 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only within clinical team involved in this study and design and research teams in Entia.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Aura: Co-design of a Home-based Monitoring Service for Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04112615
- Acronym / sponsor ID
- IRAS: 271364
- Conditions
- Anemia of Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 2 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.
Co-design of a home-based haemoglobin monitoring system with participants with anaemia of chronic kidney disease.
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 parameter, 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 unique opportunity to gain feedback on the future design and development of a home-based monitoring system through user evaluation. As this is an adaptive/ iterative study design, this will give the Sponsor the opportunity to make changes to the user interface and user platform based on the feedback received from the end user.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients and/or carers | – | Device: Blood measurementPatients and/or their nominated carers come in to give feedback on the device and the system as a whole, from usability to design. |
| Healthcare professionals | – | Device: Blood measurementHealthcare professionals come in to give feedback on the device and the system, from what results they would like to see and their concerns about patients using it. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants will be recruited from the study site.
Key inclusion criteria (19 listed)
- Adequate English to participate in focus groups without an interpreter
- Patients of the study site who are currently undergoing treatment for anaemia of CKD
- Patients willing to participate in at least one or more 60-minute and ideally 90-minute focus groups at the designated study location, time and date.
- Patients capable of providing informed consent before attending the first focus group
- Should be the primary carer nominated by a patient who fulfils the inclusion criteria, this includes parents of affected children
Key exclusion criteria (11 listed)
- Does not have adequate English to participate in focus group interviews without an interpreter.
- Patients of the study site who are not currently undergoing treatment or have previously undergone treatment within the past 12 months.
- Patients not willing to participate in at least 60-minute and ideally 90-minute focus group discussion at the designated study location, time and date.
- Participant not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the focus group interview.
- Is not the nominated primary carer of a patient who fulfils the inclusion criteria, this includes parents of affected children
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 | Healthcare professionals, Patients and/or carers |
Primary outcome
Qualitative capture of user feedback- focus groups
Time frame: 12 months
User feedback gathered from participants using the blood measurement device will be used to inform the changes necessary to develop a successful home-based haemoglobin monitoring system. Feedback will be analysed based on framework analysis.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Yes. Only within clinical team involved in this study and design and research teams in Entia.
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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 Hospital
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 Anemia of Chronic Kidney Disease, 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 19 inclusion and 11 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: withdrawn, as of the sponsor's last update on 10 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 was withdrawn before enrolling participants, so there are no results.
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?
Qualitative capture of user feedback- focus groups (time frame: 12 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 10 Feb 2021.