AnemiaNCT03835364
Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia
An observational study of Anemia and Iron Deficiency Anemia, run by Entia Ltd at 1 site in United Kingdom.
Trial summary
Co-design of a home-based anaemia monitoring system with participants who have previous diagnosis of anaemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency Anemia
- What is being tested?
- Blood measurement
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2018to 15 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anyone over 18 years of age with a prior diagnosis of anaemia, who have the capability to sign consent for the themselves and commit to the requirements of the study.
Who may be able to join
- Prior diagnosis of anaemia
- Commitment to perform finger pricking to use the device every two weeks and complete 2 monthly questionnaires
- Participant's willingness to participate in 1 to 1 interviews and, or focus groups
- Understands and has a good level of spoken and written English
Who cannot join
- No prior diagnosis of anaemia
- Not committed to perform two weekly finger pricks to use device and complete 2 monthly questionnaires
- Unwilling to attend interviews and focus groups
- Doesn't have a good level of written and spoken English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Entia Ltd, Room G11, Screenworks, Highbury Grove, Highbury and Islington
London, N5 2EF
About this study
Co-design of a home-based anaemia monitoring system with participants who have previous diagnosis of anaemia.
Read the detailed description
The device/ monitoring system being developed is called Aptus home. Aptus home measures the haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these blood parameters, participants are able to monitor anaemia in participants' homes.
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, Iron Deficiency Anemia
- Being tested
- Blood measurement
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
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 the Aptus Home, anaemia home monitoring system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative capture of user feedback- Questionnaires
User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.
Measured: 14 months
Qualitative capture of user feedback- focus groups
User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start13 Apr 2018
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835364
- Sponsor's protocol ID
- IRAS: 233542
- Status last verified
- Feb 2021
- First submitted
- 27 Dec 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia
- ClinicalTrials.gov ID
- NCT03835364
- Acronym / sponsor ID
- IRAS: 233542
- Conditions
- Anemia, Iron Deficiency Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 8 Feb 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 anaemia monitoring system with participants who have previous diagnosis of anaemia.
Detailed description
The device/ monitoring system being developed is called Aptus home. Aptus home measures the haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these blood parameters, participants are able to monitor anaemia in participants' homes.
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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anyone over 18 years of age with a prior diagnosis of anaemia, who have the capability to sign consent for the themselves and commit to the requirements of the study.
Key inclusion criteria (4 listed)
- Prior diagnosis of anaemia
- Commitment to perform finger pricking to use the device every two weeks and complete 2 monthly questionnaires
- Participant's willingness to participate in 1 to 1 interviews and, or focus groups
- Understands and has a good level of spoken and written English
Key exclusion criteria (4 listed)
- No prior diagnosis of anaemia
- Not committed to perform two weekly finger pricks to use device and complete 2 monthly questionnaires
- Unwilling to attend interviews and focus groups
- Doesn't have a good level of written and spoken English
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 the Aptus Home, anaemia home monitoring system. | Device | – |
Primary outcome
Qualitative capture of user feedback- Questionnaires
Time frame: 14 months
User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.
Qualitative capture of user feedback- focus groups
Time frame: 14 months
User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring 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: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Iron Deficiency Anemia, 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 4 inclusion and 4 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?
Qualitative capture of user feedback- Questionnaires (time frame: 14 months). The study lists 2 primary outcomes in all. 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.