Status:
WITHDRAWN
Project Aura: Co-design of a Home-based Monitoring Service
Lead Sponsor:
Entia Ltd
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
16+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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:
- 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
- Exclusion criteria:
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
February 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04112615
Start Date
February 17 2020
End Date
June 15 2020
Last Update
February 10 2021
Active Locations (1)
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1
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ