Project Aura: Co-design of a Home-based Monitoring Service

NCT04112615 | Withdrawn DMC

• 1 other identifier: IRAS: 271364
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Co-design of a home-based haemoglobin monitoring system with participants with anaemia of chronic kidney disease.

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (2)

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.

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.

Device: Blood measurement

Interventions

Blood measurement DEVICE

Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.

Healthcare professionals; Patients and/or carers

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the study site.

You may qualify if:

• 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 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

Study Officials

• Sunil Bhandari, FHEA

  Hull University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: February 17, 2020
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)