About this trial
The BloodTrackR Usability and Concordance Study (BUCS) is evaluating a novel home-based blood collection device and companion mobile application for people with rheumatoid arthritis. Participants will use the BloodTrackR device to collect a finger-prick blood sample at home and complete symptom assessments through the app.
The study will assess how easy the device and app are to use, whether participants can successfully collect high-quality blood samples outside of a healthcare setting, and how closely the results compare with standard venous blood samples collected by a phlebotomist. Findings will help determine the potential of BloodTrackR to support remote monitoring and reduce reliance on NHS phlebotomy services.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals living with rheumatoid arthritis, who attend community groups or rheumatoid arthritis charity groups
Aged 18 years or older
Able to understand written and spoken English
Individuals who have the capacity to consent
Disqualifiers
Participants <18years
Participants taking antibiotics/antivirals
No access to WiFi or a smartphone/tablet
Trial population
The study population will consist of approximately 20 adults aged 18 years and older with a confirmed diagnosis of rheumatoid arthritis living in or around Derry/Londonderry, Northern Ireland. Participants must be able to understand written and spoken English and have access to WiFi and a smartphone or tablet. Participants will be recruited through rheumatology patient organisations, support groups, community networks, and research recruitment platforms to evaluate the usability, acceptability, and concordance of the BloodTrackR home blood collection platform.
Trial design
Cohort
Prospective
Treatments tested in this trial
BloodTrackR - Home Blood Collection Platform
DeviceA home-based blood collection device and mobile application that enables remote blood sampling, symptom tracking, temperature monitoring, and sample traceability.
Treatment groups
Trial outcomes
Primary outcomes
Questionnaire to assess usability of the BloodTrackR Home Blood Collection Platform
Usability of the BloodTrackR device and companion mobile application will be assessed using a study-specific usability questionnaire completed after device use. Participants will indicate whether each step of the blood collection procedure was successfully completed, completed with issues, or not completed, and will provide an overall usability rating on a scale of 0 to 10. Higher scores indicate greater usability and user satisfaction.
Secondary outcomes
Post-Procedure Semi-Structured Interview on BloodTrackR User Experience
Participant experience of using the BloodTrackR device and companion mobile application will be explored through a post-procedure semi-structured interview. Interview questions will explore ease of use, acceptability, perceived benefits, barriers to use, and suggestions for improvement. The responses will be summarised descriptively across participants.
Concordance Between BloodTrackR device and Venous CRP Measurements
Comparison of C-reactive protein (CRP) concentrations obtained from blood samples collected using BloodTrackR and paired venous blood samples analysed using standard laboratory methods.
Successful Home Blood Sample Collection Rate
Proportion of participants able to successfully collect and return a blood sample using the BloodTrackR device without assistance.
Estimated Patient Time Associated With Blood Collection
A preliminary health economic assessment will compare BloodTrackR with standard NHS phlebotomy pathways. Estimated patient time associated with blood collection, including travel, waiting, and clinic time, comparing BloodTrackR with standard NHS phlebotomy pathways. Findings will be used to inform future economic evaluations of BloodTrackR.
Sponsors and contacts
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University of Ulster
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator