BloodTrackR Usability and Concordance Study (BUCS): Evaluating a Smart Home-Based Blood Collection Platform for Remote Monitoring in Rheumatoid Arthritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Ulster

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • BloodTrackR - Home Blood Collection Platform

    Device

    A home-based blood collection device and mobile application that enables remote blood sampling, symptom tracking, temperature monitoring, and sample traceability.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Adults with Rheumatoid Arthritis1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately after completion of BloodTrackR device use (same day)

Secondary outcomes

1

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.

Time frame
Following completion of device use (up to 1 month)
2

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.

Time frame
1 week following device use
3

Successful Home Blood Sample Collection Rate

Proportion of participants able to successfully collect and return a blood sample using the BloodTrackR device without assistance.

Time frame
Up to 1 day following device use
4

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.

Time frame
At completion of study participation (up to 3 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ulster

Lead sponsor

National Institute for Health Research, United Kingdom

Collaborator