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

NCT07660029 | Recruiting

• 2 other identifiers: REC/26/0021NIHR510810
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA); Remote Patient Monitoring

Keywords

Rheumatoid Arthritis; Home Blood Collection; Remote Patient Monitoring; BloodTrackR; Blood Microsampling; CRP; Usability Study; Concordance Study; Digital Health; Mobile Health; Remote Monitoring

Outcome Measures

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.

  Immediately after completion of BloodTrackR device use (same day)

Secondary Outcomes (6)

• Post-Procedure Semi-Structured Interview on BloodTrackR User Experience

  Following completion of device use (up to 1 month)

• Concordance Between BloodTrackR device and Venous CRP Measurements

  1 week following device use

• Successful Home Blood Sample Collection Rate

  Up to 1 day following device use

• Estimated Patient Time Associated With Blood Collection

  At completion of study participation (up to 3 months)

• Estimated Healthcare Staff Workload Associated With Blood Collection

  At completion of study participation (up to 3 months)

Study Arms (1)

Adults with Rheumatoid Arthritis

Adults aged 18 years and older with rheumatoid arthritis who will use the BloodTrackR home blood collection device and companion mobile application. Participants will collect a blood sample at home and undergo paired venous blood sampling for concordance testing. Usability, acceptability, and user experience will be assessed through questionnaires and interviews.

Device: BloodTrackR - Home Blood Collection Platform

Interventions

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.

Adults with Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Access to WiFi and a smartphone/tablet

You may not qualify if:

• Participants \<18years
• Participants taking antibiotics/antivirals
• No access to WiFi or a smartphone/tablet

Sponsors & Collaborators

• University of Ulster: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Personalised Medicine Centre

Londonderry, BT47 6SB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected using the BloodTrackR device and paired venous blood samples collected by a qualified phlebotomist. Samples will be used for C-reactive protein (CRP) analysis and concordance testing between capillary and venous blood collection methods. No genetic or DNA analysis will be performed.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Gibson

  Ulster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jency Rajan

CONTACT

00447486455613; j.rajan@ulster.ac.uk

David Gibson

CONTACT

+442871675663; d.gibson@ulster.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

GB (1)