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Clinical Trials/NCT07660029
NCT07660029RecruitingNot Applicable

BloodTrackR Usability and Concordance Study (BUCS)

University of Ulster1 site in 1 country20 target enrollmentStarted: June 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1

Study Overview

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.

Detailed Description

Background:

Blood testing is one of the most important tools in healthcare, but the way samples are collected and processed today creates barriers for both patients and the NHS. Most blood tests require a hospital or GP visit for venous blood draw. This can be inconvenient and stressful for patients, particularly those with long-term conditions who need frequent monitoring, and it places additional demand on already stretched NHS staff. In clinical trials, reliance on centralised sample collection and processing slows recruitment and increases costs. Current alternatives, such as dried blood spot (DBS) sampling, have limitations in accuracy due to the "haematocrit effect," which reduces trust in results.

The impact is significant: patients face delays and additional travel, NHS services struggle with capacity, and healthcare costs increase. There is an urgent need for simple, reliable solutions that support blood testing in the community, reduce workforce pressure, and improve patient experience.

BloodTrackR, is a novel blood collection device and companion mobile app developed by the researchers that allows people collect their own blood samples at home. A key focus of BloodTrackR is the measurement of inflammation in rheumatoid arthritis, which is not visible to clinicians outside clinic visits, so that treatment can be adjusted in real time rather than at the next scheduled appointment. This helps identify early signs of disease flares and ensures disease activity is kept under control. Given that chronic inflammatory conditions are frequently associated with multi-morbidity, BloodTrackR could also provide a platform for monitoring co-occurring conditions, such as diabetes or cardiovascular disease, from the same device. This creates opportunities to consolidate patient monitoring, reduce missed opportunities for treatment adjustment, and ensure therapy is as effective as possible across multiple conditions.

This reusable device incorporates a proprietary plasma separation process that produces dried plasma samples, rather than dried blood spots, overcoming limitations of the haematocrit effect. Built-in sample stabilisation, temperature monitoring, and precise time-stamping safeguard sample quality and integrity during transport and storage. The companion mobile app links samples with patient-reported symptoms and medications, creating rich longitudinal datasets that can inform clinical decision-making, support remote monitoring, and trigger earlier intervention.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: BloodTrackR - Home Blood Collection Platform (Device)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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