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

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. This research will evaluate BloodTrackR, a novel blood collection device and companion App designed for use at home or in community settings and in addition, to ascertain: 1. If the participants can reliably use BloodTrackR to collect and stabilise high-quality blood plasma samples outside of a hospital setting 2. Will this approach reduce the burden on NHS services? Aim: This study aims to evaluate the reliability, usability, and acceptability of BloodTrackR-a novel at-home blood/collection device and companion mobile app-to determine its capacity to reduce reliance on NHS phlebotomy services and identify measurable outcomes that indicate its potential to alleviate NHS workforce burden. Objectives: * To Assess usability and patient acceptability of the device and app in real-world settings. * Evaluate the quality and stability of samples collected and transported from home. * Gather feedback from PPI workshops to inform device refinement and adoption. * Generate evidence to demonstrate potential workforce and system benefits for the NHS. Study Design: The current research is a usability mixed method study and will be conducted in 3 phases: Methodology: Recruitment: Participants n=20 will be recruited via Rheumatoid Arthritis support groups and their charity partners via the group leaders for which our centre has extensive experience working with and who have already provided feedback on early device design. In addition, participants who have previously taken part in research studies under the CI and have provided enduring consent will also be sent information on the study. The researcher employed onto the study will arrange to attend the group(s) to give an informal talk about the research and leave Participant information sheets (PIS) for those interested and to answer any questions. If after reading the PIS and the participant is happy to proceed, they will be asked to contact the researcher via the contact details provided on the PIS to check their eligibility via a screening questionnaire. If eligible, the researcher will then gain informed consent either by post or in person prior to participants being enrolled onto the study. Phase 1: Usability and acceptability: Those participants who have consented to participate in the study will be advised that they will receive their BloodTrackR device by post in a pack complete with instructions. This will be supplemented by remote training on the correct use of the BloodTrackR device and companion app, delivered via Microsoft Teams, to support participants in collecting their own capillary blood sample at home and simultaneously log their assessment of disease activity via the Clinical Disease Activity Index (CDAI) and the Routine Assessment of Patient Index data 3 (RAPID 3) assessment questionnaires which measure the participants physical function, symptoms, pain, and overall global health all via the app. The logged data is accessible only to the named researcher(s) and is de-identified. Usability and compliance will be assessed via a structured questionnaire which will be posted out along with the device to complete when the participant has completed the procedure. In addition, the data usage logged by the App will be collected. This feedback will provide rich insight into user experience, barriers to adoption and opportunities for refinement. Phase 2: Concordance Study Patient-collected capillary device samples collected via the BloodTrackR device will be validated against matched venous blood draws which will be collected around the same time as they self-collect their device based capillary sample. The participant will be asked to return the device with the sample contained in the well to the Personalised Medicine Centre;PMC in the addressed, prepaid envelope provided. The 6ml venous serum sample will be collected by a qualified phlebotomist to confirm quality and integrity against the device-based samples. The qualified phlebotomist will attend the participant's home solely for the purpose of collecting the venous blood sample. They are not a member of the research team and will have no role in, or influence over, the participant's self-collection of the capillary blood sample using the study device and accompanying app. The phlebotomist's involvement is limited to venepuncture procedures. C-reactive protein (CRP) concentration will be compared between the two sample types using ELISA assays at PMC from the device sample and gold standard hospital laboratory analysis (Altnagelvin hospital, Western Health and Social Care Trust). This will confirm whether CRP values from home-collected plasma samples via the device are equivalent to standard of care phlebotomy, in terms of sample quality and clinical reliability of CRP levels detected. In addition, participants will be asked post procedure to participate in a one-to-one interview either via Teams, telephone or face to face (either in their own home or in C-TRIC). Interviews will be digitally recorded (following informed consent), transcribed verbatim and analysed following the template analysis style outlined by Miles and Huberman (1994). Phase 3: Health Economic Analysis We will conduct an initial health economic assessment of BloodTrackR relative to current NHS phlebotomy practice. Metrics will include time saved per patient (reduced travel, waiting, and clinic time), reduction in staff workload compared with current phlebotomy practice, and early cost modelling (device/test vs \~£50 per current phlebotomy episode). These analyses will provide early evidence of workforce and system-level benefits.