Recipient organisationUniversity Hospitals of North Midlands NHS TrustSource-published name: University Hospitals of North Midlands NHS Trust
Funding£1.3M
PeriodJul 2015 — Jun 2018
In plain English
AI plain-English summary
A portable device will use a saliva sample to detect early signs of a COPD flare-up, sending results directly to a patient’s smartphone and their clinician. COPD exacerbations—sudden worsening of symptoms—are a leading cause of hospital admissions and can be life-threatening. Current monitoring relies on subjective symptom diaries or infrequent clinic visits, which often miss the early window for treatment. This project aims to build a point-of-care biosensor that measures three inflammatory biomarkers (CRP, PCT, and NE) in saliva, combined with a patient wellbeing app that includes gamified education and a triage algorithm to predict episodes. If successful, the COPD-SPOC monitor could shift COPD management from reactive hospital care to proactive home monitoring. Patients would catch exacerbations earlier, potentially reducing emergency admissions and improving quality of life. The device is designed for community-based use, with a 30-patient, six-month feasibility study planned to test its accuracy and user experience. The project also includes a health economic analysis to assess cost-effectiveness for the NHS.
View original technical description
Over a 36-month (M) period, 20 clearly defined work packages (WP) [Gantt chart] will be undertaken to deliver 6 objectives: Objective 1: A dedicated expert by experience forum, including 6 COPD patients, will actively buddy the researchers in an iterative process throughout design, development and refinement of the saliva sampler, monitor and interactive platform [M1-30]; linking into particular work packages e.g. WP5, 6, 7, 9 and 11. Input will involve a series of steps e.g. sketch displays/prototypes. Healthcare professionals/providers will also be engaged for scoping the monitor s position within the COPD care pathway. Objective 2: The fully functional COPD-SPOC monitor incorporates: A magnetometer system to quantify binding of magnetic particles to the sensor surface for 3 target biomarkers. An assay reaction vessel/consumable containing the chemical components to measure salivary levels of CRP, PCT and NE. This docks into magnetometer system for measurement. A saliva collector, also transferring sample to reaction vessel. In collaboration with specialised subcontractors with proven track-record in biomedical-diagnostic instrumentation, the activities for developing each component will include: 2.1. Advanced magnetometer development [M1-21] Design and manufacture early prototype 3 coil magnetometer Refine design through laboratory/end-user testing Manufacture refined prototypes Develop Graphical User Interface Signal processing to extract biomarker levels. 2.2. Assay reaction vessel (consumable) development [M1-15] Design and manufacture early prototype consumable Analytical and end-user evaluation Manufacture refined prototype 2.3. Design optimisation and suitability of saliva collection device [M1-15] Design and manufacture early prototype saliva collector End-user evaluation and laboratory testing Manufacture refined prototype 2.4. Assay integration for three salivary biomarkers [M1–15] Develop protocols to produce paramagnetic particles and surfaces in the consumable with controllable antibody activity Optimise stability of antibody coated sensor surface and particles Adapt assay protocols for microfluidic processes and surfaces in the consumable 2.5. Integration, testing and refinement of complete COPD-SPOC monitor system [M16-35] Demonstrate microfluidic functional compatibility of COPD-SPOC monitor system Demonstrate working assays for the three biomarkers and use on saliva samples with defined concentrations Final Improvements to COPD-SPOC system 2.6. Establishing processes for regulatory approval [M1-M35] Establish regulatory compliant procedures Collection of technical file/user requirements documentation. Objective 3: Effective and engaging intervention in patient self-monitoring will involve: 3.1. Further developing the patient wellbeing diary App [Figs.7, 8] to include patient-clinician bi-directional communication and simple gamification to motivate and educate patients on early exacerbation recognition/treatment compliance [M1-M18]. 3.2. Designing and constructing software for prediction/triage of COPD episodes, based on combining saliva biomarker measurements and patient wellbeing scores [M13-M24]. Objective 4: The complete COPD-SPOC monitor prototype will be evaluated in a community-based study involving 30 COPD patients for 6 months [M25-33]. This will also evaluate the App and the saliva collector. Prototype-measured analyte levels will be compared with results from commercially available kits. Semi-structured qualitative interviews will explore individual patients real experiences; data will enhance quantitative measures of patient utilisation of the system by providing information about patients day-to-day lived experience of monitoring their COPD, together with the reasons for engagement/behaviour. Objective 5: The health economic case and business model will be strengthened by: Incorporating
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