Effectiveness and health economics study of a foot-volume-measuring device using 3D imagery and AI to automatically monitor heart failure patients and prevent hospitalisations.

Research Question: Does implementation of the Heartfelt device among patients with chronic HF lead to substantial reductions in hospitalisations and improvement in quality of life and, if so, is it cost-effective? Background: In the UK alone, HF causes or contributes to about 400K hospital admissions each year. Poor adherence to advice on self-monitoring of weight and to prescribed therapy are key factors contributing to worsening symptoms and hospital readmissions. The Heartfelt device, co-developed with HF patients with HF and their families, offers a monitoring solution even for those patients with HF with poor adherence to advice, autonomously capturing physiological measurements to facilitate optimisation of therapy, enhance education and adherence to treatment and hence reduce hospitalisations. Preliminary data are encouraging. Efficacy, safety, and cost-effectiveness of the Heartfelt device now require confirmation in a substantial trial. Aims and Objectives: Evaluate the effect of the HeartFelt device on morbidity, mortality and quality of life. Health economic assessment of using the Heartfelt device, compared to standard care. Assess user acceptability and implementation challenges, through qualitative interviews with patients, carers and clinicians. Foster efficient collaborations with early adopter sites, Health Innovation Networks, and potential partners, ensuring dissemination of our findings and their wide-scale adoption. Methods: The project team brings together patients, academics, clinicians, clinical trial units (CTU), advisors and a Med Tech start up to deliver a multi-disciplinary project. The project comprises six work packages (WP) centred around a randomised controlled trial (RCT) designed to enrol 300 patients with HF across 15 sites in the UK. Key activities include analysis of patient centred outcomes (eg. hospitalisation and quality of life), as well as detailed health economics analysis, process evaluation, results disseminations. The RCT will focus on patients at high risk of HF-hospitalisations. In the intervention arm, the Heartfelt device will raise alerts autonomously even if the patient does not adhere to recommended self-checks. Conversely, in the control arm, the device will collect data but not raise alerts, avoiding interference with standard care and enabling sensitivity/specificity to be calculated using control arm measurements. Qualitative research will identify barriers and enablers for adoption as well as the creation of an implementation guide to support the adoption of the technology. A thorough health economic assessment will be conducted, comparing the device's cost-effectiveness to established clinical practice and other monitoring devices. Anticipated Impact and Dissemination: We will share our findings via scientific articles, conferences, and collaborations with healthcare professionals, institutions and policymakers. For the general public, we will work with our PPIE representatives to create informative videos and brochures, we will facilitate community workshops and outreach through media, these will also be provided in different languages when possible. Key milestones (see Gannt chart) include: Recruitment of 25 patients per month between months 7-18 All devices installed by month 18 Data collected by month 30 Final analysis, health economics report, process evaluation completed by month 36 Submission for NICE Medical Technologies Evaluation Programme by month 33 Dissemination activities will happen in two bursts between months 17-19 and then 32-36