HF-TRACK
Research type
Research Study
Full title
Randomised controlled trial for assessing the effectiveness of an inclusive Heart Failure monitoring and TRACKing solution in the UK.
IRAS ID
343630
Contact name
o Chausiaux
Contact email
Sponsor organisation
Heartfelt Technologies Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
This study looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the formation of peripheral oedema in patients with heart failure (HF). The hypothesis is that this passive measurement method will improve patient care and reduce unscheduled hospitalisations for the management of worsening HF (HFHs) through better data availability.
Patients will be recruited through Hospital settings or community settings (GP, community nurses and pharmacies) based in the UK, using crossover randomisation between standard care and heartfelt device usage with health alerts.
Patients’ outcomes will also be compared to control patients who are not enrolled in the study to check for any bias in recruitment in the study, if this data can be made available.
As a separate sub-study, some participants will not have the device installed at home, but will have measurements taken in the high street pharmacies in an opportunistic manner (when they go to collect their medication supplies for example). [“in-pharmacy measurement only” group]
A detailed schematic describing all visits and a schedule of assessments is included in the Schema and Schedule of Activities, Appendices A and B, respectively.
As part of our commitment to patient engagement within the trial, participants will be actively involved in shaping the study's outcomes through a structured feedback process which will play a crucial role in determining the significance of various outcomes. For instance, based on participant feedback, the study may prioritise the impact of a single hospitalisation lasting five days over the necessity of multiple visits to a General Practitioner (GP). This approach not only ensures that our research reflects the real-world priorities of patients but also enhances the relevance of our findings to patient care.
Moreover, to ensure that the perspectives and priorities of patients are accurately reflected in our scholarly outputs, Patient and Public Involvement (PPI) representatives will be integral to the process of drafting publications.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0164
Date of REC Opinion
11 Jul 2024
REC opinion
Further Information Favourable Opinion