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HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device
Sponsor: Heartfelt Technologies
Summary
The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization. Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly. The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy. This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges.
Official title: Randomised Controlled Trial For Assessing The Effectiveness Of An Inclusive Heart Failure Monitoring And Tracking Solution In The UK.(HF-TRACK)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
186
Start Date
2024-07-11
Completion Date
2027-01-31
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Standard care
Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. They should also report changes in breathlessness, tiredness and other symptoms associated with heart failure decompensation.
Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt Device in pharmacy
Device used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud.
Heartfelt device alerting system
The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.
Locations (11)
The Ridings Medical Group
Brough, East Riding Of Yorkshire, United Kingdom
Dr R Raut & Partnership (General Practice)
Hull, East Riding Of Yorkshire, United Kingdom
Croydon Health Services NHS Trust
Croydon, London, United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds, Suffolk, United Kingdom
Modality East Surrey Medical Practice
Horley, Surrey, United Kingdom
Modality Partnership Airedale, Wharfedale & Craven:
Keighley, West Yorkshire, United Kingdom
Pillsorted Ltd
Cambridge, United Kingdom
DR GT Hendow Surgery
Hull, United Kingdom
Sutton Manor Pharma Services
Hull, United Kingdom
James Alexander Family Practice
Hull, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
London, United Kingdom