protocolSection identificationModule nctId: NCT06334822, orgStudyIdInfo id: HFT-2024-01, briefTitle: Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK., acronym: HF-TRACK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Heartfelt Technologies, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This 6-month study involves up to 210 patients using the Heartfelt device at home. It is a crossover trial with a 21-day break between two 69-day periods to prevent overlap effects. Patients will either receive standard care or standard care plus Heartfelt alerts. The Heartfelt group is further divided into three 23-day sub-studies to test different alert systems.Another 60 patients will have monthly measurements taken at the pharmacy without being part of the main randomisation., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Only outcomes assessors will be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Heartfelt Device installed, interventions name: Standard care, interventions name: Questionnaires, interventions name: Heartfelt Device in pharmacy, interventions name: Heartfelt device alerting system, outcomesModule primaryOutcomes measure: All-Cause Mortality Rate., primaryOutcomes measure: Heart Failure Hospitalisation Incidence., primaryOutcomes measure: Device-Related Complication Rate., secondaryOutcomes measure: Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices, secondaryOutcomes measure: Hospital Admission Duration, secondaryOutcomes measure: Cause of Hospitalization, secondaryOutcomes measure: Date of Changes in HF Medication Post-Discharge, secondaryOutcomes measure: Changes in dosage of HF Medication Post-Discharge, secondaryOutcomes measure: Cause of Death, secondaryOutcomes measure: Date of Death, secondaryOutcomes measure: Loss of Independence, secondaryOutcomes measure: Hospitalisation Admission Route, secondaryOutcomes measure: Scheduling of Care Events, secondaryOutcomes measure: Setting of Care Events, secondaryOutcomes measure: Timestamp of Health Alerts Generated by the Heartfelt Device, secondaryOutcomes measure: Frequency of Health Alerts Generated by the Heartfelt Device, secondaryOutcomes measure: Foot volume, secondaryOutcomes measure: Peripheral oedema grading, secondaryOutcomes measure: Weight, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr R Raut & Partnership (General Practice), city: Hull, state: East Riding Of Yorkshire, zip: HU7 5DD, country: United Kingdom, contacts name: Rajeev Raut, MD, role: CONTACT, phone: +441482 835880, email: HF-TRACK@hftech.org, contacts name: Rajeev Raut, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.7446, lon: -0.33525, hasResults: False