HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• All-Cause Mortality Rate. — Through study completion, an average of 6 months
  This measure tracks the total number of participant deaths due to any cause during the study period. It is an essential indicator of overall participant survival and general safety of the treatment under investigation. This data is collected and verified through clinical records. Measure: The number of all-cause deaths documented in clinical records. Unit of Measure: Count of deaths.
• Device-Related Complication Rate. — Through study completion, an average of 6 months
  This measure captures the frequency of complications associated with the medical device used in the study. It includes any adverse events or malfunctions linked to the device, providing insight into its safety and performance. Measure: The incidence of complications related to the medical device in use, as specified in Sections 8.1.4 and 8.1.5 of the study protocol. Unit of Measure: Count of complication events.
• Heart Failure Events Incidence. — Through study completion, an average of 6 months
  This metric quantifies the number of times participants have heart failure events. The criteria for what constitutes a heart failure event are based on the definition provided by Abraham WT in 2020, ensuring standardised and specific event classification. Measure: The frequency of hospital events specifically for heart failure, as defined by Abraham WT, 2020. Unit of Measure: Count of heart failure events.

Trial sites (11)

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