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.
This study has been co-designed with existing and past users (patients and their carers) of the Heartfelt device who have in the past expressed an interest in sharing their opinion for future research. It is a 6 months crossover randomised controlled trial designed to evaluate the effectiveness of the Heartfelt device, a remote patient monitoring system, in reducing the risk of hospitalisation for heart failure (HF) by monitoring peripheral oedema. We will focus on patients with heart failure who have had at least one hospitalisation for heart failure associated with peripheral oedema in the last year, with stratified randomisation (for the RCT part) to avoid recent discharge effects in the early phases of data collection and focussing on patients considered at high-risk of poor long-term adherence to daily weights (the majority of patients with heart failure). \[8-Fitzgerald\].
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
186
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
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.
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Device used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud.
The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.
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
...and 1 more locations
All-Cause Mortality Rate.
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.
Time frame: Through study completion, an average of 6 months
Device-Related Complication Rate.
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.
Time frame: Through study completion, an average of 6 months
Heart Failure Events Incidence.
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.
Time frame: Through study completion, an average of 6 months
Cause of Death
This records the cause of death classified as related to heart failure (HF) or not, as defined in Abraham WT, 2020 . Measure: Cause of Death Unit of Measure: Date (YYYY-MM-DD)
Time frame: Through study completion, an average of 6 months
Date of Death
This records the date of death classified as related to heart failure (HF) or not, as defined in Abraham WT, 2020 . Measure: Date of Death Unit of Measure: Categorical
Time frame: Through study completion, an average of 6 months
Hospital Admission Duration
Description: This measures the length of hospital stays, noting the admission and discharge dates. Measure: Length of Stay Unit of Measure: Days
Time frame: Through study completion, an average of 6 months
Cause of Hospitalization
This identifies the primary reason for hospitalization. Measure: Cause Hospitalization Category Unit of Measure: Categorical.
Time frame: Through study completion, an average of 6 months
Hospitalisation Admission Route
This identifies the route of admission during hospitalization events, such as ICU, CCU, or ward admission. Measure: Admission Route Unit of Measure: Categorical (ICU, CCU, Ward)
Time frame: Through study completion, an average of 6 months
Loss of Independence
This assesses instances where a patient becomes unable to live at home, necessitating care in a facility. Measure: Change in Living Arrangements Unit of Measure: Binary (Independent, Dependent)
Time frame: Through study completion, an average of 6 months
Scheduling of Care Events
This differentiates between scheduled and unscheduled care events. Measure: Nature of Scheduling Unit of Measure: Categorical (Scheduled, Unscheduled)
Time frame: Through study completion, an average of 6 months
Setting of Care Events
This categorizes care events as either inpatient or outpatient. Measure: Care Setting Unit of Measure: Categorical (Inpatient, Outpatient)
Time frame: Through study completion, an average of 6 months
Date of Changes in HF Medication Post-Discharge
This tracks the date of any change in heart failure medications after the patient returns home, excluding changes made during ward stays. Measure: Medication Adjustment Date Unit of Measure: Date (YYYY-MM-DD)
Time frame: Through study completion, an average of 6 months
Changes in dosage of HF Medication Post-Discharge
This tracks the change(s) in dosage in heart failure medications after the patient returns home, excluding changes made during ward stays. Measure: Medication Adjustment Dosage Unit of Measure: % change from previous dosage.
Time frame: Through study completion, an average of 6 months
Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices
This measures the variance in data availability, encompassing both device-generated and contemporaneous self-reported data. Measure: Degree of Variance Unit of Measure: Number of days per month with physiological measurements taken.
Time frame: Through study completion, an average of 6 months
Timestamp of Health Alerts Generated by the Heartfelt Device
This measures the date and time of health alerts generated by the Heartfelt device. Measure: Timestamp of Health Alerts Unit of Measure: Date and time
Time frame: Through study completion, an average of 6 months
Frequency of Health Alerts Generated by the Heartfelt Device
This measures the number of health alerts generated by the Heartfelt device over a specified period. Measure: Number of Health Alerts Unit of Measure: Count
Time frame: Through study completion, an average of 6 months
Foot volume
This reports the foot volume reported by the Heartfelt device. Measure: Foot and lower leg volume Unit of Measure: mL
Time frame: Through study completion, an average of 6 months
Weight
This measures the patient's weight Measure: patient weight Unit of Measure: Kg
Time frame: Through study completion, an average of 6 months
Peripheral oedema grading
This reports the Peripheral oedema grading reported by the Heartfelt device. Measure: Peripheral oedema grading Heartfelt scale \[0-None / 1-Mild (includes ankle, but no higher) / 2-Moderate (Above the ankle, up to and including the knee)/ 4-Severe (Above the knee)\]
Time frame: Through study completion, an average of 6 months
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