Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK. (HF-TRACK)

March 21, 2024 updated by: Heartfelt Technologies

Randomised Controlled Trial For Assessing The Effectiveness Of An Inclusive Heart Failure Monitoring And Tracking Solution In The UK.(HF-TRACK)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • East Riding Of Yorkshire
      • Hull, East Riding Of Yorkshire, United Kingdom, HU7 5DD
        • Dr R Raut & Partnership (General Practice)
        • Contact:
        • Principal Investigator:
          • Rajeev Raut, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

In order to be eligible to participate in this trial, an individual must meet all of the following criteria:

Provision of signed and dated informed consent form (e-consent via website or app is acceptable).

Women or men, aged 18 years or older [No maximum age]. Diagnosis of heart failure at least 3 months previously Receiving diuretics on a daily basis Peripheral oedema reported on at least one HF-related hospitalisation in the last 4 years (as documented in EPR).

Hospitalised for HF OR has received IV diuretic treatment in the last 12 months.

For women of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study.

Is considered by the investigator to be non-adherent OR at high risk of HF hospital readmissions.

In addition, at least 10 patients with a CardioMEMS, Heartlogic device or other implanted device capable of making physiological measurements designed to prevent admission for heart failure.

In line with the NIHR INCLUDE guidance27 , the study team will endeavour to include patients representative of the patients with heart failure in the UK, including, but not restricted to, ethnic minorities and a similar number of women and men.

Patients with or without a reduced left ventricular ejection fraction can be enrolled.

Patients who are unable to give consent due to impaired capacity can still participate in the study, provided that either a Personal Consultee or a Nominated Consultee is engaged in accordance with the Mental Capacity Act 2005 (MCA). Additionally, it is required that the researcher responsible for enrolling these patients has received training on how to obtain consent in such circumstances.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

bandages to lower limbs every day amputation of both feet regular wheelchair user inside their home bed-bound no fixed abode taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes Pregnancy or lack of contraceptive measures if of child-bearing potential† Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study.

Patients with severe aortic stenosis or awaiting a heart procedure or surgery

† This exclusion criterion has been requested by the insurance provider for clinical trial cover.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Care + Heartfelt device
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, the device sends alerts and measurement data to the patient, carers and clinicians.
Device: Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Other Names:
  • Remote patient monitoring device
Other: 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.
Other Names:
  • Daily weighing, Breathlessness, Dizziness, Tiredness
Other: Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Other Names:
  • 5Q-5D, Bespoke Questionnaires
Device: Heartfelt device alerting system
The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and medical professionals.
Other Names:
  • Remote patient monitoring device
Active Comparator: Standard care (control)
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians.
Device: Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Other Names:
  • Remote patient monitoring device
Other: 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.
Other Names:
  • Daily weighing, Breathlessness, Dizziness, Tiredness
Other: Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Other Names:
  • 5Q-5D, Bespoke Questionnaires
Experimental: Standard Care + Heartfelt device in pharmacy
Participants will follow standard care advice, and have monthly measurements taken at the pharmacy using the Heartfelt device. The pharmacist will receive the measurements and alerts and be able to communicate this to the participant.
Other: 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.
Other Names:
  • Daily weighing, Breathlessness, Dizziness, Tiredness
Other: Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Other Names:
  • 5Q-5D, Bespoke Questionnaires
Device: 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.
Other Names:
  • Monitoring device used in phamarcy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality Rate.
Time Frame: 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.
6 months
Heart Failure Hospitalisation Incidence.
Time Frame: 6 months

This metric quantifies the number of times participants are admitted to the hospital due to heart failure. The criteria for what constitutes a heart failure hospitalisation are based on the definition provided by Hicks KA in 2017, ensuring standardised and specific event classification.

Measure: The frequency of hospital admissions specifically for heart failure, as defined by Hicks KA, 2017.

Unit of Measure: Count of heart failure hospitalisation events.
6 months
Device-Related Complication Rate.
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices
Time Frame: 6 months

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.
6 months
Hospital Admission Duration
Time Frame: 6 months

Description:

This measures the length of hospital stays, noting the admission and discharge dates.

Measure: Length of Stay Unit of Measure: Days
6 months
Cause of Hospitalization
Time Frame: 6 months
This identifies the primary reason for hospitalization. Measure: Cause Hospitalization Category Unit of Measure: Categorical.
6 months
Date of Changes in HF Medication Post-Discharge
Time Frame: 6 months

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)
6 months
Changes in dosage of HF Medication Post-Discharge
Time Frame: 6 months

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.
6 months
Cause of Death
Time Frame: 6 months

This records the cause of death classified as related to heart failure (HF) or not, as defined in Hicks KA, 2017.

Measure: Cause of Death Unit of Measure: Date (YYYY-MM-DD)
6 months
Date of Death
Time Frame: 6 months

This records the date of death classified as related to heart failure (HF) or not, as defined in Hicks KA, 2017.

Measure: Date of Death Unit of Measure: Categorical
6 months
Loss of Independence
Time Frame: 6 months

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)
6 months
Hospitalisation Admission Route
Time Frame: 6 months

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)
6 months
Scheduling of Care Events
Time Frame: 6 months
This differentiates between scheduled and unscheduled care events. Measure: Nature of Scheduling Unit of Measure: Categorical (Scheduled, Unscheduled)
6 months
Setting of Care Events
Time Frame: 6 months
This categorizes care events as either inpatient or outpatient. Measure: Care Setting Unit of Measure: Categorical (Inpatient, Outpatient)
6 months
Timestamp of Health Alerts Generated by the Heartfelt Device
Time Frame: 6 months

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
6 months
Frequency of Health Alerts Generated by the Heartfelt Device
Time Frame: 6 months

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
6 months
Foot volume
Time Frame: 6 months
This reports the foot volume reported by the Heartfelt device. Measure: Foot and lower leg volume Unit of Measure: mL
6 months
Peripheral oedema grading
Time Frame: Unit of Measure: 1-4 scale
This reports the Peripheral oedema grading reported by the Heartfelt device. Measure: Peripheral oedema grading Heartfelt scale
Unit of Measure: 1-4 scale
Weight
Time Frame: 6 months
This measures the patient's weight Measure: patient weight Unit of Measure: Kg
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heartfelt Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFT-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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