The HEARTFELT Study (HEARTFELT)

A Pragmatic, Single-blind, Randomized Crossover Trial Testing the Effectiveness of Autonomous Remote Patient Peripheral Edema Monitoring and Alerting in HEART FailurE Compared to conventionaL remoTe Patient Monitoring.

This study looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the formation of peripheral edema in patients with heart failure (HF).

The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce unscheduled hospitalizations for the management of worsening HF (HFHs).

Patients will be recruited through Remote Patient Monitoring Companies (RPMC) based in the US, using crossover stratified randomization between standard care, Heartfelt device usage with health alerts sent to RPMC and Heartfelt device usage with alerts sent to RPMC as well as on-device alerts in the patient's home.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Heartfelt Device installed; Other: Standard care; Other: Questionnaires; Device: Direct-to-patient alerts; Device: RPMC care

Detailed Description

The hypothesis for this study is that the Heartfelt device can reliably capture foot volume data in patient's home and that this data can be used to monitor patients remotely, ultimately reducing the risk of HF hospitalization.

This is the pivotal trial for the device in the USA.

The study design is a nested crossover randomization between:

• Standard care (control), 162 days: The device is installed in the home and captures data but no health alerts are sent, and the RPMC does not receive measurement data from the device. Measurement data and health alerts are generated and stored for review at the end of the study period to correlate with health issues which occurred during usual care.
• Standard care + Heartfelt (intervention), 162 days: A nested cross of the following interventions
• Direct to patient health alerts, 54 days: The device captures data and alerts are presented to patients/family on the app/SMS/email as well as by voice health alerts on the device. The device does not transmit measurement data or health alerts to the RPMC for review.
• RPMC care only, 54 days: The device captures data and transmits volume measurements and health alerts to the RPMC for review. No direct-to-patient health alerts are generated.
• RPMC + Direct-to-patient health alerts, 54 days: The device captures data and transmits volume measurements and health alerts to the RPMC for review. Health alerts are presented to patients/family on the app/SMS/email as well as by voice health alerts on the device.

Total study length is 366 days (days 0 to 365). There is a 21-day "washout" for days 0-20 and days 183-203. The "washout" period has the device configured to match the period following the "washout". There is no "washout" between each distinct intervention mode.

Date of installation will use stratified random sampling up to 4 months post-consent date for installation month (ensuring at least 3 months since the most recent hospital discharge at the time of screening).

At the completion of both crossover arms, patients will be offered the opportunity to keep the device for as long as the study remains active (potentially up to an additional 4 years, for those patients recruited early in the study). During this long-term follow-up, the device will be placed in "RPMC + Direct-to-patient health alerts" mode (intervention), with randomized 100-day periods where the device is switched into "Standard care" mode (control), not closer than 170 days from the end of one control interval to the beginning of the next.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WH Wilson Tang, MD; Phone Number: +441223 967250; Email: usa.trial@hftech.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form (e-consent via website or app is acceptable)
• Male or female, aged 18 to [No maximum age]…
• Diagnosed with Chronic Heart failure
• Exhibited peripheral edema on at least one HF-related hospitalization in the last 4 years (as documented in EPR).
• Has been hospitalized for HF at least once in the last 12 months.
• Patients who are treated with daily diuretics.
• For females 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.
• Has failed to collect at least 50% of days over the last 180 of physiological data from monitoring devices (80% to 85% of all patients participating), OR has been discontinued from remote patient monitoring due to non-adherence (included in the 80-85%), OR, is considered by clinical team as non-adherent but does not have historical physiological data from monitoring devices (15% to 20% of all patients participating).
• Is enrolled in a Medicare programme.

The RPM company will endeavor to include representative ethnic groups in the recruitment and a minimum of 40% of either biological sex, as well as a mix of ethnicity representative of the local HF patient population.

Exclusion Criteria:

• Participant has bandages to lower limbs every day
• Participant has an amputation of both feet
• Participant is a regular wheelchair user inside their home
• Participant is bed-bound
• Participant is of no fixed abode
• Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
• Participant must not be pregnant and is taking relevant birth control if of child-bearing potential†
• Participant who was unable to have the device installed and activated within 90 days of the randomized installation date.
• Participant is unable to take diuretics

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care (Control); Device installed at home, capturing data without sending health alerts or measurement data to RPMC.	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; Remote patient monitoring companies in regular contact with patients as per their standard operating procedures. (RPMC do not receive measurement data from the Heartfelt device, but will get any other data they collect via their usual methods e.g. remotely monitored weight data); Other Names: Daily weighing, Breathlessness, Dizziness, Tiredness; Other: Questionnaires; Patients were presented with one or more optional questionnaires (some validated, some bespoke); Other Names: KCCQ, 5Q-5D, PAM Questionnaire, Bespoke Questionnaire
Experimental: Direct-to-patient health alerts; Device provides direct health alerts to patients/family, but does not transmit measurement data to RPMC.	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: Questionnaires; Patients were presented with one or more optional questionnaires (some validated, some bespoke); Other Names: KCCQ, 5Q-5D, PAM Questionnaire, Bespoke Questionnaire; Device: Direct-to-patient alerts; The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts).; Other Names: Heartfelt device
Experimental: RPMC Care Only; Device transmits measurement data to RPMC without direct patient alerts.	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: Questionnaires; Patients were presented with one or more optional questionnaires (some validated, some bespoke); Other Names: KCCQ, 5Q-5D, PAM Questionnaire, Bespoke Questionnaire; Device: RPMC care; The RPMC receives measurement data and alert data from the device.; Other Names: Daily weighing, Remote patient monitoring
Experimental: RPMC + Direct-to-Patient Health Alerts; Device sends measurement data to RPMC and provides direct alerts to patients/family.	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; Device: Direct-to-patient alerts; The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts).; Other Names: Heartfelt device; Device: RPMC care; The RPMC receives measurement data and alert data from the device.; Other Names: Daily weighing, Remote patient monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Heart Failure Hospitalization Incidence.	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 hospitalization are based on the definition provided by Hicks KA in 2017, ensuring standardized 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 hospitalization events.	12 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 Section 12.3.3.2 of the study protocol. Unit of Measure: Count of complication events.	12 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	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.	12 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	12 months
Cause of Hospitalization	This identifies the primary reason for hospitalization. Measure: Cause Hospitalization Category Unit of Measure: Categorical.	12 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)	12 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.	12 months
Cause of Death	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: Categorical	12 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)	12 months
Hospitalization 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)	12 months
Scheduling of Care Events	This differentiates between scheduled and unscheduled care events. Measure: Nature of Scheduling Unit of Measure: Categorical (Scheduled, Unscheduled)	12 months
Setting of Care Events	This categorizes care events as either inpatient or outpatient. Measure: Care Setting Unit of Measure: Categorical (Inpatient, Outpatient)	12 months
Study Withdrawal Details	This records the dates and reasons for participants' withdrawal from the study. Measure: Reason for Withdrawal Unit of Measure: Categorical (Various reasons)	12 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	12 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	12 months
Method of Health Alerts Generated by the Heartfelt Device	This assesses the primary methods used to communicate the health alerts generated by the Heartfelt device, categorizing the types of communication employed to notify users. Measure: Type of Communication Method for Health Alerts Unit of Measure: Categorical (e.g., phone call, SMS, email, app notification)	12 months
Timestamp of first contact following Health Alerts Generated by the Heartfelt Device	Description: This measures the date and time of the first contact following health alerts generated by the Heartfelt device. Measure: Timestamp of first contact in the 2 weeks following a Health Alerts Unit of Measure: Date and time	12 months
Method of Contact Following Health Alerts	This measures the type of contact method initiated in response to health alerts from the Heartfelt device, detailing the types of follow-up communications. Measure: Type of Communication Method for Contact Unit of Measure: Categorical (e.g., phone call, SMS, email, in-person visit)	12 months

Collaborators and Investigators

• Sponsor: Heartfelt Technologies
• Investigators: Study Chair: WH Wilson Tang, MD, Cleveland Clinic, USA

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 55241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data collected for this study will be analyzed and stored by the Sponsor. After the study is completed, the de-identified, archived data will be transmitted to and stored by the Sponsor, for use by other researchers including those outside of the study. Permission to transmit data to the Sponsor will be included in the informed consent.

To further reduce the risk of patient identification, we will not associate patient with a named RPMC, we will instead use a site ID for each RPMC.

During the conduct of the study, an individual participant can choose to withdraw consent to have their de-identified data stored for future research. However, withdrawal of consent with regard to data storage may not be possible after the study is completed.

When the study is completed, access to study de-identified data will be provided through the Sponsor.

• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Contact the Sponsor
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes