The HEARTFELT Study

Heartfelt Technologies

Status: Begins enrollment in 1 month

Conditions: Heart Failure

Treatments: Device: Direct-to-patient alerts; Other: Questionnaires; Device: Heartfelt Device installed; Other: Standard care; Device: RPMC care

Study type: Interventional

Funder types: Industry

Identifiers

NCT06222099

55241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,500 participants in 4 patient groups

Standard Care (Control)

Active Comparator group

Description:

Device installed at home, capturing data without sending health alerts or measurement data to RPMC.

Treatment:

Other: Standard care

Device: Heartfelt Device installed

Other: Questionnaires

Direct-to-patient health alerts

Experimental group

Description:

Device provides direct health alerts to patients/family, but does not transmit measurement data to RPMC.

Treatment:

Device: Heartfelt Device installed

Other: Questionnaires

Device: Direct-to-patient alerts

RPMC Care Only

Experimental group

Description:

Device transmits measurement data to RPMC without direct patient alerts.

Treatment:

Device: RPMC care

Device: Heartfelt Device installed

Other: Questionnaires

RPMC + Direct-to-Patient Health Alerts

Experimental group

Description:

Device sends measurement data to RPMC and provides direct alerts to patients/family.

Treatment:

Device: RPMC care

Device: Heartfelt Device installed

Device: Direct-to-patient alerts