This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development 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 hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives: 1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes. Participants will need to: * Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.
Participants will be recruited through Remote Patient Monitoring Providers (RPMPs) based in the US, using crossover randomization between standard care and Heartfelt device usage with health alerts sent to RPMPs. The RPMPs will follow a protocolized intervention when responding to raised alerts. The study design is a 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 RPMP does not receive data from the device. (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: The device captures data and transmits volume measurements and health alerts to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient. At consent, patients get randomized to an install date over a period from 21 to 60 days following consent, subject to scheduling this at least 14 days after the most recent recorded hospital discharge at the time of consent, or the discharge from their current hospitalization if hospitalized at the time of consent. Total study length is 366 days (days 0 to 365). There are two 21-day "washout" periods to prevent carryover between study arms. The first washout period extends from day 0-20 inclusive, and the second from day 183-203 inclusive 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 "Intervention" mode, with randomized 100-day periods where the device is switched into "Standard care" mode (control).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,500
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
Volume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
Patients were presented with one or more optional questionnaires (some validated, some bespoke)
Baptist Health
Little Rock, Arkansas, United States
ACTIVE_NOT_RECRUITINGHealthArc
Hackensack, New Jersey, United States
RECRUITINGConnect America
Bala-Cynwyd, Pennsylvania, United States
RECRUITINGHeart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])
Used to demonstrate whether the device effectively reduces HFHs and urgent HF visits.
Time frame: 12 months, plus up to 48 months long term follow-up
Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL
Used to ensure that increased diuretic treatment following alerts from the device does not lead to significant increase in AKI
Time frame: 12 months, plus up to 48 months long term follow-up
Difference in data availability (device generated or contemporaneous self-report)
Used to measure the data availability from the Heartfelt device. One of the key findings from feasibility trials and pilot studies in the UK have demonstrated an increased data availability. Does this study in the US confirm the previous finding?
Time frame: 12 months, plus up to 48 months long term follow-up
The date and length (in hours) of hospital admission and re-admissions
Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.
Time frame: 12 months, plus up to 48 months long term follow-up
Cause of hospitalizations (HF or non-HF)
Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.
Time frame: 12 months, plus up to 48 months long term follow-up
Date of increase in HF medications when the patient is home or in the community (not the detailed changes whilst on the ward)
This may include oral diuretic, IV diuretics and subcutaneous furosemide injections. Used to allow the determination if an outpatient appointment is HF related or not.
Time frame: 12 months, plus up to 48 months long term follow-up
Death and cause of death from the clinical record (HF or non-HF as defined in [1-Abraham])
Used to establish if using the device changes HF- or non-HF mortality.
Time frame: 12 months, plus up to 48 months long term follow-up
Loss of independence (patient unable to live at home; for example, relocation to a care facility for an indefinite duration)
Used to establish if there has been an effect on the ability of the patient to live independently in their home.
Time frame: 12 months, plus up to 48 months long term follow-up
Route of admission for hospitalization events (ICU, CCU, or ward admission),and discharge (home, skilled nursing facility and long term care facility).
Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.
Time frame: 12 months, plus up to 48 months long term follow-up
Scheduling of care events (scheduled or unscheduled)
Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.
Time frame: 12 months, plus up to 48 months long term follow-up
The setting of care events (inpatient or outpatient)
Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.
Time frame: 12 months, plus up to 48 months long term follow-up
Date and time of health alerts generated by the Heartfelt device
Used to establish the response time to health alerts.
Time frame: 12 months, plus up to 48 months long term follow-up
Date, time and method of contact made following reception of a health alert generated by the Heartfelt device
Used to establish the response time to health alerts.
Time frame: 12 months, plus up to 48 months long term follow-up
Date and reason for study withdrawal
Used alongside the analysis of other right-censoring endpoints.
Time frame: 12 months, plus up to 48 months long term follow-up
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