The HEARTFELT Study
Sponsor: Heartfelt Technologies • ClinicalTrials.gov ID: NCT06222099
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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.
Interventions
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Heartfelt Device installed
(Device)
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
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Standard care
(Other)
RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
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Heartfelt-guided care
(Device)
Volume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
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Questionnaires
(Other)
Patients were presented with one or more optional questionnaires (some validated, some bespoke)
Eligibility criteria
Conditions
Locations
- Baptist Health — Little Rock, Arkansas, United States
- HealthArc — Hackensack, New Jersey, United States
- Connect America — Bala-Cynwyd, Pennsylvania, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record