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Clinical Trial Summary

This study is intended to evaluate the impact of passive continuous remote patient monitoring to assist in the outpatient management of heart failure (HF) patients.


Clinical Trial Description

The study will prospectively evaluate the usability, utility, and efficacy of remote monitoring using novel noninvasive technologies in HF patients in an outpatient setting. Investigators will gather dynamic, longitudinal data from multiple sensors, in addition to patient-reported and physician-reported data. Both the patient interface through interactions with the sensors and mobile application, and the clinician interface through the monitoring portal, will be evaluated for usability, utility and efficacy. Patients will be recruited for the study from the Barnes Jewish Hospital Advanced Heart Failure Clinic. Eligible individuals will receive onboarding instructions and a study schedule detailing the required surveys and clinical activities they will be asked to complete over a period of 7 months. In addition to onboarding instructions and a study schedule, individuals will have the kit of sensors shipped to their home. After the Myia Home Hub and Myia Sensor Suite are set up, data will begin to be transmitted. Following a run in period where data is collected and delivered but not acted upon by clinicians all eligible participants will move forward with 6 month interactive study monitoring. In addition to obtaining questionnaires and using the devices in the Myia kit, participants will also be asked to obtain their blood pressure and weight daily. During the course of the study, outpatient health status data for the group will be collected, summarized and delivered to clinicians in an electronic dashboard. The format and content of the data dashboard will be updated based on user feedback throughout the study. Required changes deemed appropriate by the healthcare team will be incorporated into the software platform alongside any standard updates. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04267744
Study type Interventional
Source Washington University School of Medicine
Contact
Status Active, not recruiting
Phase N/A
Start date February 11, 2020
Completion date August 1, 2024

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