Heart Failure Clinical Trial
Remote Monitoring of Multiple Indicators of Heart Failure
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Outpatients cared for by BJH Advanced Heart Failure Clinic, where BJH is their primary cardiology care team
Age ≥ 18 years old at time of consent
HFrEF diagnosis in the BJH Advanced Heart Failure Clinic medical record
Has had an ER presentation or hospitalization related to their heart failure in last 12 months prior to enrollment
Most recent recorded Left Ventricular Ejection Fraction (LVEF) of < 50% and at least 1 recorded LVEF of < 40%
Scheduled clinic visit 90- 180 days after study enrollment.
NYHA Class II-IV
Sleeps in the same bed at ≥ 4 days per week
Able to ambulate
Willingness to complete the required surveys, measurements and study activities
Exclusion Criteria:
Current ventricular assist device or cardiac transplant.
Currently listed for cardiac transplantation
End-Stage Renal Disease on chronic dialysis
Malignancy diagnosis undergoing active treatment
Hospice or palliative care
Living in a skilled nursing facility or other chronic care facility (ambulatory patients only)
Self-reported pregnancy or planned pregnancy in the next 6 months
Inability or unwillingness to consent and/or follow requirements of the study
Planned major surgeries or procedures requiring hospitalization in next 6 months
Use of Lifevest or other worn device that may affect ballistocardiogram measurements
Patient weight > 385 lbs at time of enrollment
Life expectancy <1 year
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There is 1 Location for this study
Saint Louis Missouri, 63110, United States
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