Clinical trial NCT04267744: Remote Monitoring of Multiple Indicators of Heart Failure
Official title: Usability and Utility Assessment of Passive Remote Monitoring of Multiple Novel Indicators of Heart Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: NYHA II-IV
Reduced Ejection Fraction
Cardiology
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Healthcare Innovation Lab
name: MYIA Labs, Inc.
First posted: 2020-02-13
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device: Myia Health platform and in-home suite of devices®
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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:

1. Outpatients cared for by BJH Advanced Heart Failure Clinic, where BJH is their primary cardiology care team
2. Age ≥ 18 years old at time of consent
3. HFrEF diagnosis in the BJH Advanced Heart Failure Clinic medical record
4. Has had an ER presentation or hospitalization related to their heart failure in last 12 months prior to enrollment
5. Most recent recorded Left Ventricular Ejection Fraction (LVEF) of \< 50% and at least 1 recorded LVEF of \< 40%
6. Scheduled clinic visit 90- 180 days after study enrollment.
7. NYHA Class II-IV
8. Sleeps in the same bed at ≥ 4 days per week
9. Able to ambulate
10. Willingness to complete the required surveys, measurements and study activities

Exclusion Criteria:

1. Current ventricular assist device or cardiac transplant.
2. Currently listed for cardiac transplantation
3. End-Stage Renal Disease on chronic dialysis
4. Malignancy diagnosis undergoing active treatment
5. Hospice or palliative care
6. Living in a skilled nursing facility or other chronic care facility (ambulatory patients only)
7. Self-reported pregnancy or planned pregnancy in the next 6 months
8. Inability or unwillingness to consent and/or follow requirements of the study
9. Planned major surgeries or procedures requiring hospitalization in next 6 months
10. Use of Lifevest or other worn device that may affect ballistocardiogram measurements
11. Patient weight \> 385 lbs at time of enrollment
12. Life expectancy \<1 year

Primary outcomes:
measure: Myia Platform feasibility: questionnaire
timeFrame: From baseline to 6 months (final)
Secondary outcomes:
measure: Persistence of minimally useful data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
timeFrame: From baseline to 6 months time (final)
measure: Persistence of daily data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
timeFrame: From baseline to 6 months time (final)
measure: Persistence of weekly data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
timeFrame: From baseline to 6 months time (final)
measure: Persistence of vital sign data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
timeFrame: From baseline to 6 months time (final)
measure: Persistence of greater than 1 data point per week data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.
timeFrame: From baseline to 6 months time (final)
measure: Medication management: total number of medication changes
timeFrame: From baseline to 6 months time (final)
measure: Medication management: length of time to medication change
timeFrame: From baseline to 6 months time (final)
measure: Medication management: target dose
timeFrame: From baseline to 6 months time (final)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Greg Ewald, MD
role: PRINCIPAL_INVESTIGATOR
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