Remote Monitoring of Multiple Indicators of Heart Failure

The Washington University

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Other: Myia Health® remote patient monitoring unblinded treatment arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04267744

201908180

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

Remote patient monitoring

Other group

Description:

After consenting to the study, the Myia in-home suite of devices, and mobile phone application if the patient owns a smart phone, will be provided to all recruited patients. The data flowing from the Myia platform will be available to clinicians and patients for the duration of the pilot and utilized to complete study activities. Patients enrolled will transmit daily vital sign data to the Myia Health remote patient monitoring platforms for clinical review. Enrolled patients will complete medication change/compliance survey monthly to assess for medication changes. Enrolled patients will complete symptomatic assessments (KCCQ-12) at 0, 3, and 6 months. Enrolled patients will complete a Check-In survey to assess utility and usability of the intervention at the 2, 4, and 6 month timepoints

Treatment:

Other: Myia Health® remote patient monitoring unblinded treatment arm