Remote Monitoring of Multiple Indicators of Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Usability and Utility Assessment of Passive Remote Monitoring of Multiple Novel Indicators of Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Myia Health® remote patient monitoring unblinded treatment arm


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Device: Myia Health platform and in-home suite of devices®
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Remote patient monitoring<br>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 | Other: Myia Health® remote patient monitoring unblinded treatment arm<br>* After consenting to the study, the Myia in-home suite of devices 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. Device: Myia Health platform and in-home suite of devices®: Emfit Ballistocardiograph® Withings Connected Scale® VitalScout (VivaLink) ECG Accelerometer® Omron Blood Pressure Monitor® (Sphygmomanometer) Cradlepoint - Hotspot / Adaptor® (LTE Connection) Samsung Galaxy Tab A 8.0® (User Interface)<br>* Other names: Myia Health platform and in-home suite of devices®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myia Platform feasibility: questionnaire | Patient perception of the Myia Platform will be assessed during the study using a structured questionnaire, delivered either electronically or by paper to patients by research staff. Patient Platform satisfaction/usability/utility questionnaire: The formal title of the questionnaire is 'Check In Survey' and it consists of 17 questions with scaled options, 1-7 (1=most positive, 7=most negative) and it is administered at 3 time points. The lower the overall total the more positive the patient rating of the Myia Platform. | From baseline to 6 months (final) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of minimally useful data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure. | Acquisition of minimally useful data profile: Weeks where minimally useful data profile collected/total number of weeks. This endpoint will be defined retrospectively by the clinical team. | From baseline to 6 months time (final) | 
| Persistence of daily data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure. | Acquisition of any data point daily: Days with >1 data point collected/total number of days | From baseline to 6 months time (final) | 
| Persistence of weekly data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure. | Acquisition of any data point weekly: Weeks with >1 data point collected/total number of weeks | From baseline to 6 months time (final) | 
| Persistence of vital sign data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure. | Acquisition of continuous vital sign data variables daily: Days with >1 data point collected/total number of days | From baseline to 6 months time (final) | 
| 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. | Acquisition of continuous data variables weekly: Weeks with >1 data point collected/total number of weeks | From baseline to 6 months time (final) | 
| Medication management: total number of medication changes | Absolute count of heart failure medication changes per patient. This metric will be calculated on a per patient level. Any change in dose or frequency of medication will be considered a medication change. | From baseline to 6 months time (final) | 
| Medication management: length of time to medication change | Mean time to heart failure medication change per patient. Average time interval between a change to 1 or more heart failure drugs between the baseline and 6 month time points. | From baseline to 6 months time (final) | 
| Medication management: target dose | Distance from target dose of heart failure medication (< 50% target dose, 50%-75% of target dose, 75%-100% of target dose) The baseline use and dose of the following heart failure medication categories will be examined for each patient at baseline: Beta Blockers Digoxin ACE, ARB, ARNIs Hydralazine Nitrates Loop Diuretics Aldosterone Antagonists For each medication class, the presence and absence of absolute contraindications will be determined based on documentation in the medical record or as ascertained by study investigators. For each patient and each medication, available dose information will be reviewed in reference to recommended target doses by clinical practice guidelines. Distance to target dose will be assessed at baseline and follow-up. The difference in the relative proportion of people in the target dose categories will be compared between treatment and usual care groups. | From baseline to 6 months time (final) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NYHA II-IV, Reduced Ejection Fraction, Cardiology