Remote Monitoring of Multiple Indicators of Heart Failure

December 6, 2023 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Remote patient monitoring

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

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)

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
Time Frame: From baseline to 6 months (final)

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.
Time Frame: From baseline to 6 months time (final)
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.
Time Frame: From baseline to 6 months time (final)
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.
Time Frame: From baseline to 6 months time (final)
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.
Time Frame: From baseline to 6 months time (final)
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.
Time Frame: From baseline to 6 months time (final)
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
Time Frame: From baseline to 6 months time (final)
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
Time Frame: From baseline to 6 months time (final)
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
Time Frame: From baseline to 6 months time (final)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Healthcare Innovation Lab
MYIA Labs, Inc.

Investigators

  • Principal Investigator: Greg Ewald, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2020

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201908180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Myia Health® remote patient monitoring unblinded treatment arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe