Remote Monitoring of Multiple Indicators of Heart Failure

NCT04267744 | Unknown

• 1 other identifier: 201908180
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

NYHA II-IV; Reduced Ejection Fraction; Cardiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Persistence of minimally useful data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.

  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.

  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.

  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.

  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.

  From baseline to 6 months time (final)

Study Arms (1)

Remote patient monitoring

OTHER

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

Interventions

Myia Health® remote patient monitoring unblinded treatment arm OTHER

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)

Also known as: Myia Health platform and in-home suite of devices®

Remote patient monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Healthcare Innovation Lab: collaborator
• MYIA Labs, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (17)

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  PMID: 22009099 BACKGROUND

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  PMID: 20193826 BACKGROUND

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  PMID: 20142027 BACKGROUND

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• Greene SJ, Fonarow GC, Butler J. Reply: Titration of Guideline-Directed Medical Therapy Improves Patient-Centered Outcomes in Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 10;74(10):1426-1427. doi: 10.1016/j.jacc.2019.06.061. No abstract available.

  PMID: 31488284 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Greg Ewald, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Device: Myia Health platform and in-home suite of devices®

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 13, 2020
• Study Start: February 11, 2020
• Primary Completion: July 31, 2024
• Study Completion: August 1, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)