USC and Bodyport Remote Heart Failure Management Study

A feasibility study investigating the Bodyport virtual cardiac clinic vs usual care for outpatient heart failure management at Keck Medical Center of USC

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Bodyport Cardiac Scale

Detailed Description

Heart failure is a debilitating disease associated with high hospitalization rates which could potentially be curbed by remote patient monitoring. Remote monitoring may allow for the early detection of signs and symptoms of cardiac decompensation, enabling prompt interventions to reduce hospital admission rates or the duration of inpatient stay, and the quality of life of those suffering from heart failure. Recent studies have demonstrated that structured remote patient management interventions can reduce the percentage of days lost to unplanned cardiovascular admissions. The investigators propose assessing the feasibility of a structured virtual cardiac care service leveraging the Bodyport platform to optimize outpatient management of heart failure.

This study will leverage the Bodyport virtual cardiac clinic platform to deliver care for the heart failure patient population at Keck Medical Center of USC. Patients randomized to the intervention arm will receive the Bodyport Cardiac Scale for home monitoring as well as heart failure education and non-clinical support from Bodyport coaches. Daily measurement uploads from the patients will be analyzed and changes in measurement data will be used to guide follow-up and care management, such as diuretic dose adjustments. For this initial feasibility study, the investigators will be focusing on patient and provider satisfaction of the virtual cardiac clinic along with the operational ease of executing this form of care compared to standard care.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of HFrEF or HFpEF and hospital discharge for a heart failure exacerbation within 14 days of enrollment.
• 18 years of age or older
• English speaking
• Able to safely stand on the Bodyport scale
• Patients must have a reliable and working phone for communication with the care team
• All patients should have access to the internet via a computer or mobile device to access the Bodyport care platform
• Patients must have a safe and secure place to store the Bodyport device

Exclusion Criteria:

• Weight >375 lbs.
• History of repeatedly missing follow-up appointments or being unreachable by phone
• Inability to stand on the Bodyport scale for the duration needed to capture data
• Patient in jail or currently homeless
• Known or documented noncompliance with medical therapy
• Unable to speak English
• Unable or unwilling to answer survey questions
• History of heart transplantation
• Chronic kidney disease stage IV or V and/or on hemodialysis
• Presence of a ventricular assist device
• Presence of a CardioMEMs pulmonary artery sensor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BodyPort Cardiac Scale; Patient will receive the Bodyport scale with access to Bodyport care services, such as remote monitoring, educational materials, different biomarkers detected by the scale, and online access to their data	Device: Bodyport Cardiac Scale; Patients will be instructed to take daily measurements for 90 days. Data will be transmitted to Bodyport and concerning findings (weight gain, change of impedance, elevated heart rate) will be reported back to the medical team. The medical team will either choose to act on the information given or continue to observe trends. Interventions may include titration of therapy, change in therapy, fluid restriction, sodium restriction and lifestyle modification
No Intervention: Control; Patients will receive usual care and a Bodyport scale that only displays weight and weight change. No other access to care services, features, or materials will be provided during this 90 day period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Evaluating Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements at the time of hospital discharge and 90-days post-discharge	Up to 14 days after enrollment and approximately 90-days post-enrollment
Scale Adherence	Measure of daily scale adherence	Through study completion, approximately 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and provider satisfaction	Assessing patient and provider satisfaction with the Bodyport virtual cardiac clinic at USC Keck Medicine through semi-structured interviews	Through study completion, approximately 90 days for patients and an average of 9 months for providers.

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Michael W Fong, MD, Keck Medical Center of USC

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HS-21-00032

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: Yes
• product manufactured in and exported from the U.S.: No