Skip to main content
OpenTrials
Completed

NCT Number: NCT04975633

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bodyport Cardiac Scale

Device

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

Primary outcomes

  1. Change in quality of life

    Time frame: Up to 14 days after enrollment and approximately 90-days post-enrollment

    Evaluating Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements at the time of hospital discharge and 90-days post-discharge

  2. Scale Adherence

    Time frame: Through study completion, approximately 90 days

    Measure of daily scale adherence

Secondary outcomes

  1. Patient and provider satisfaction

    Time frame: Through study completion, approximately 90 days for patients and an average of 9 months for providers.

    Assessing patient and provider satisfaction with the Bodyport virtual cardiac clinic at USC Keck Medicine through semi-structured interviews

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2021
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.