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USC and Bodyport Remote Heart Failure Management Study

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bodyport Cardiac Scale
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keck Medical Center of USCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BodyPort Cardiac Scale

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in quality of life
Evaluating Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements at the time of hospital discharge and 90-days post-discharge
Scale Adherence
Measure of daily scale adherence

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2021
Last Updated
April 28, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04975633
Brief Title
USC and Bodyport Remote Heart Failure Management Study
Official Title
USC and Bodyport Remote Heart Failure Management Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BodyPort Cardiac Scale
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Bodyport Cardiac Scale
Intervention Description
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 Outcome Measure Information:
Title
Change in quality of life
Description
Evaluating Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements at the time of hospital discharge and 90-days post-discharge
Time Frame
Up to 14 days after enrollment and approximately 90-days post-enrollment
Title
Scale Adherence
Description
Measure of daily scale adherence
Time Frame
Through study completion, approximately 90 days
Secondary Outcome Measure Information:
Title
Patient and provider satisfaction
Description
Assessing patient and provider satisfaction with the Bodyport virtual cardiac clinic at USC Keck Medicine through semi-structured interviews
Time Frame
Through study completion, approximately 90 days for patients and an average of 9 months for providers.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Yadzi, MD
Phone
650-200-1557
Email
daniel@bodyport.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Fong, MD
Organizational Affiliation
Keck Medical Center of USC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Ramos, RN, BSN, CCRP
Phone
323-442-7983
Email
Melissa.Ramos@med.usc.edu

12. IPD Sharing Statement

Learn more about this trial

USC and Bodyport Remote Heart Failure Management Study

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