Heart FailureNCT04975633
USC and Bodyport Remote Heart Failure Management Study
A study testing Bodyport Cardiac Scale in people with Heart Failure, run by University of Southern California at 1 site in United States.
Trial summary
A feasibility study investigating the Bodyport virtual cardiac clinic vs usual care for outpatient heart failure management at Keck Medical Center of USC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Bodyport Cardiac Scale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 5 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck Medical Center of USC
Los Angeles, California, 90033
About this study
A feasibility study investigating the Bodyport virtual cardiac clinic vs usual care for outpatient heart failure management at Keck Medical Center of USC
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Bodyport Cardiac Scale
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodyport Cardiac ScaleDevice
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
| Study group | Role | What they receive |
|---|---|---|
| BodyPort Cardiac Scale | Experimental | 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 Receives: Device: Bodyport Cardiac Scale |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Evaluating Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements at the time of hospital discharge and 90-days post-discharge
Measured: Up to 14 days after enrollment and approximately 90-days post-enrollment
Scale Adherence
Measure of daily scale adherence
Measured: Through study completion, approximately 90 days
Secondary outcomes (1)
Patient and provider satisfaction
Assessing patient and provider satisfaction with the Bodyport virtual cardiac clinic at USC Keck Medicine through semi-structured interviews
Measured: Through study completion, approximately 90 days for patients and an average of 9 months for providers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start10 May 2021
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael William Fong, University of Southern California
- Investigators
- Michael W Fong, MD, Principal investigator, Keck Medical Center of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975633
- Sponsor's protocol ID
- HS-21-00032
- Status last verified
- Feb 2025
- First submitted
- 24 May 2021
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USC and Bodyport Remote Heart Failure Management Study
- ClinicalTrials.gov ID
- NCT04975633
- Acronym / sponsor ID
- HS-21-00032
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BodyPort Cardiac Scale | Experimental | Device: Bodyport Cardiac ScalePatient 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 |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodyport Cardiac ScalePatients 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 | Device | BodyPort Cardiac Scale |
Primary outcome
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
Scale Adherence
Time frame: Through study completion, approximately 90 days
Measure of daily scale adherence
1 secondary outcome
Patient and provider satisfaction
Time frame: Through study completion, approximately 90 days for patients and an average of 9 months for providers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W Fong, MD principal investigator
Keck Medical Center of USC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bodyport Cardiac Scale in people with Heart Failure, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Up to 14 days after enrollment and approximately 90-days post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.