Clinical trial NCT04975633: USC and Bodyport Remote Heart Failure Management Study
Official title: USC and Bodyport Remote Heart Failure Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in quality of life
timeFrame: Up to 14 days after enrollment and approximately 90-days post-enrollment
measure: Scale Adherence
timeFrame: Through study completion, approximately 90 days
Secondary outcomes:
measure: Patient and provider satisfaction
timeFrame: Through study completion, approximately 90 days for patients and an average of 9 months for providers.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
Study officials:
affiliation: Keck Medical Center of USC
name: Michael W Fong, MD
role: PRINCIPAL_INVESTIGATOR
References: