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临床试验/NCT04975633
NCT04975633已完成不适用

USC and Bodyport Remote Heart Failure Management Study

University of Southern California2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Change in quality of life

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in quality of life

时间窗: 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

时间窗: Through study completion, approximately 90 days

Measure of daily scale adherence

次要结局

  • Patient and provider satisfaction(Through study completion, approximately 90 days for patients and an average of 9 months for providers.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael William Fong

Associate Professor of Clinical Medicine

University of Southern California

研究点 (2)

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