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临床试验/NCT05900362
NCT05900362尚未招募不适用

Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

Saint Luke's Health System8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
8
主要终点
Compliance with monitoring protocol

研究概览

简要总结

Previous research has investigated the use of remote patient monitoring in various clinical contexts, however there has not been a clinical trial examining use of the VitalCare platform for ambulatory management of heart failure. This trial will serve as a pilot study examining the feasibility of use of the VitalCare platform for ambulatory heart failure management and examine the effect of remote patient monitoring on patient engagement. To the investigators' knowledge, this will be the first study examining the effect of remote patient monitoring with the VitalCare platform on heart failure clinical outcomes, such as hospitalization for heart failure exacerbations and emergency room visits for heart failure.

详细描述

The next step in determining the role of remote patient monitoring in the management of patients with heart failure is to better understand which patients are most likely to benefit from a more intensive outpatient management or simply conservative management. The subject population is patients with mild HFrEF or HFpEF who are prone to readmission. This patient population does not have implanted devices to supply objective data to evaluate patient's volume status and therefore can be challenging to manage on an outpatient basis. By providing regular data on weight, blood pressure, pulse oximetry, electrocardiogram and heart/lung sounds that is reviewed on a monthly basis, this may allow a clinician greater insight into their patient's clinical status and allow for a more accurate and timely intervention to prevent clinical deterioration. Furthermore, this should enhance patient engagement with their own health as well as with their healthcare provider. This study would significantly add to the current knowledge of management of heart failure in an ambulatory patient population without implanted devices.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A clinical diagnosis of heart failure
  • New York Heart Association Class II or III congestive HF symptoms
  • Admission to hospital within 12 months for symptomatic heart failure.
  • Own a smartphone or tablet or comfortable with using one
  • English as primary language
  • Able to provide informed consent

排除标准

  • Left Ventricular Ejection Fraction < 35%
  • Implanted cardiac device (permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), chronic resynchronization therapy (CRT), implantable loop recorder (ILR))
  • CardioMEMS
  • Left ventricular assist device (LVAD)
  • NYHA Class I or IV congestive HF symptoms
  • Listed for cardiac transplant
  • Pregnant at time enrollment
  • End-stage renal disease

结局指标

主要结局

Compliance with monitoring protocol

时间窗: 6 month

Actual rate of completed patient data transmissions is greater than or equal to 60% of the expected rate of patient data transmissions (BP, HR, Weight, EKG)

次要结局

  • Patient engagement as measured by Patient Activation Measure(6 months)
  • Heart failure hospitalizations, emergency room visits for Heart Failure as compared to prior to trial enrollment(6 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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