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Wearable Technology in Heart Failure Patients (Wearables-HF)

2026年6月12日 更新者：Wilson Tang、The Cleveland Clinic

Integration of Wearable Technology Data in Patients With or at Risk of Heart Failure

The primary objective is to establish a Cleveland Clinic-led registry designed to integrate continuous physiological data from consumer wearables, captured by the HeartBit app and a Case Western Reserve University (CWRU)-based platform, with clinical data from patients' individual Electronic Health Record (EHR). This proposal is for understanding the use of personal wearable devices (such as: Fitbit, and Apple Watch) to gather physiological data (such as: heart-rate, steps taken, sleep cycles, and calories expended) and correlate those data with self-reported health status. The research team intends to collect all of the data generated by the participant's personal wearable devices and to perform an integrated analysis of the physiological data generated by the wearable devices. The investigators specifically aim to uncover patterns from the data that they can evolve models from. The investigators' goal is to better predict and diagnose the adverse effects associated with daily lifestyle, including cardiovascular risk, musculoskeletal, metabolic risks, stress, and sleep disturbances. These data may be used to better understand the daily habits and lifestyle choices to possibly predict a person's health and disease risk to provide a more comprehensive diagnosis with early recognition and prevention. As wearable devices become more accurate and cheaper to purchase for the general public, integrative analysis of wearable data from multiple devices may lead to models that can be used by clinicians and basic scientists to make inferences about the daily lifestyle and its effects on health and disease.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Jennifer Wilcox
  • 电话号码：216-636-6153
  • 邮箱：kirsopj@ccf.org

研究联系人备份

  • 姓名：Valesha Province, MS
  • 电话号码：216-636-6153
  • 邮箱：provinv@ccf.org

学习地点

  • 美国
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 招聘中
        • Cleveland Clinic
        • 首席研究员：
          • W. H. Wilson Tang, MD
        • 接触：
          • Valesha Province, MS
          • 电话号码：216-636-6153
          • 邮箱：provinv@ccf.org
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

This prospective, observational registry will enroll adult participants, aged 18 to 85 years, who have been diagnosed with heart failure or are identified as being at risk of developing heart failure. The study aims to enroll an indefinite number of participants at Cleveland Clinic.

描述

Inclusion Criteria:

  • Participants must be between 18 and 85 years of age.
  • Participants must have a diagnosis of heart failure or be identified as at risk of developing heart failure.
  • Participants must either own or be willing to acquire a compatible personal consumer-grade wearable device (such as Fitbit and Apple Watch) and must enroll via the HeartBit app.

Exclusion Criteria:

  • Individuals presenting with cognitive impairments or mental incapacity that would impede their understanding of, or cooperation with, the study protocol.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Establish Wearables Registry
大体时间：10 years
To establish a Cleveland Clinic-led registry that integrates continuous physiological data from consumer wearables, captured by the HeartBit app and a Case Western Reserve University-based platform, with comprehensive clinical and laboratory data from the Cleveland Clinic EHR.
10 years

次要结果测量

结果测量
措施说明
大体时间
Association between Wearable-derived Heart Rate and Clinical Outcomes
大体时间：10 years
To determine whether, and to what extent, changes in wearable-derived heart rate are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.
10 years
Association between Wearable-derived Physical Activity and Clinical Outcomes
大体时间：10 years
To determine whether, and to what extent, changes in wearable-derived physical activity are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.
10 years
Association between Wearable-derived Sleep Metrics and Clinical Outcomes
大体时间：10 years
To determine whether, and to what extent, changes in wearable-derived sleep metrics are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.
10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Cleveland Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2036年6月1日

研究完成 (估计的)

2040年6月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26-550
  • IRB 26-550 (其他标识符：Cleveland Clinic IRB)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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