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临床试验/NCT07650669
NCT07650669招募中不适用

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

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Establish Wearables Registry

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Establish Wearables Registry

时间窗: 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.

次要结局

  • Association between Wearable-derived Heart Rate and Clinical Outcomes(10 years)
  • Association between Wearable-derived Physical Activity and Clinical Outcomes(10 years)
  • Association between Wearable-derived Sleep Metrics and Clinical Outcomes(10 years)

研究者

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

Wilson Tang

Staff, HBKR, Cleveland Clinic Research & Staff, Heart Failure, Cardiovascular Medicine

The Cleveland Clinic

研究点 (1)

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