Wearable Technology in Heart Failure Patients
Recruiting · NCT07650669 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States