Heart Failure
Conditions
Keywords
Heart Failure, Wearable Device, FitBit, Garmin, Apple Watch
Brief summary
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.
Interventions
None listed
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish Wearables Registry | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between Wearable-derived Heart Rate and Clinical Outcomes | 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. |
| Association between Wearable-derived Physical Activity and Clinical Outcomes | 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. |
| Association between Wearable-derived Sleep Metrics and Clinical Outcomes | 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. |
Countries
United States
Contacts
CONTACTValesha Province, MS
CONTACTJennifer Wilcox
Outcome results
None listed