Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology
Recruiting · NCT06753045 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tulane University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.
Who can take part
Inclusion criteria
- Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke/Transient Ischemic Attack (TIA), or diabetes mellitus).
- Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study).
Exclusion criteria
- Participants who cannot read, speak, and/or understand English.
- Participants with cognitive impairments who are unable to give informed consent or sign their HIPAA form.
- Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
- Participants who are pregnant.
- Participants with tattoos, scars, or skin adhesions that would not allow for Photoplethysmography (PPG) recordings to be collected from a wrist-worn device.
- Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors).
- Participants with a pacemaker.
- Participants with allergies to watch and/or wristband materials.
- Participants with known plans to permanently leave the state of Louisiana within the observational period.
- Participants who have no known medical history with any of the enrolling institutions.
- Patients without a compatible smartphone (iOS 13 \& Android 11 at minimum).
Where it is running
6 locations listed across 1 US state.
- East Jefferson General Hospital - New Orleans, Louisiana, United States
- Tulane University Medical Group Clinics - New Orleans, Louisiana, United States
- University Medical Center - New Orleans, Louisiana, United States
- East Jefferson General Hospital - New Orleans, Louisiana, United States
- Tulane University Medical Group Clinics - New Orleans, Louisiana, United States
- University Medical Center - New Orleans, Louisiana, United States