Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology (NCT06753045)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (12 items).
Location: East Jefferson General Hospital — New Orleans, Louisiana
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- East Jefferson General Hospital — New Orleans, Louisiana
- Tulane University Medical Group Clinics — New Orleans, Louisiana
- University Medical Center — New Orleans, Louisiana
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.