Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology
ConditionHeart Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorTulane University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
This study will include 10,000 patients older than 18 years who will either be healthy or with a pre-existing heart condition.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Smartwatch
Other interventionSensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Cohort arm1 intervention
Group B: Healthy arm1 intervention
Trial outcomes
Primary outcomes
1
The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions
These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.
Time frame
1 Year2
The incidence of new cardiovascular diseases events
These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence and check to confirm if the patient developed a new cardiovascular disease. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.
Time frame
1 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tulane University
Lead sponsor
Samsung Electronics
Collaborator
Source ClinicalTrials.gov