Frequently asked questions
Your Guide to the HEARTBEAT Study
Discover key insights and answers to commonly asked questions about participating in the HEARTBEAT Study.
Frequently Asked Questions
Find answers to the most common questions about the HEARTBEAT study.
What is the HEARTBEAT study?
- The HEARTBEAT study by the Tulane Research Innovation for Arrhythmia Disorders (TRIAD) in collaboration with Samsung Research America, tests the relationship between biological signals collected on a Samsung Galaxy Smartwatch and heart-related health problems which may help enhance the prediction, identification, and understanding of cardiovascular diseases and comorbidities.
- Individuals who are above 18 years of age and have one or more heart-related health conditions may be eligible to participate. They will be provided a Samsung Galaxy Smartwatch and use the Heartbeat app installed on any compatible smartphone to complete daily health checks and occasional surveys.
What are the goals of the study? What are researchers seeking to understand?
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- The HEARTBEAT project is an observational prospective cohort study leveraging Samsung Galaxy Smartwatches to study the association between different biometric signal patterns and the incidence of cardiovascular events.
- Other study goals include:
> Establishing biometric fingerprints for disease identification and labeling.
Who is involved in the HEARTBEAT study?
- Samsung Research America and Tulane University doctors researchers, and engineers are collaborating to conduct the HEARTBEAT study. Alcedis is providing the electronic data collection system and HUMA is designing the HEARTBEAT app. Kajeet operates the distribution program for the watches.
How long will the study last?
- The duration of the study will be one year for each participant. During this time, patients will be followed up for one year using a Samsung Galaxy Smartwatch and a companion smartphone application. Electronic medical records (EMR) will be surveyed for medical and clinical patient data.
What are wearable devices and why are they important?
- Currently, about 20% of the U.S. adult population utilizes digital health technologies which has revolutionized the field of cardiovascular monitoring. These devices can monitor or predict a range of cardiovascular parameters such as heart rate, blood pressure, and blood oxygen saturation. This advancement is not only significant for its non-invasive nature but also for its potential to monitor and predict health status changes, offering a rich array of clinically relevant data.
Data Privacy FAQs
Why will participant data be collected?
- Sharing participant data in this study will allow us to answer our research questions.
What data will be collected?
- HEARTBEAT Study participants are asked to share different kinds of data and information.
- This includes:
- Information they enter in the HEARTBEAT app, including their contact information, demographic information, surveys, and general health history.
- Data from the Samsung Galaxy Smartwatch (if applicable) they use during the study, including health and activity metrics, health sensor metrics, and device usage.
- Information in the electronic medical record.
- Full details are included in the study consent form.
Will the study collect data from participant electronic medical records (EMR)?
- An electronic health record (EHR) is a digital version of a patient’s medical chart. Yes, this study will be collecting, analyzing or using data from participants’ EHR.
Who will have access to participant data?
- The information collected during this study will be viewed only by a carefully selected team of researchers and medical experts who are directly involved in this project. Each team member has undergone thorough training in handling sensitive information and is committed to upholding the highest standards of confidentiality and privacy, adheres to both HIPAA and other relevant US laws that protect your personal information.
- Moreover, we follow Tulane University’s stringent policies regarding the safe and private handling of data. Your personal details, such as your name and contact information, will be removed from the data, making it anonymous before it is used for any research analysis or shared for academic purposes. This ensures that no one outside of the immediate research team can link any part of the study data back to you.
- We take your privacy and security very seriously. With robust security measures in place, we provide a secure environment for all participants, ensuring that your contribution to this important research is safe and your information is protected at every step.
- Full details on other individuals and entities that may have access to the study data are included in the study consent form which participants were required to read and sign if they wanted to join the study.
How will participant data be kept secured?
- All study data collected is stored encrypted in a study database retained by an authorized third-party company. The third party company is required to protect the privacy and security of the study data. Records of participation in this study, including participant study data, will be kept confidential except if disclosure is required by law, or is otherwise required or allowed as described in the study consent form.
- Participant privacy and the confidentiality and security of participant data are important to us. We’ll make every reasonable effort to keep participant information safe and protect the confidentiality of that data; however, total confidentiality cannot be guaranteed. There is still a risk of unauthorized access to or disclosure of personally identifiable participant information, including health information.
How long will participant data be stored?
- The study data will be stored for the minimum amount of time necessary for the purposes of the study (as described in the study informed consent form), but no more than 50 years after completion of the study.
About the Samsung Galaxy Smartwatch
How will the Samsung Galaxy Smartwatch be used in this study and what will participants need to do?
- Participants need to wear the watch every day for 1 year.
- Participants will contribute to the work researchers are doing to understand whether the features on the Samsung Galaxy Smartwatch can help with early detection of heart related health conditions.
Where can I learn more about the Samsung Galaxy Smartwatch?
- Learn more about the Samsung Galaxy Smartwatch here.
Can I still participate if I wear a smartwatch from another company?
- Yes, you can still participate in the study if you use another smartwatch. However, for the purpose of our research, you will need to wear the Samsung Galaxy Smartwatch that we provide, as it’s equipped with specific sensors and software necessary for this study. You can wear both watches at the same time if you like—just on different wrists. We recommend wearing the study watch every day to ensure accurate data collection for the research.