Study Info
What are we trying to study?
The Just in Time Project is looking to collect information on the electrical activity of the heart within the American Indian/ Alaskan Native (AI/AN) population via a recording called an electrocardiogram (ECG) by placing a remote heart monitor on the chest.
Why are we studying this?
This type of information does not exist currently but can provide valuable insights to the challenges and issues that the AI/AN population experiences when attempting to access healthcare services like remote heart monitoring. Many Arizona tribal members live or work in rural areas that may affect how a remote monitoring device collects heart activity and provides "just-in-time" intervention, so one can seek medical help immediately, especially if that device relies on broadband or wifi access. It's important to understand these issues so a better way to provide this service can be created.
The ultimate goal is to use the information collected to help develop a more accurate prediction and intervention model along with a more accessible communication system.
Where is the study located?
Locations of where study participants can meet include but are not limited to: Flagstaff, Cameron, Tuba City, and LeChee, Arizona.
What does the study look like?
Participants in this study will be asked to do the following:
Meet with our team to sign a consent form and enroll in our project. You will be asked to provide a brief health history and complete our demographic form. (1 hour)
Receive and wear the BodyGuardian Mini remote heart monitoring device for 14 days. During the 14 days, they will keep record of their activities and any symptoms in a holter diary.
Activities like sitting, walking, strenuous exercise, eating, sexual activity, taking medications, etc.
Any symptoms like chest pain, back pain, dizziness, nausea, other pain — whether or not you feel they are important.
Write the time of day for every activity or symptom that you record on the diary
Upon completion of the 14 days, return the monitor and complete a post survey. (1 hour)
Receive a $100 gift card.
What type of Remote Heart Monitor will be used?
An example of the placement of a BodyGuardian MINI.
Our team intends to use an FDA-approved heart monitor called the BodyGuardian MINI. Created by Boston Scientific/Preventice Solutions, this device is an easy-to-use, wearable, and waterproof patch that can be moved and reapplied as needed to ensure that participants have as little discomfort as possible.
Throughout the course of our two-week study, patients will wear the BodyGuardian MINI to help us collect cardiac data and provide feedback on their experience wearing the device.
The device records the signal and stores it for up to 14 days. The information stays on the device till it is downloaded manually. At this time, there is no intervention or alarm.
What are the Requirements To Participate?
In order to participate in the two-week feasibility study, you must meet these criteria:
Must be an American Indian adult (over 18 years of age)
Live and/or work in remote or tribal regions in Arizona
Have a health history of at least one of the following:
High Blood Pressure (HBP)
Atrial Fibrillation (AF)
Congestive Heart Failure (CHF)
What will happen to the information collected?
Data Management and privacy are of upmost importance. The information collected will be used solely for this project. No data will be shared or stored for future or commercial use.
Names will not be used in any report. Participants will be assigned a unique identifier that does not contain any identifying information. Study records will be encrypted, and password protected. Only the research team will have access to the files. When the study is completed and the data have been analyzed, anything with identifiable information will be destroyed.
The following information will be collected:
Electrocardiogram (ECG) signal will be collected and stored on the remote heart monitoring device. The device is not connected to the cloud and NO information will be sent to the cloud.
Demographic information will be collected
Holter Diary information will be collected.
A Survey regarding your experience will be taken.
No specimens will be collected.
Participants will receive any clinically relevant results from the study team and we can send those results to your medical provider, if needed.
Deidentified ECG signals and Holter Diary information will be evaluated to develop machine learning and signal processing algorithms. Demographics and surveys will be used to determine if a larger study of this kind can be performed.
Other References
A study conducted by Dr. Suneet Mittal, MD, illustrates the importance of the BodyGuardian MINI's lengthened monitoring capability: https://www.prnewswire.com/news-releases/duration-of-external-ecg-monitoring-is-critical-to-detecting-atrial-fibrillation-300844657.html
Patient testimonials for the BodyGuardian MINI: https://www.preventicesolutions.com/us/en/patients/patient-stories.html
Relevant Studies
Summary: In this study conducted by the University of Michigan, researchers developed a mobile app to where patients with Afib could log their daily symptoms. Typically, doctors have their patients recall their previous symptoms at their appointments, but this is not a reliable way to make sure all symptoms can be evaluated to the fullest extent as people may forget things. The study finds that patients were able to easily use the application and that the application could be a helpful tool for doctors to have the most relevant and up-to-date data possible for a patient's treatment.
JAFB-AFib Feas Study.pdfSummary: In this study conducted by the University of Michigan and Toyota, researchers explored the potential for developing a heart monitoring system that can be deployed in vehicles to decide if a cardiac event has occurred while an individual is driving. If a cardiac event happens while someone is driving, it poses an even greater risk to the driver and other people on the road. They utilized the BodyGuardian sensor that we intend to use for our pilot study to collect cardiac data. The researchers find that it is feasible to develop a system that utilizes a cardiac sensor to build car safety features based on this data.
Feasibility Study for In-Vehicle Detection of Severe Cardiac Events.pdfSummary: In this study conducted by researchers at the University of Michigan, the authors collected cardiac data from 45 patients for up to 3 weeks. This data was used to develop a machine learning method that can detect Afib events before they occur. The method developed is capable of detecting Afib events up to 4.5 minutes before the event starts, allowing for patients to receive earlier care to potentially reduce the morbidity and mortality rates associated with these events.
BMC - Predict AFib.pdf