WHY IS THIS STUDY BEING DONE?
Wearable sensor technology (e.g. smartwatches and activity monitors) is one of the fastest growing technology fields in the world. The University of Calgary launched Canada’s first wearables program in September 2018 called Wearable Technology Research and Collaboration (We-TRAC) Training Program. One of our main research aims is to redefine normative standards for sleep, exercise and overall activity levels. Since current wearable sensors now track many other health-related parameters such as sleep duration, activity intensity, types/modes of exercise, and heart rate, these data can easily be combined with the automatic tracking of an individual’s global position that correspond to where they live, work, and play. Therefore, modern wearable technology offers the opportunity to gather population-level data, across a wide spectrum of individuals in real-world conditions, in order to develop new normative standards.
We-TRAC researchers have built a web-portal to allow individuals to voluntarily upload their wearable technology data to a Level-4 secure research database housed at the University of Calgary. This database also serves the University’s research community as a way to safely and securely manage the large amounts of data generated from wearable technology devices. The development of this unique database at the University of Calgary offers us the opportunity to engage in a novel and transformative research program: one we call the Wearable Technology Citizen Science Program.
There are two aims to the Wearable Technology Citizen Science Program. For all participants, this study aims to use data from wearable technology to redefine normative standards for sleep, exercise and overall activity levels. The Level-4 secure server also serves the University’s research community as a way to safely and securely manage the large amounts of data generated from wearable technology devices.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
About 10,000 people will take part in this study Canada wide.
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
If you volunteer to participate in this study, the researcher will ask you to do the following:
Collecting Wearable Sensor Data (10-15 minutes)
This is a combined retrospective and prospective cohort study involving the collection of wearable sensor data for the 24 months prior to entering the study as well as the weekly prospective monitoring of your sleep, exercise and step count, and heart rate. The information collected will depend on your wearable device such that if your wearable device collects additional data (i.e. some devices record Pulse Oximetry (or Pulse Ox, for short) while others use heart rate data to calculate heart rate variability), then these data will also be collected.
For those of you who are currently participating in a research study
You will choose which study you are involved in using a pull-down menu. A list of approved studies will be listed including the Ethics ID number, title of the study, and name of the Principal Investigator (PI). You will next be prompted to enter your Research ID. If you do not know your Research ID, we will automatically contact the study PI and obtain this information. You are now finished and no other information from you is needed at this time. You may, however, be contacted by the research study PI, or their designate, in order to complete the data transfer process.
For those of you who are NOT currently participating in a research study
You will identify which devices you are currently using or have used over the past 24 months. You will be re-directed to the appropriate device manufacturer website to provide login information, to collect historical wearable data. By logging-in to the manufacturer’s website, you are giving the researchers permission to request a “User Token” from the manufacturer and thus access to all data stored within the manufacturers database for the past 24 months. This transfer will only include data that are routinely collected by your wearable device.
The User Token also allows for continued future weekly access to the manufacturer’s database in order to prospectively collect data until you decide to drop out of the study. Once the process of obtaining the User Token is complete (approximately 3-4 min per device), you will be taken back to the web portal where you will be given the option to add more devices. Once all devices are added, you will be prompted to complete short questionnaires regarding quality of life information, age, sex, weight, height, and the first 3-digits of your postal code/zip code.
In the background, the web-portal will download your data from the manufacturers database, to a maximum of 24 months’ worth of data, into the Level-4 secure server database at the University. Each week, the backend program runs to update the database you're your data. The User Token, and your participation in this study, can be revoked at any time by emailing Dr. Ferber (firstname.lastname@example.org) and requesting to withdraw from the study.
ARE THERE ANY POTENTIAL RISKS OR DISCOMFORTS THAT I CAN EXPECT FROM THIS STUDY?
Data Privacy – The data collected by the researchers would contain your movements and wearable sensor data. This may make it possible to identify your location (e.g. work, home, vacation, etc). However, all personal data will be stored in a separate database with a domain name separate from the web portal for improved security. As well, the University is storing all data in a level 4 secure database. Level 4 Security (L4S) is referred to as the most in-depth and highest security level technology for securing identities and identity documents. All stored data will be based on a unique research identifier string and not by an individual’s identifying information.
Access to the database is through Active Directory authentication only and two-factor authentication is required for local and remote access. The data that is being stored is classified as “Level-4 Restricted.” Administrative access to all data is limited to only three project personals (Service Owner (Ferber) and 2 administrators) for security reasons. Thus, only project administration staff can access the data and send to the other researchers. The database is monitored by Research Computing Services 24 hours a day and 7 days a week.
HOW LONG WILL I BE IN THIS STUDY?
The questionnaire and process of authorizing a User Token will take approximately 20-25 minutes to complete. You will only have to complete this process once. There is the possibility that you will be invited to participate in future approved research studies. You may be asked to participate in these research studies based on the wearable sensor data already collected by the procedures outlined above.
ARE THERE ANY POTENTIAL BENEFITS IF I PARTICIPATE?
If you agree to participate in this study, there may or may not be a direct benefit to you. Participation in this study may provide you with a deeper understanding of your sleep, exercise and overall activity patterns.
CAN I STOP BEING IN THE STUDY?
Your participation is voluntary, and you may withdraw from the study at any time and/or choose to not have your data used in any other study. You can also request that your data be removed up until such time as it is being used for data analyses and/or publication of research findings. To have your data removed, please by email Dr. Ferber (email@example.com) and requesting to withdraw from the study.
WILL INFORMATION ABOUT ME AND MY PARTICIPATION BE KEPT CONFIDENTIAL?
Your information will be kept confidential and secure. This consent document will be stored electronically on a password protected computer and accessible to Dr. Ferber and assigned study personnel. All data are being stored in a Level-4 secure server database. Level-4 Security (L4S) is referred to as the most in-depth and highest security level technology for securing identities and identity documents. As well, all data will be based on a unique research ID string and not by an individual’s name. Access to the database is through Active Directory authentication only and two-factor authentication is required for local and remote access. Only project administration staff can access the data and send to the other researchers. The database is monitored by Research Computing Services 24 hours a day and 7 days a week.
HOW LONG WILL INFORMATION FROM THE STUDY BE KEPT?
Data collected for this study may be shared with other researchers for future studies that are unknown at this time. Any data shared with other researchers, will not include your name or other personal identifying information.
Any future use of this research data is required to undergo review by a Research Ethics Board.
WHOM MAY I CONTACT IF I HAVE QUESTIONS ABOUT THIS STUDY?
The Research Team:
You may contact Dr. Reed Ferber at (403) 210-6468 with any questions or concerns about the research or your participation in this study.
Conjoint Health Research Ethics Board (CHREB):
If you have any questions concerning your rights as a possible participant in this research, please contact the Chair, Conjoint Health Research Ethics Board, University of Calgary at 403-220-7990.
AGREEMENT TO PARTICIPATE
Your decision to click the “AGREE” button will be interpreted as an indication of your agreement to participate. In no way does this waive your legal rights nor release the investigators or involved institutions from their legal and professional responsibilities. You are free to withdraw from the study at any time.