After numerous internal, external, and collaborative research studies, we have distilled a number of steps and best practices that we have found work best in running robust studies using Health Tags.
Step 1: Contact Spire Health Sales Team to purchase access
If you haven't yet purchased access to the Spire Health Research Platform, please contact the Spire Health Sales Team at [email protected].
Step 2: Log in to the Research Portal
Once you have purchased access, you will need to create a Research account on the Spire Health Research Platform. Follow these steps:
-- Download the Spire Health Tag mobile application
-- Create an account
-- Send your Spire Health Sales Associate with your account information
You will then receive an email with instructions to log in to the Research Portal; from there, you can view and download reports, or obtain your unique API access token to being using the APIs.
Step 3: Conduct a small, internal pilot
We suggest using Health Tags internally and monitoring adherence on the Portal and downloading data before you begin bringing on research subjects. This will give you a good feel for what your study participants will experience and will help you address the idiosyncrasies of your audience and the technology in question.
Your pilot may not be long in duration. In fact, it may include solely setup and wearing Health Tags for a few minutes. But it's useful to go through the entire setup process to get a sense of what your participants will encounter.
(Note: These instructions do not include regulatory advice. Please consult your Institutional Review Board for advice on collecting data from any participants or even study personnel.)
Step 4: Distribute Spire Health Tags to study participants
Researchers who purchase access to the Research Platform automatically have included Health Tags for their study participants. Typically, 8 Tags will be sent per participant, usually shipped to a single research site (though other arrangements can be discussed - see below). If you haven't received Health Tags yet, please contact your Spire Health Sales Associate to monitor the status of your order.
If your research participants are distributed across multiple locations, you may consider having Spire Health mail devices directly to participants for an additional fee. Please ask your Spire Health Sales Associate for more details.
Step 5: Ensure that participants have registered their devices
Once participants receive Health Tags, they will need to download the Spire Health Tag app on their smartphone (or possibly tablet, consult Spire Health Support), create an account, and follow the in-app instructions to apply and pair Health Tags to their smartphone and user account.
Researchers with access to the Portal can then log in to Research Portal and view the Device Compliance report to check whether participants have paired the devices. If participants have not paired their devices, you may need to contact them directly to provide specific instructions and/or guidance.
Once participants pair their Health Tags to their Spire Health account, the data collected through their Health Tags become available for access via the API and Research Portal.
Step 6: Monitor your study participants actively
Each study is different and the assumptions you make about attrition and adherence will vary with other researchers, study designs, and populations. For example, your study may require participants to wear devices for a certain duration on a daily basis for several weeks, months, or longer.
While Health Tags offer best in class adherence due to their form factor, it is still important to monitor your subjects to ensure you are getting the best data you can.
Log in to the Research Portal and view the User Compliance report to verify whether participants are wearing devices on daily basis. If participants are not wearing devices for the duration required, you can contact them outside of the Research Portal.
Step 7: Ensure your participants' Health Tag data is being synced to the cloud"
Spire Health Tags are able to store approximately 1 day of processed data on the device itself before requiring offloading of sensor data to a mobile phone (via Bluetooth). If it not offloaded within this timeframe, new sensor data will overwrite old data. Participants should be instructed to keep their smartphones in the same room while wearing Health Tags to ensure consistent data capture and syncing.
Login to the Research Portal and view the User Compliance report to verify the number of 'Worn Hours' listed. If you notice a low number of worn hours, you may need to contact your participants to ensure that their smartphones are in the same room or nearby, they haven't terminated the app on the phone, and they are wearing their Health Tags.
Please note that Spire Health Tags are able to store ~45 minutes of unprocessed (raw) data. If you are collecting unprocessed data from your participants, please consult your Spire Health Sales Associate to identify a specific strategy to ensure consistent syncing for the duration of your research study.