Participants Guide
This guide acts as a template for researchers to provide participants with important information for their participation at the data collection. It is recommended to adjust below template based on study specifics.
About the Study
We are excited about your participation at the study. The study objectives and design is as follows:
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Participation Requirements
To be invited to this study, you need to be at least 18 years old; fluent in reading [language]; study at [institution], and currently live in [location]. You need to have a smartphone that runs on Android or iOS.
The study may not be suitable for some people because they may experience distress from participating. To ensure that this study is a good fit for you, we will ask you a few short questions after the information materials and informed consent before we can invite you to the study.
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Advantages and Disadvantages from Participation
You can gain several benefits from participating in our study which are [benefits/compensation].
A possible disadvantage of participation is that [disadvantages, e.g. time invest].
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Possibility to Stop Participation
Participation is completely voluntary. You are free to stop participation at any time, without having to provide a reason (although you are free to do so of course). The data collected before will still be used for our research unless you ask us to delete it.
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Use of Data
During the course of the study, your health and activity data will be collected by the Garmin device. The data will include the following:
– Health information such as heart rate, stress levels, sleep, body battery, etc.
– Activity information such as step count, distance travelled, floors climbed, active minutes, recorded workouts, etc.
– Location information will only be recorded during a workout that needs to be started and ended on your Garmin device.
The study will analyse and publish the data as follows:
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About the Garmin Device
You will be equipped with a Garmin device that is going to automatically record your health and activity data. To support this process you should follow these rules:
– wear the device day and night (device is waterproof, this means that you can also wear it during shower or swimming but not for diving).
– charge the device regularly (at least every 4-5 days).
– sync the device daily (see section below on sync process).
– do not connect the Garmin device to any other app or Internet service other than instructed by the study protocol. Particularly, do not connect the Garmin device to “Garmin Connect” unless specifically instructed to do so.
– follow instructions received through push notifications.
– immediately complete questionnaires when received.
Setup Garmin Device
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Your Garmin device needs to be paired with your smartphone to allow data synchronization.
Alternative A) Pair with Fitrockr app
To pair the Garmin device with the Fitrockr app, follow these steps:
(1a) for iOS, download the “Fitrockr Hub – Garmin Sync” app from the App store.
(1b) for Android, download the “Fitrockr Sync” app from the Play store.
(2) approve all access requests by the app (such as camera access, etc.).
(3) scan the QR code that you should have received from study personnel.
(4) follow pairing instructions in the app to connect the Garmin device.
If pairing fails, try again. If the issue cannot be resolved, contact us.
Alternative B) Pair with Garmin Connect
To pair the Garmin device with the “Garmin Connect” app, follow these steps:
(1) download the “Garmin Connect” app from the Play or App store.
(2) register an account in Garmin Connect.
(3) follow pairing instructions in the app to connect the Garmin device.
(4) you will receive a “join-link” from study personnel. Follow the link to approve data sharing.
If pairing fails, try again. If the issue cannot be resolved, contact us.
Alternative C) Preconfigured Device
You will receive a preconfigured device that you just need to wear. There are no actions required to set up the device.
Sync Garmin Device
Your Garmin device will record all your activity and health information and store it on its internal storage. To provide researchers access to the data, you need to synchronize the Garmin device daily. It is no problem if you forget to synchronize it on a day. Just synchronize it on the next day.
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Alternative A) Participant sync via Fitrockr app
To synchronize the Garmin device, you need to open the Fitrockr app on your smartphone. The synchronization will start automatically. Wait until the synchronization has finished. Then minimize or close the app.
If sync fails, try again. If the issue cannot be resolved, contact us.
Alternative B) Participant sync via Garmin Connect
To synchronize the Garmin device, you need to open the Garmin Connect app on your smartphone. The synchronization will start automatically. Wait until the synchronization has finished. Then minimize or close the app.
If sync fails, try again. If the issue cannot be resolved, contact us.
Alternative C) Sync by Study Personnel
To synchronize the Garmin device, study personnel will contact you and conduct the synchronization.
Notifications & Questionnaires
During the data collection period, you will receive push notifications and questionnaires in the Fitrockr app. Please follow instructions given through notifications and immediately complete any questionnaires that you receive.
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Third Parties Involved
There are third parties involved in the research process. They will have access to parts of your data, and have signed strict data processing agreements or independent controller-controller agreements.
During the data collection phase, Fitrockr Health Solutions (a Germany based Software company) will obtain the Garmin research data and questionnaires provided via the Fitrockr app for us.
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General Information About Data Use and Storage
We only use methods approved by our IT Security and apply strict organizational measures regarding access rights, encryption, and security. All data are stored and processed in accordance with all rules and guidelines of the European General Data Protection Regulation (GDPR) in a well- secured manner. While privacy risks such as a data breach are minimal, they can never be fully ruled out. Please take this into consideration when deciding whether to participate in the study. When you sign the declaration of consent, you consent to the collection, storage, and use of both your personal and research data in the above-outlined ways.
This research is conducted by [organization], which is responsible for the data processing. Questions, comments or complaints concerning the way your data are handled can be addressed to the responsible researchers at [contact] or the Data Protection Officer at [contact].
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Funding Authority
The study is funded by [funding authority].
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Contact
In case of questions or issues, please contact the study coordination at:
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