Frequently Asked Questions about Participating in the Digital Mental Health Study (Phase 2) at UCLA
- What questions do I need to answer online in order to determine eligibility?
We will ask you about your age, sex, race and ethnicity, about whether you are fluent in English, whether you are a registered patient of the UCLA Health System or a UCLA student, about your personal smartphone, and certain medical conditions. Answers to these questions will help us determine if you are eligible to participate in this study, at this time. If you are not eligible at this time, you will be asked if you are interested in being contacted if enrollment re-opens.
- Why am I not eligible at this time?
If you are not older than 18, are not fluent in English, do not own a certain model of iPhone with access to data plan and Wifi, are not a registered patient of the UCLA Health System or a matriculating UCLA student, have certain health conditions, or are not willing to follow study instructions, you are not eligible to participate in our research study. As part of our study goals, we are attempting to recruit a sample of patients that is representative of the UCLA Health System and UCLA Student Body. This means that we are looking to enroll participants with a variety of demographic characteristics. You may be found to not be eligible at this time if we have enrolled enough participants sharing your demographic characteristics.
- Is this study available in languages other than English?
The study is currently only available in English.
- Will my doctor know if I participate in this study?
No, your doctor will not know about your participation in this study. Although you can discuss your participation with your health care doctor, we are committed to keeping your participation in this study confidential.
- I don’t live in L.A. Can I still be in the study?
Participants who are current UCLA Health System patients or UCLA Students are eligible to participate in the study. Research assessment visits will be conducted remotely or in-person at our offices at UCLA. As such, we require that participants live within driving distance to UCLA in order to participate in the in-person assessments, including providing a blood sample. You do need to reside in the US for the duration of the study (i.e., twelve months).
- Can I travel while I am enrolled in the study?
- You can travel inside and outside of the US while enrolled in the study, but you are still required to complete daily assessments and use the devices daily in order to receive compensation, which includes having access to Wi-Fi and being able to meet the charging requirements.
- If you are traveling in a location that does not have Wi-Fi or enable you to meet daily charging requirements, this may affect compensation earned for that quarter.
- If you are traveling for an extended period of time and unable to take the Beddit sleep monitor with you, you can notify the study team who will adjust for this gap in Beddit data. However, missing survey or watch data due to travel will not be adjusted.
- Can I enroll in other Research app studies?
There is no restriction against enrolling in other studies available through the Research app, so long as it does not affect your participation in this study, and you complete the required assessments as part of this study.
- Can I participate if I know someone, live with someone, or am related to someone who is enrolled in this study?
At this time we have no restrictions against that, but both individuals need to be eligible to participate in the study. Eligibility is determined by completing our screening and eligibility questions online.
- I’m concerned about participating in a study because of COVID-19, how will you conduct assessment visits?
Research assessments will be done through a secure video conference or in-person with safety procedures in place. Participants who visit UCLA for in-person assessments are required to provide valid proof of up-to-date COVID-19 vaccination and photo identification and complete a symptom screening on the day of the visit to ensure they do not have any symptoms in the last 14 days.
- If you send me study devices, is it safe for me to receive these at my home? What steps are taken to ensure the supplies are clean before sending to me?
- Study supplies have been quarantined for at least 72 hours before packaging into study kits, and study kits are prepared by a staff member who is wearing gloves and a face mask. We recommend that you maintain good personal hygiene and safe handling of the kit equipment as described below:
- Avoid touching your face when handling or transferring the package and when removing packaging materials and kit equipment.
- Disinfect kit equipment using 70 percent isopropyl alcohol wipe or Clorox Disinfecting Wipes. Refer to the manufacturer’s recommended safety precautions for handling disinfectant (e.g. Safety Data Sheet).
- Limit contact of disinfected kit equipment to clean, disinfected surfaces if possible.
- Wash hands with soap and water for 20 seconds when you are finished disinfecting.
- For additional concerns, please refer to CDC Guidelines for safe handling of packages.
- What information will be collected using my phone?
Once you have signed the study consent form and enrolled in the study, we will help you install an app on your iPhone (Apple Research app), which uses sensors embedded on your iPhone to record information about:
- Personal health (via Apple Health App which gathers health data from the iPhone, Apple Watch, and apps) such as: demographic information, medical records, health history, and workouts. Additionally, blood pressure and sleep information will be obtained if they are recorded in the Health app.
- Device and application data, such as number of steps taken, distance walked, location, phone usage, keyboard metrics (such as typing speed), survey data,
and other biosensor (accelerometer, gyroscope, speech metrics (such as speech rate and pitch) and face metrics (such as brow raises and eye blinks) data.
- The provided Apple Watch paired with the iPhone will record health metrics such as calories burned, minutes spent exercising, and heart rate, which will be stored in the Apple Health app.
- We will also provide a Beddit sleep monitor and will help you install the Beddit app on your iPhone. The Bedditmonitor will transfer data to the app installed on your iPhone so we can measure your sleep.
Again, the data described above will only be collected if you choose to sign the study consent form, enroll in the study, and install the Apple Research app. Ifyou are notcomfortable sharingthis information you can choose not to participate, and if you change your mind you can withdraw from this study at any time.
- How do I withdraw from this study?
- Your decision to participate in this study is voluntary.You can choose not to participate or stop participating in the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care.
- You can withdraw from this study by contacting the Study Staff and/or the Principal Investigator,andby withdrawing from the study within the Apple Research app on your iPhone. Withdrawing from astudy doesn’t delete any previously gathered data, but the app stops collecting any new data. Deleting the Apple Research app does not withdraw you from this study.
- What is the Apple Research app?
The Apple Research app allows you to find, enroll, and participate in Apple research studies using your iPhone, including allowing you to share certain information collected by your iOS, watchOS, and other devices. Any information collected or accessed by the Apple Research app is stored in encrypted form if you have a passcode on your iOS device. The Apple Research app can be used to understand the goals of the study, see the types of study data collected, and fill out surveys that are part of your participation in the study.
- Do I have to have my own iPhone to participate in the study?
UCLA Health System patients and UCLA Students must own an iPhone 7 or later with iOS 15 or later. However, eligible matriculating UCLA students who do not own an iPhone may be able to receive an iPhone XS Max for use for the duration of the study. Students who receive an iPhone on loan after otherwise being determined to be eligible to participate in the study will be responsible for transferring their own SIM card into this unlocked phone and maintaining the data plan for the duration of the study, and will be required to return the device at the end of the study. This option is only available for eligible matriculating UCLA students.
- Can I use a friend or family member’s iPhone to participate?
No, you can only use your own iPhone with your own iCloud account. This is to ensure data integrity and confidentiality.
- Can I participate if I share an iCloud account with others?
If you share an iCloud account with others, you should sign out of the iCloud account on devices that are not used exclusively by you. Or, you can create your own iCloud account to use on the devices that are used exclusively by you.
- Can I participate in the study if I have family sharing setup for my iCloud account?
Yes, if you have family sharing setup for your iCloud account, you can still participate in the study.
- Can I upgrade or downgrade my iPhone during the study?
Yes. If you change your iPhone during the study, we ask that you perform an iCloud back-up before switching, and restore from the iCloud back-up on the new phone in order to maintain enrollment in the study. There are additional steps to ensure transfer of the Research app and study enrollment, so please contact the study team before changing iPhones during the study.
- Do I need an Apple Watch to participate in this study?
No, an Apple Watch is not required to participate in this study, but will be provided for use throughout the duration of the study.
- I already have an Apple Watch. Can I still use it during the study? Do I need to unpair with my phone?
You cannot use your personal Apple Watch for study participation. We will ask you to unpair your existing device from your iPhone before you complete enrollment as part of your first assessment session to ensure that you only use the study device for the study. You can retain health data from your current Apple Watch by enabling iCloud sync for the Health app in Settings on iPhone. If you chose to no longer use the study-provided Apple Watch and unpair after the study, your data will still be accessible, for example, in Health app.
- Do I have to wear the Apple Watch on a specific wrist?
You can choose which wrist to wear the device on, but it is important to wear the Apple Watch on the wrist chosen during set-up. If you change position after set-up, please update in Apple Watch app.
- Can I use a different Apple Watch band than the one provided by the study?
Yes, you can use a different band so long as it continues to be worn snug on your wrist. If you find that sleeping with the provided Apple Watch Sport Band is uncomfortable while sleeping, we encourage you to purchase an alternative watch band.
- What happens if the provided Apple Watch is damaged?
If the study-provided Apple Watch is cracked or damaged during the course of the study, you will be instructed to contact Apple Care. You may be required to pay a fee to replace the damaged device.
- What are the Apple Watch wear requirements?
You will be asked to wear your Apple Watch for at least 20 hours each day, which includes during the day and overnight while sleeping. You may need to charge your Apple Watch twice (at least partially) during the day to meet the 20-hour requirement.
- What are the daily charging requirements?
- In order to support data collection, you will be asked to meet daily charging requirements, which includes charging your Apple Watch and iPhone together for at least two hours each day, while the devices are connected via Bluetooth and are connected to the same Wi-Fi. You do not have to charge during the same two hours each day.
- You will also be asked to charge your iPhone next to your Beddit while sleeping on the Beddit and while wearing the Apple Watch.
- We will provide a charging hub to facilitate charging requirements.
- What is a Beddit sleep monitor?
The Beddit sleep monitor is a thin, soft, and flat sensor strip that you place in between your mattress and fitted bedsheet in order to measure sleep quality. It is synced to an app on your iPhone, and must be kept plugged in during use. The Beddit app needs to be left running in the background, but it does not impact your phone’s battery life.
- What do I need to do in order to prepare for the first assessment session.
- You will need sufficient time to set-up the study devices and prepare for the first assessment session once you have received your Study Kit. The following steps are required before your scheduled intake assessment:
- Confirm you are on the latest iOS version
- Confirm that you can download apps to your iPhone, which may require having your Apple ID username and password available if needed
- If you own your own Apple Watch, unpair it from your iPhone
- Pair the Study provided Apple Watch to your iPhone
- Confirm your Apple Watch is on the latest watchOS version. If an update is needed, this requires that Apple Watch be placed on the charger and may take at least an hour to complete
- Pair and set-up the Beddit sleep monitor, which includes downloading the Beddit app from the App Store and setting the Beddit strip up on your bed
- Complete a series of self-report surveys which are sent to you by email, and take approximately 45 minutes to complete
- Prepare your space to ensure you are in a private location, where you can access a tablet or laptop in order to speak with the study team member via Zoom, have access to your Apple Watch and iPhone, and have access to stable Wi-Fi for the duration of the assessment
- You must have access to a stable Wi-Fi connection during your intake assessment, and it is strongly recommended to have access to a secondary device (tablet or laptop) in addition to your iPhone for the assessment.
- If you have not completed these tasks prior to the intake assessment, the study team will have to reschedule your session, and if unable to reschedule within the required time period, you will be unable to continue in the study.
- How is my study data kept confidential?
- The study data that is collected from or about you as part of the study (including any information that can directly identify you, such as your name and address) will be held confidential by the UCLA Study Staff at the study site in a secure database or locked location. Access will be limited to those members of Study Staff who need access in order to administer and conduct the study and they will be required to complete training about requirements to protect your privacy.
- The Sponsor will hold the Coded Study Data, including video recordings taken during the intake visit and through the video journal in the Research App, in a secure database. Access will be limited to those who need access in order to conduct analysis. All Coded Study Data will also be treated by the Sponsor in accordance with this consent form and its privacy policy (https://www.apple.com/legal/privacy/apple-health-studies/en-ww/).
- How much money can I earn from this study?
- You can earn up to $1070 for completing all of the study assessments, which includes completing daily tasks, wearing the Apple Watch for at least 20 hours daily (including overnight while sleeping), and meeting daily charging requirements. You will receive $60 for completing each of the four assessment sessions (whether remote or in-person). The total amount of compensation tied to rate of completion of the assessments per quarter.
- If you complete enough assessments over the study to reach Base tier each quarter and complete the assessment sessions, you may be able to keep the Apple Watch and Beddit. If you do not complete enough assessments to be eligible to keep the study devices, Study Staff will contact you until the devices are returned.
- If you agree to provide hair samples, you can additionally receive up to $60. You will receive $15 for each hair sample.
- You will receive a Visa debit card that can be filled by research staff to transfer payment. The Visa debit card will be mailed to you once the intake assessment is completed, and will arrive in 7-10 days. Once you have confirmed receipt of the card, compensation for the amount earned after the intake assessment will be loaded onto the card and will be available immediately. Compensation will be issued to this same card at quarterly intervals throughout the study. Final compensation will be loaded one week after the exit session once you have completed an online form to confirm withdrawal from the study in the Research app. You are required to complete enough assessments to reach at least the Base tier in order to receive any additional compensation after the initial intake compensation and remain enrolled until the end of a given quarter in order to receive compensation for that quarter. Compensation for remote tasks completed in a given quarter will not be provided if you withdraw from the study before the end of a given quarter.
- Who can I contact if I have questions or concerns about the study?
You can contact study staff at 310-339-9053 or digitalhealth@mednet.ucla.edu