How BRACE uses the Trial Symptom Tracker app
The Trial Symptom Tracker app is used to capture data to find out whether BCG vaccination protects against COVID-19 or reduces severity of COVID-19 in healthcare workers in the BRACE trial.
We are looking at what symptoms participants experience when they become unwell, and how the severity of these symptoms impacts their lives and our healthcare workforce. This includes:
- Type of symptoms
- Number of days experiencing symptoms
- How many times a participant is unwell (i.e. how many ‘episodes of illness’ a participant has)
- COVID-19 test results each time respiratory symptoms are experienced
- Number of missed work days due to illness
- Number of hospital admissions
Each week participants do a weekly symptom check-in via their app. For any day of symptoms reported they are then asked if they’ve been too ill to work, confined to bed, or tested for COVID-19. At the end of each ‘episode of illness’, the Trial Symptom Tracker app asks a series of questions about health service use and the number of missed work days over this period.
How did you create the Trial Symptom Tracker app?
The Trial Symptom Tracker app is a collaboration between MCRI and our digital patient engagement platform partner WeGuide. WeGuide is a product from the digital health company Curve Tomorrow, which has been MCRI’s digital technology partner for over 7 years. MCRI is currently using the WeGuide application to drive the data collection for the BRACE trial and a number of other studies.
For more detailed information about how the app was developed for the BRACE trial check out the FAQ section below.
If you have any feedback on the app please send it to MCRI: firstname.lastname@example.org
If you have any specific questions regarding the digital engagement platform WeGuide please email: email@example.com
New features in v1.1.12
On September 14th 2020, the Trial Symptom Tracker app v1.1.12 was released with brand new features. The new features on the app include:
• A clear indication on the home screen when data input is required
• Changing colours on the calendar when daily symptoms are logged
• Addition of a My Trial Symptom Journal
For more detailed information about these brand new features check out the FAQ section below.
Trial Symptom Tracker FAQs
The calendar and the colour indication
The first time you launch the app, you will see a calendar showing up on the screen. All the past dates are in purple and all the future dates are in grey.
When you start doing symptom check-ins, according to the entry and whether you have selected any symptoms, the calendar date will then show up in different colours:
Purple: You haven’t done any symptom logging on this date, and a daily check-in is available if you’d like to report symptoms
Blue: You were not in an illness episode on this date, and you have done the symptom check-in on the date. You’ve reported mild of no symptoms, there is no further action required by you
Red: Since you have previously entered symptom information, we suspect you might be in an illness episode on this date. The date shows up in red to remind you to do the symptom check-in on the date.
Green: Since you have previously entered symptom information, we suspect you might be in an illness episode on this date. The date shows up in green confirming you have done the symptom check-in on the date.
My Trial Symptom Journal
On the top right of the main screen, there is a ‘journal’ icon. You can see the data you have previously entered by clicking on it. But the data cannot be editable.
You can route back to the home screen by clicking on the ‘back’ button on the top left.
When Nigel Curtis (head of infectious diseases at RCH) was first approached to run a clinical trial by WHO back at the start of the year, he needed a more efficient way to collect data from the thousands of participants. He was introduced to WeGuide, and the teams worked together around the clock to design, scope, test and implement the Trial Symptom Tracker app within 3 weeks, to get the BRACE COVID-19 trial up and running. Something that would normally take 3-6 months.
The WeGuide platform, is purpose built for digital engagement and data capture within healthcare, and complies with all relevant security standards and regulations, including GDPR, HIPAA, Australian Signals Directorate (ASD), OWASP Healthcare guidelines, Australian Privacy Act, ISO’s and SOC2.
To determine the effect of the BCG vaccine, it is critical all participants get a COVID-19 test when showing any symptom of respiratory disease. Even if you do not suspect that you have been exposed to COVID-19, you must still get a COVID-19 test. Otherwise, our trial will have missing data, which undermines the outcomes of the study. If you are currently participating in the BRACE trial please contact your study coordinator if you have any concerns.
The outcomes of the study also rely on careful reporting of the severity of illness. For example, whether you have been hospitalised or so sick that you have been unable to work or go about your normal activities. Please ensure that you report how many days you have been too unwell to go to work or do normal activities.
I’ve been entering data to my Trial Symptom Tracker app, and I am sure I have not forgotten, but I am still being contacted regarding missing information. What am I doing wrong?
Check that your device is connected to Wifi. The information you input into the App on your device will only synchronise with the database when Wifi is enabled and connected.
Once you submit your responses via the app you can’t change them. In this case, contact us via the Study Info icon which can be found on the bottom of the screen when you open your Trial Symptom Tracker app. Alternatively, email us at firstname.lastname@example.org
Your weekly check-in option will appear 7 days after your last entry indicating that you have no symptoms of illness to report. For example, if you enter data on a Monday, the weekly option will pop up the next Monday. Should you miss seeing that option it will still be available on Tuesday.
TIP: set your own weekly reminder on your phone
If you have previously entered symptom information, for example: fever, persistent/intermittent cough, shortness of breath/difficulty breathing or sore throat, you will need to continue doing this every day until you are well AND you have indicated your return to health by entering “None of the above”.
Check that the ‘receive notifications’ option is switched on in your device. Secondly, ensure that your version of the Symptom Tracker is always current by enabling the automatic updates function in your smartphone or iPad.
When see no activity being uploaded to database for 2 or 3 weeks, we will send an SMS message to remind you to use it. If we still don’t see any activity we will give you a call to make sure you’re okay.
Yes please. Every time you are unwell, please enter your symptoms into your Trial Symptom Tracker in a daily symptom check entry.
Please only enter symptoms when you are feeling unwell. If you are prone to getting headaches when stressed or tired, you don’t need to log these here. You also don’t need to log symptoms due to your hay fever.
You are certainly welcome to, but you don’t have to! You only need to log symptoms daily if you are unwell, otherwise you just need to do a weekly symptom check-in.
The app will remind you to get tested each day your report trigger symptoms, regardless of whether you’ve already reported being tested.
Let us know via the Study Info tab in your app. Pressing the Contact Us button will bring up a field for you to enter this information. Please include the date you were tested and the test result.
I was tested for COVID-19 when I had a runny/blocked nose, etc ‘other’ symptoms. Where do I report the result of my COVID-19 test?
Let us know via the Study Info tab in your app. Pressing the Contact Us button will bring up a field for you to enter this information. Please include the date you were tested, the test result and the symptoms you experienced prompting this test.
When you downloaded and logged into the app for the first time you would have been asked to set a time for reminders and notifications. Once this is set you are unable to change the time via the app. If you have an Apple device you can work around this by un-installing and reinstalling the app. Contact the study team if you need your login details again.
• You complete app check-ins reporting any COVID-19 symptoms of fever, cough, sore throat, or difficulty breathing, and then stop completing check-ins, and don’t report that the symptoms have resolved
• You complete app check-ins reporting you have had fever, cough, sore throat, or difficulty breathing & you now have no symptoms, but the end of illness questions haven’t been competed in the app
• You complete your daily symptom check-ins retrospectively, indicating that you’ve had an episode of illness that has resolved. In this instance, the app doesn’t ask the end of illness questions, so we need to follow this up with you.
• If you report being tested for COVID-19, but we don’t have the result (eg. when you complete the end of illness questions, & have reported you’re still waiting for the result)
• If you report that you’ve been unwell and confined to bed for 3 or more days
• You report being admitted to hospital