The information on this page will be important to participants enrolled in PRE-EMPT.
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Return here for details about your participation in PRE-EMPT.
mHealth: What to Expect from mHealth in PREEMPT
As a PRE-EMPT participant, you’ll be supported throughout the study with helpful messages and surveys sent directly to your phone. Here’s how it works:
Setting up your Fitbit device
Step 1: Download the Fitbit app
- Go to the App Store (iPhone) or Google Play Store (Android).
- Search for “Fitbit” and download the free app.
Step 2: Create a Google/Fitbit account
- Open the app and follow the prompts to create an account. If you already have a Fitbit account, you can use it for the study. If you don’t have a Fitbit account, you will need to use or create a Google account for Fitbit login.
- If you already have a personal Google (Gmail) account, you can use it to set up your Fitbit account. If you have a personal Gmail account but do not wish to use it for the study, see below
- You should have received an email with the subject “PRE-EMPT: Google/Fitbit account credentials”. Search your email for this message, including in Spam/Junk folders. We have provided you with a username and password for a Google account to be used in the study.
- If you choose to use the study-provided Google account, please note this account will only be active during the study, and will deactivate when the study is completed. Please use a personal email address for all study communications.
Step 3: Pair your Fitbit device
- Make sure Bluetooth is turned on.
- In the Fitbit app, tap your profile icon and choose “Set Up a Device.”
- Select Fitbit Charge 6 (or the model provided) and follow the on-screen instructions.
- Keep your Fitbit close to your phone during setup.
Step 4: Sync Your Fitbit
- Your Fitbit will automatically sync when the app is open and Bluetooth is on.
- You can also manually sync by opening the app and pulling down on the screen.
Step 5: Link your Fitbit account with Fitabase
- We will be using a platform called Fitabase to store your Fitbit data during the study. To begin the lifestyle coaching mHealth intervention, you will need to grant Fitabase access to your Fitbit data
- You will receive a text message and email with a personalized link (from app.fitabase.com) that will walk you through the steps for linking your Fitbit account with Fitabase
- When linkage is complete, you will see a screen with a green box that says ‘Connected!’ You will also receive a text message from the mHealth phone number confirming that Fitabase linkage was successful
- If you do not receive a confirmation text message, please reach out to your coordinator for assistance
Step 6: Start receiving lifestyle coaching messages
- In the next 2 weeks, you’ll begin receiving personalized text messages based on your Fitbit data.
- These messages will support your health goals and help guide your participation in the study.
Surveys
You will be asked questions about your adherence to the study drug by text message at 2 weeks, 1 month, 2 months, 4 months, 6 months, 9 months, 15 months, 18 months, 21 months. You will be asked by phone call with a coordinator at 3 months, 12 months, and 24 months.
“How often over the last 7 days did you take your colchicine or colchicine placebo medication or your rosuvastatin or rosuvastatin placebo medication?”
The following questions will be asked about changes in health status, sleep, contact information, and food, by text or in a phone call at 3 months, 6 months, 12 months, 18 months, and 24 months.
We will ask you:
- Have you had any new medical issues, such as new diagnosis of diabetes, new increase in liver test results, newly decreased kidney function, new anemia, new muscle pain or weakness, new numbness or tingling in extremities, nausea, vomiting or diarrhea, or infection requiring medical attention?
- Have you have been hospitalized or had any new cardiac tests, any cardiac procedures (PCI/stent, CABG, or diagnostic catheterization) or cardiac events (heart attack, stroke)?
- On average, how many hours of sleep do you get per night?
- Do you need to update your contact information or mailing address?
- Eating habits
Reporting a Problem
If you're participating in the PREEMPT study and experience a problem—whether it's with your Fitbit device, the text messages, or anything related to your health or study experience—here’s what to do:
What to expect at the 24-month visit
Your final study visit is an important milestone! Here’s what will happen: