Home2021-08-02T08:16:28-07:00

Make an impact, wherever you are.

Celiac research that works with your lifestyle—the virtual study.

You or Your Child Must Be

12 years or older*

Diagnosed with celiac disease 1+ years

On a gluten-free diet for past 6+ months

Experiencing celiac disease symptoms

Living in the U.S.

* Parental permission for adolescents 12-17 required.

About

The goal of this study is to better understand the symptoms and impacts of celiac disease. There are no blood draws, gluten challenges, medications, or doctor visits required. Complete daily questionnaires about your symptoms and life with celiac disease for 3 months—all from an online app! Compensation available.

What to expect with participation in this study?

Participants with celiac disease will complete daily multiple-choice questionnaires for 3 months using an online app on a mobile device. Questionnaires can be completed at any time during the day. Compensation is available for this study based on survey completion. Payments are made to qualified participants biweekly throughout the 3 months of participation.

The approximate time to complete each questionnaire is listed below:

Day 1: Baseline questionnaires will take about 1.5 hours.

After Day 1: Daily questionnaires will take about 5-10 minutes per day.

Once per Week: Weekly questionnaires will take an additional 4-5 minutes per week.

Once per Month: Monthly questionnaires will take an additional 30-45 minutes to complete.

FAQ

What is the purpose of this study?2021-07-26T19:10:02-07:00

The purpose of this study is to learn more about the symptoms that people with celiac disease experience and how these symptoms affect different aspects of an individual’s life, including social, emotional, and economic aspects and overall quality of life.

The results from this study will help to inform outcome measures in future clinical trials for investigational treatments of celiac disease.

Who is sponsoring this study?2022-02-23T09:14:43-08:00

This study is sponsored by Takeda, a pharmaceutical company developing potential new medicines for patients with various health conditions, including celiac disease.

This study is being conducted by Analysis Group, Inc. (AG) on behalf of the Sponsor Takeda. AG is a research organization with headquarters in the United States.

 

How do I participate in the study?2022-02-23T09:17:45-08:00

To determine if you qualify for the study, you will be asked to create an iQualifyCeliac account and answer a few questions about your diagnosis.

If you qualify, you and/or your child will be invited to download an app on your smartphone and answer daily questionnaires. The app was developed and is administered by uMotif (See Privacy Policy & Terms of Use). uMotif is a company that develops modern data capture platforms for research.

My child and I have celiac disease. Can we both participate? Do we participate together or separately?2022-02-23T09:21:16-08:00

If you and your child (12-17 years old) are eligible for this study, you will both be invited to participate and, if you both choose to participate, you will each separately complete the questionnaires. The steps are as follows:

Step 1: As the parent, you will first create an account for yourself in iQualifyCeliac to find out if you and/or your child qualify to participate.

Step 2: Next, you will create a profile for yourself and a profile for your child, both of which will be under your account.

Step 3: You will complete separate screening surveys, one for yourself and one for the child you create a profile for, to determine whether you and/or your child are eligible to participate in the study.

If you qualify to participate in the study, an email will be sent to your email address with a unique invitation code to join the study and instructions to download the uMotif app on your mobile device. You will be asked to provide your consent to participate in the study. From then on, you will complete the study questionnaires. 

If your child qualifies to participate in the study, an email will be sent to their email address with a unique invitation code to join the study and instructions to download the uMotif app on their mobile device. In the uMotif app, you will be asked to provide consent for your child to participate in the study, and your child will be asked to provide their assent. From then on, your child can complete the study questionnaires on their own.  

We recommend you and your child use separate smartphones, if possible. However, multiple people may participate on the same device by logging in and out of their individual accounts in the uMotif app. Please note that if you share a device, study push notifications from the app will only apply to the most recent user. 

How does participation work if my child has celiac disease, but I don’t?2022-02-23T09:22:24-08:00

As the parent of a child aged 12 to 17, you will first create an account for yourself in iQualifyCeliac to find out if your child qualifies for the study. You will enter your own information first, and then you will create a profile for your child. You will complete the screening survey for your child under their profile.

If your child qualifies to participate in the study, an email will be sent to their email address with a unique invitation code to join the study and instructions to download the uMotif app on their mobile device. In the uMotif app, you will be asked to provide consent for your child to participate in the study and your child will be asked to provide their assent. From then on, your child can complete the study questionnaires on their own.

When registering for my child, do I provide my child’s phone number and email address for study communications, or mine?2022-03-04T15:08:22-08:00

As the parent of a child aged 12-17, you will first create an account in iQualifyCeliac with your phone number and email address. Then, you will create a profile for your child with their name and email address. You will not be asked to provide your child’s phone number.

Will my child be contacted directly by phone or email?2022-03-04T15:08:52-08:00

Provided you consent for your child to participate, the only direct communications with your child (aged 12-17) will be automated study-related emails, and your child may also receive push notifications from the uMotif app if they choose. These messages sent to their email address include the following:

  1. After the screening questionnaire, before enrolling in the study: a notification about whether they qualify to participate; and, if qualified, 2 reminders to download the app on their mobile device to enroll in the study. (Note: Once in the app, you will need to provide your consent before they are able to advance to the study questionnaires.)
  2. Once enrolled in the study: progress updates, reminders to complete questionnaires, and payment milestone updates.

Any study-related phone calls or text messages will be to your phone number, not your child’s. We will not ask you to provide your child’s phone number, and we will never contact your child by phone. We treat children’s information with extra care to ensure that they receive additional protection and safety. We only collect personal data about children with the consent of a parent or guardian for the provision of services such as research activities. However, we do not otherwise knowingly solicit data from, or market to, children.

What if my child is about to turn 18?2022-03-04T13:09:30-08:00

If your child will be turning 18 within the next 2 weeks, we ask that they wait until their 18th birthday to create an iQualifyCeliac account and complete the screening questionnaire. If they qualify to participate, they will be invited to join the study as an adult.

If your child will not be turning 18 within the next 2 weeks, you can first create an account for yourself in iQualifyCeliac to find out if your child qualifies for the study. You will be asked to enter your own information, and then you will be asked to create a profile for your child. You will then be able to complete the screening survey for your child under their profile. If they qualify to participate, they will be invited to join the study as an adolescent with your consent.

 If your child turns 18 during the study (3 months), they will need to provide their informed consent to continue to participate in the study. They will receive an email with instructions on their 18th birthday.

Why do I need to provide my contact information?2022-03-04T13:23:45-08:00

We ask you to provide your contact information during registration for the following reasons:

Before enrolling in the study:

  1. To verify you are not a robot and that your account is not a duplicate. Each qualified person is only allowed to participate once and must use a valid email address and phone number.
  2. To notify you of whether you qualify to participate in this study.
  3. If you qualify, to remind you to download the mobile app and enroll in the study, if you haven’t already.

Once enrolled in the study:

  1. To set up your account to receive your biweekly electronic payments for completing questionnaires.
  2. To send progress updates, reminders to complete questionnaires, and important notifications about your payment milestones and participation in the study.
How do I opt out of study communications?2022-03-04T13:23:14-08:00

You may opt out of study text messages by replying “stop” to any text message, or by updating your iQualifyCeliac account preferences:

  1. Log in to your iQualifyCeliac account
  2. Click the dropdown in the upper right corner
  3. Select Profile
  4. Click Edit Profile
  5. Uncheck the box next to “I agree to receive study text messages if I or my minor child(ren) enroll in a study.”
  6. Click Update Profile

Study reminders via phone call and email are required for participation. To stop receiving these reminders, please email virtualstudy@celiac.org to withdraw from the study.

Where is this study located?2022-03-04T13:17:43-08:00

This study is virtual. Your and/or your child’s participation will take place entirely online, using the uMotif app on your smartphone.

You and/or your child must currently live in the United States to participate in this study.

Does it matter where I live?2022-03-04T13:15:39-08:00

Yes. You and/or your child must be residents of the United States to participate in this study.

Am I allowed to change my mind about participating once I am enrolled in the study?2022-03-04T13:14:12-08:00

Yes. Your participation is completely voluntary. If at any point you or your child decide you no longer wish to participate, you can leave the study.

To withdraw from the study, please email virtualstudy@celiac.org.

Will I have to consume gluten in this study?2022-03-04T13:26:43-08:00

No. You and/or your child will be asked to continue your usual gluten-free diet for the entire study.

Does it matter if I use my phone or computer to participate?2022-03-04T13:19:32-08:00

The uMotif app—where you and/or your child will complete all study questionnaires—must be downloaded and accessed on a smartphone with internet connection. The study questionnaires cannot be completed on a laptop or desktop computer.

Are there any medications or medical procedures involved in this study?2022-03-04T13:12:29-08:00

No. There are no blood draws, medications, medical procedures, or visits with a healthcare professional that are required during this study.

Must questionnaires be completed at the same time each day?2022-03-04T13:16:13-08:00

We recommend that you and/or your child complete the questionnaires at about the same time each day; however, the questionnaires can be completed at any time during the day.

Are questionnaire responses confidential?2022-03-04T13:14:37-08:00

All information related to participation in the study will remain confidential and no answers will be linked to your or your child’s name. Additional details about data security and usage will be provided in the app prior to enrolling in the study.

How soon after qualifying to participate must I begin the study?2022-03-04T13:13:45-08:00

If you or your child qualifies to participate in the study, an email will be sent to your or your child’s email address with a unique invitation code to join the study and instructions to download the uMotif app on your mobile device.

You may enroll in the study to begin participating any time after receiving the invitation code, until the study becomes full.

If you would like to participate, we encourage you to enroll at your earliest convenience, as there are a limited number of available slots in the study. However, please take the following into consideration as you decide when to enroll:

  • Within the first few days of enrolling in the study, participants will be required to complete baseline questionnaires which will take about 1.5 hours over the course of those days. If a participant is unable to complete all of these baseline questionnaires within the specified time frame, they will not be eligible to receive payment or to continue participating in the study.
  • After qualifying to participate, if you and/or your child does not enroll before the study becomes full, your unique invitation code will expire, and you will no longer be able to enroll in the study.
Will I be compensated for my time?2022-03-04T13:25:38-08:00

Yes. Compensation is available for this study. Payment is made to each participant biweekly throughout the 3 months of participation based upon survey completion. Details for meeting each payment milestone can be found on the Payment Information Page.

How will I be compensated?2022-03-04T13:20:02-08:00

To receive payment, you will be issued a virtual ClinCard from Greenphire, a clinical trial financial management company that is supporting the payment process. A virtual ClinCard is a digital representation of a debit card that your funds are loaded onto and can be used at your discretion or transferred to your bank account. If your child qualifies for payment, you will be issued a virtual ClinCard on their behalf.

I have additional questions, who can I contact?2022-03-04T13:13:13-08:00

For eligibility/screening or payment questions, or to withdraw from the study, please contact virtualstudy@celiac.org.

For other study questions, please contact celiacsymptoms@analysisgroup.com.

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