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T1DAL Study

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A A A

Thank you for your interest in T1DAL !

WHAT IS T1DAL?
T1DAL stands for Type 1 Diabetes Adolescents for healthier Lifestyles. T1DAL was designed to support teens in living their healthiest and happiest lives with type 1 diabetes.

WHAT WOULD I DO IF I SIGN UP?

T1DAL is a research study. The goal of T1DAL is to determine whether there are any health differences between teens who complete the T1DAL program and teens who do not. If your teen is eligible to participate in the study, they will be randomly assigned either to the T1DAL program or to Usual Care. This is done by a computer algorithm similar to rolling a dice. Neither you nor we (as the study team) have any say in which group your teen is assigned to.

The T1DAL program is a virtual, group-based program. Your teen would be invited to attend one 60-minute session per week for about 4 months and a few individual check-in calls with a trained study staff member. Parents/caregivers will be invited to attend 4 group sessions. All sessions will occur via Zoom, and group session timing is entirely dependent on the availability of our participants. Each session involves a combination of education on healthy living (e.g., managing diabetes, balanced eating, coping with stress, safe exercising), group discussions, and games. Each group will be made up of about 4-8 other teens who also have type 1 diabetes and are interested in learning how to make healthier choices.

Usual Care means that teens will NOT attend the T1DAL program, but rather continue to manage their diabetes as they normally would (e.g., attend routine endocrinology appointments). They will receive monthly newsletters from the study team, and they will be invited to an optional abbreviated T1DAL workshop after the study ends.

IS THERE ANYTHING ELSE INVOLVED?
All participants, regardless of randomized group, will complete 2 individual assessment appointments (~1 hour each). Each of these assessment appointments will occur virtually and involve both the teen and caregiver answering questions about themselves and their medical histories. Teens will also be asked to share their current height, weight, and percent time in target blood glucose range. Study staff can assist teens in determining these measurements.

WHY SHOULD I PARTICIPATE?

Research studies are important for us to definitively say whether the healthcare programs we create help teens with type 1 diabetes. If your teen is randomized to the T1DAL program, they may learn how to live healthier with type 1 diabetes and make new friends in the diabetes community. However, it's also possible that nothing will change.

There are minimal risks to participating. Teens do not have to answer any questions they do not feel comfortable answering. All participants are volunteers and can choose to quit at any time.

All participants (teens and parents/caregivers in the T1DAL and Usual Care groups) will be compensated for their time and effort. All teens have the opportunity to earn up to $175 throughout the study and parents/caregivers may earn up to $40.

ANYTHING ELSE I SHOULD KNOW?

Choosing to participate is up to you. The study is FREE to join and does not require any insurance.

If you and your teen are interested in joining this study, please answer the following questions to see if your teen might be eligible. Completing this questionnaire is NOT a commitment to join the study. If you are interested and potentially eligible, someone from our team will contact you to discuss the next steps.

Unless your teen is 18 or older, these questions must be filled out by the parent or caregiver.

Who is completing this form?

Teen

Parent/Caregiver

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Are you 18 or older?

Yes

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Please have a parent or caregiver complete this form. Thank you.

Completing this form does not make you a participant and is intended only to assess eligibility. The study is completely voluntary, and you or your teen can decide at any time not to participate. If you are eligible and decide to participate, a research staff member will review all of this information with you in a consent form during your first study appointment.

These questions will ask information about you, your teen, and your teen's health. This information is collected only to determine whether you and your teen meet the eligibility criteria for the study. Your answers to these questions will be kept in a password-protected, secure file only available to trained study staff. Once study recruitment is complete, all data will be deidentified and kept in a secure file. If you are not eligible, all identifiable information will be destroyed once study recruitment is complete.

Thank you for your interest in the T1DAL study! If you have any questions, please contact Dr. Jenny Warnick at 401-793-8757 or email us at t1dal@brownhealth.org.

Teen's FIRST name and LAST name:

* must provide value

Teen's phone number:

Teen's e-mail:

How do you prefer we contact you (teen)?

(One selection allowed per column)

1st Choice

2nd Choice

3rd Choice

4th Choice

Do not use this method

Only contact my parent/caregiver

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Phone

reset

Text

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No sensitive information, such as information about your health, will be included in text messages. Likewise, our responses should not include sensitive information. If you have sensitive information to share with the study, please call a study staff member.

We take your confidentiality seriously and will take steps to protect the information contained in the text messages to the degree permitted by the technology being used. Depending on the nature of the study, some of the following steps may be taken: encrypting the data during transmission, eliminating sensitive health care information from the texts, and storing all data gathered on secure servers.

However, we can make no guarantees about the secure transmission of texts you send to us, nor can our institutions guarantee security after you receive the text message from the study. For example, text messages that display on your phone screen may be seen by someone close by or by someone you have allowed to use their phone. Also, if you do not password protect your phone and it is lost or stolen, anyone who finds it might view the information in the texts. To try to lessen these risks, you should make sure your phone is password protected, only open and view messages where no one will be able to view the screen and delete messages as soon as possible after reading them. Additionally, when you trade in the phone, remember the SIM card (memory card used in cell phones) should be cleared.

Finally, it is also possible that the mobile phone company that transmits the text messages may keep copies of ALL your texts (those from the study, and your other texts) even after the study is ended. The study has no control over these companies and cannot make any guarantees about their conduct.

Would you (teen) still like to receive text messages?

* must provide value

Yes

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Parent/caregiver FIRST name and LAST name:

* must provide value

Parent/caregiver phone number:

* must provide value

Parent/caregiver phone type:

Mobile

Home

Work

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Parent/caregiver email:

* must provide value

How do you prefer we contact you/your caregiver?

1st Choice

2nd Choice

3rd Choice

Do not use this method

Phone

reset

Text

reset

No sensitive information, such as information about your teen's health, will be included in text messages. Likewise, our responses should not include sensitive information. If, as a parent/caregiver, you have sensitive information to share with the study, please call a study staff member.

We take your confidentiality seriously and will take steps to protect the information contained in the text messages to the degree permitted by the technology being used. Depending on the nature of the study, some of the following steps may be taken: encrypting the data during transmission, eliminating sensitive health care information from the texts, and storing all data gathered on secure servers.
However, we can make no guarantees about the secure transmission of texts you send to us, nor can our institutions guarantee security after you receive the text message from the study. For example, text messages that display on your phone screen may be seen by someone close by or by someone you have allowed to use their phone. Also, if you do not password protect your phone and it is lost or stolen, anyone who finds it might view the information in the texts. To try to lessen these risks, you should make sure your phone is password protected, only open and view messages where no one will be able to view the screen and delete messages as soon as possible after reading them. Additionally, when you trade in the phone, remember the SIM card (memory card used in cell phones) should be cleared.

Finally, it is also possible that the mobile phone company that transmits the text messages may keep copies of ALL your texts (those from the study, and your other texts) even after the study is ended. The study has no control over these companies and cannot make any guarantees about their conduct.

Would you still like to receive text messages?

* must provide value

Yes

reset

How did you hear about the TIDAL Study? (Check all that apply)

Mailed flyer

E-mail

At the endocrinology/doctor's office

Flyer

Camp newsletter

Social media

Referral

Word of mouth

Text message

Other

Breakthrough T1D

Please tell us how you heard about T1DAL.

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