At-Home FAQ - RECONNECT Fragile X Study

New AT-HOME Option to Participate

As an option to help lessen potential barriers for families who live far from a Fragile X clinical study site or find it too challenging to go to a site, the study visits for RECONNECT can now be conducted AT HOME through a combination of at-home and virtual visits.

Is this option right for my family?

If you have a desire for your child (age 3 through 22 years old) to participate in a clinical trial, but going to a study site may be too much of a barrier, this option may be for you.

Eligible participants living anywhere in the USA other than Alaska, Hawaii, and Washington DC may participate.

How do I find out if my child is eligible to participate?

Please go to fragilexhelp.com to fill out a form to be contacted or call 833-680-1155

How will I know if my child qualifies upon assessment?

You will be asked questions about your child and his/her symptoms of Fragile X. If the information suggests your child is eligible, the information will be provided to the study doctor and staff to follow up with you to schedule a more detailed assessment to confirm your child qualifies.

Will this impact the care of my child by their current doctor?

No. Your child will continue to receive care from their doctor as they currently do. The study visits are focused on conducting assessments for the study. The study doctor may share relevant information with your child’s current doctor.

Is this at-home option available if my child is already participating in RECONNECT?

No, your child will continue to participate at their current study site. As a reminder, current participants and any newly enrolled child who participates at a clinic study site have a combination of 4 in-clinic (office) visits and 4 virtual visits.

Will I have the same contact throughout the study as I would if taking my child to a Fragile X clinical study site for visits?

Yes, we will try our best to keep the same study contacts throughout the study. However, similar to any study site, a new study contact may be used for coverage in case of sickness or out of office time.

What is the difference between “at-home” and “virtual” visits?

During an “at-home” visit, a study nurse will visit your home to conduct study assessments along with having some study staff who will join virtually on a call/video communication. During ‘virtual’ visits, all assessments will be done virtually through a live video communication from your home.

Are the study procedures the same for the at-home option and the in-clinic option?

Yes, the study procedures and assessments are the same, including obtaining a blood sample and an electrocardiogram at the first visit and the last visit.

Will I receive the study medication at home?

Yes, the study medication will be shipped to your home.

How will the medication be shipped and how does it need to be stored?

The study medication will be shipped by a courier service in a temperature-controlled container. The study medication may be stored at room temperature in your home.

Will I be trained to administer the medication to my child?

Yes, the study staff will provide training to administer the study medication.

How will I report results since all will be done in my home?

The information collected for the study will be collected on an iPad that is used specifically for entering information for the study.

What if I have questions about my child’s response to medication in between at home or virtual visits?

Please reach out to your Science 37 Clinical Research Coordinator via phone, email, or text message. They will be happy to answer any questions or concerns and will be sure to communicate them with the study doctor. If needed, a virtual visit or phone call can be set up with the study doctor as well.

Who is Science 37?

Science 37 is the name of the organization providing this virtual trial option. Dr. David Kudrow is the lead investigator for Science 37 for RECONNECT and he is joined by other doctors, nurses and staff to conduct the at-home and virtual visits for the study. Science 37 has conducted many at-home studies, including studies in children, adolescents, and young adults.