Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial (U-REAACT)
Spina Bifida, Kidney Transplant
About this trial
This is an interventional supportive care trial for Spina Bifida focused on measuring Spina Bifida, Kidney Transplant
Eligibility Criteria
Inclusion Criteria:
- Males or females age 12-24 years.
- Kidney Transplant subjects must be greater than 3 months post-transplant.
- Spina Bifida subjects must be able to perform Clean Intermittent Catheterization (CIC) as part of their treatment.
- Able to speak and read in English.
- Willing and able to provide informed assent or consent.
- Parental/guardian permission (informed consent) if appropriate.
Exclusion Criteria:
- Unwilling to participate.
- Unable to speak or read in English.
- Unable to provide informed assent or consent.
- Severe cognitive impairment, as reported by treating team in recruiting clinic.
- On dialysis.
- Acquired post-transplant lymphoproliferative disease less than one year prior to enrollment
- Less than 3 months post-transplant.
- Unable to perform CIC.
- Prescribed Immunosuppressive medications once per day.
- Provider recommendations of CIC once per day
Sites / Locations
- Children's Healthcare of Atlanta
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Boston Children's Hospital
- Children's Mercy Hospital
- The Children's Hospital of Philadelphia
- Seattle Children's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm 1 - No Feedback, Minimum Incentive
Arm 2 - Feedback, Maximum Incentive
Subjects will receive daily text message reminders and report real-time treatment adherence with photos. They will receive compensation to encourage real-time adherence reporting. Subjects will also be able to log into a personal dashboard with a visual display of their weekly adherence performance and educational resources related to their primary disease. Every month, participants will receive a text encouraging them to visit their personal dashboard. The dashboard is able to track usage of the modules by individual. Parents/legal guardians will have access to these same educational materials via their own portals. Additionally, to mitigate the minimal risk of this study, parents/legal guardians will be notified if their child is excessively non-adherent.
Subjects will receive daily text message reminders and report real-time treatment adherence with photos, and will have web access to the educational modules through their portal. Every month, participants will receive a text encouraging them to visit their portals. In contrast to Arm 1, they will receive their weekly performance results by text to their phone with tailored feedback. In Arm 2, subjects will receive a larger incentive if they perform their desired treatment behavior. Incentive notification will be texted to participants. Similarly to Arm 1, parents/legal guardians will have access to the same educational materials via their own WTH portals. Additionally, to mitigate the minimal risk of this study, parents/legal guardians will be notified if their child is excessively non-adherent.