Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

The overarching goal of this five-year, phase II, randomized clinical trial is to improve
poor long-term health outcomes in both adolescents and young adults (AYA) with either a
kidney transplant (KT) or spina bifida (SB), respectively. More specifically, this study will
focus on decreasing premature allograft loss in subjects with kidney transplant (KT) due to
medication nonadherence and kidney damage in subjects with SB due to urinary non-continence.
To achieve these goals, this study will implement a real-time feedback system, Way to Health
(WTH), that will provide education and support, increase awareness and incentivize positive
health behavior, in addition to standard of care. Further, this study will investigate the
mechanisms of behavior change by examining the role of financial incentives, positive
feedback and the relationship between the two. The study will compare two cohorts of KT and
SB subjects, which will undergo varied levels of financial incentives and positive feedback.
Data from KT and SB subjects will be analyzed jointly and separately. This innovative mobile
health (mhealth) strategy will improve our current measures of adherence and increase our
understanding of factors that influence adherence for two AYA populations, KT and SB
subjects, respectively. The study will contribute novel insight to inform the design of
future interventions targeting persistence of behavior change and can be used in other
centers and for other chronic disease groups.

The study intervention will use the WTH web-based platform to support AYA with KT or SB as
they navigate their daily treatment burdens. This will be achieved via bi-directional text
messaging, including the sending of reminders and positive feedback by WTH and the messaging
of pictures of medication or catheter in hand at time of treatment by the participant. This
intervention will assess sustainability of this novel bi-directional messaging system and the
impact of providing education and support, increasing awareness and incentivizing positive
health behavior in real-time.

Inclusion Criteria:

1. Males or females age 12-24 years.

2. Kidney Transplant subjects must be greater than 6 months post-transplant.

3. Spina Bifida subjects must be able to perform Clean Intermittent Catheterization (CIC)
as part of their treatment.

4. Able to speak and read in English.

5. Willing and able to provide informed assent or consent.

6. Parental/guardian permission (informed consent) if appropriate.

Exclusion Criteria:

1. Unwilling to participate.

2. Unable to speak or read in English.

3. Unable to provide informed assent or consent.

4. Severe cognitive impairment, as reported by treating team in recruiting clinic.

5. On dialysis.

6. Acquired post-transplant lymphoproliferative disease less than one year prior to
enrollment

7. Less than 6 months post-transplant.

8. Unable to perform CIC.

9. Prescribed Immunosuppressive medications once per day.

10. Provider recommendations of CIC once per day