Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial
Condition: Spina Bifida; Kidney Transplant
MeSH terms: Spinal Dysraphism
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of behavioral feedback plus
      economic incentives to promote treatment adherence among a large diverse population of
      adolescents and young adults (AYA) with kidney transplant (KT) or spina bifida (SB).
    

Detailed description: 
      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.
    

Intervention name(s): Behavioral Feedback and Economic Incentives: Arm 1; Behavioral Feedback and Economic Incentives: Arm 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The purpose of this study is to determine the effectiveness of behavioral feedback plus economic incentives to promote treatment adherence among a large diverse population of adolescents and young adults (AYA) with kidney transplants (KT) or spina bifida (SB). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.; The purpose of this study is to determine the effectiveness of behavioral feedback plus economic incentives to promote treatment adherence among a large diverse population of adolescents and young adults (AYA) with kidney transplants (KT) or spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Spina Bifida; Kidney Transplant