Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

Conditions
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Spina Bifida, Kidney Transplant

Intervention / Treatment
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* Behavioral: Behavioral Feedback and Economic Incentives: Arm 1
* Behavioral: Behavioral Feedback and Economic Incentives: Arm 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 - No Feedback, Minimum Incentive<br>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. | Behavioral: Behavioral Feedback and Economic Incentives: Arm 1<br>* 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.<br>|
| Active Comparator: Arm 2 - Feedback, Maximum Incentive<br>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. | Behavioral: Behavioral Feedback and Economic Incentives: Arm 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month) | Participants who do not submit the correct number of pictures within the prescribed window of their expected time due for treatment will be counted as non-adherent for that episode of med taking/cathing. The mean percentage of participants who achieved 85% adherence was calculated for each week from baseline (week 1) to the end of the 6 month time point (week 26). | baseline to 6 months | 
| Study Efficacy of Use of Way to Health Portal System | Statistical analysis of the number and timing of messages sent to the Way to Health portal as well as how often the participants used the portal will determine study efficacy. | 12.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pressure Per Unit Volume of Bladder of Spina Bifida Subjects | Urodynamic studies (UDS) in spina bifida subjects will test the change in bladder wall compliance, i.e. the change in pressure per unit volume of the bladder. | 12.5 months | 
| Change in Coefficient of Variation (CV) of Immunosuppressive Drug Levels (Tacrolimus or Sirolimus) Between the Baseline (run-in) and Intervention Period. | The difference between the coefficient of variation (CV) of immunosuppressive drug levels in kidney transplant patients at baseline and intervention period (6 months). CV was calculated using the average of three values of immunosuppressive drug levels at each time point. The change was calculated as the difference in mean value between baseline and 6 months. | baseline and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spina Bifida, Kidney Transplant