Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial (U-REAACT)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Spina Bifida; Kidney Transplant

Treatments: Behavioral: Behavioral Feedback and Economic Incentives: Arm 2; Behavioral: Behavioral Feedback and Economic Incentives: Arm 1

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03045276

1R01DK110749 (U.S. NIH Grant/Contract)

16-013000

Details and patient eligibility

About

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).

Full 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.

Enrollment: 465 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females age 12-24 years.
2. Kidney Transplant subjects must be greater than 3 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 3 months post-transplant.
8. Unable to perform CIC.
9. Prescribed Immunosuppressive medications once per day.
10. Provider recommendations of CIC once per day

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

465 participants in 2 patient groups

Arm 1 - No Feedback, Minimum Incentive

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Feedback and Economic Incentives: Arm 1

Arm 2 - Feedback, Maximum Incentive

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Feedback and Economic Incentives: Arm 2