Current Environment:

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).

Conditions

Spina Bifida, Kidney Transplant

Recruitment Status

Completed

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.

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

Intervention

Intervention Type

Intervention Name

Behavioral

Behavioral Feedback and Economic Incentives: Arm 1

Behavioral

Behavioral Feedback and Economic Incentives: Arm 2

Phase

Not Applicable

Gender

All

Minimum Age

12 Years

Maximum Age

24 Years

Download Date

May 17, 2022

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: