The broad goal of this study is to improve treatment adherence for adolescents and young adults (AYA) with kidney transplant and spina bifida, two of the most burdensome kidney and urologic conditions. Nonadherent AYA with transplants are primed to spend more of their lifetime on dialysis, leading to tremendous loss in quality of life, increased co-morbidities and increased costs. Similarly, nonadherent AYA with spina bifida experience high rates of kidney damage, infections and hospitalizations. This project?s specific aims are: 1) to determine, in a randomized clinical trial, the efficacy of a 6-month mobile health based intervention, using text messaging, tailored feedback and financial incentives to improve treatment adherence for AYA with kidney transplants and those with spina bifida and neurogenic bladder, 2) to test the sustainability of the intervention?s effects and 3) to identify psychosocial correlates of behavior change. AYA with kidney transplant or spina bifida with neurogenic bladder across four large pediatric academic centers in the United States will be invited to participate. At enrollment, all participants will gain access to the well-established, NIH funded Way to Health web-based platform, an automated behavioral intervention delivery system. During a 3-month run-in, all participants will receive text reminders for medication taking or cathing. They will report their adherence to Way to Health by taking a photo of their medicines or catheter in hand at the time of performing their treatment. After run-in, they will be randomized to one of two treatment arms. Arm 1 will continue to receive text reminders and be able to log in to Way to Health to review their adherence patterns and educational modules. They will receive $2/week to report their weekly adherence with photos, but remuneration is not contingent on any adherence goal. Arm 2 will receive text reminders, but will also receive positively-framed feedback on behavior directly to their phone, with a larger incentive of $10/week if they meet a weekly adherence goal. The primary outcome is improvement and consistency in adherence between run-in and end of intervention. We will also examine sustainability in adherence between the end of the 6-month intervention and a 6-month follow-up period in which Arm 2 financial incentives are tapered off. Lastly, we will examine changes in self-efficacy, perceived barriers and knowledge as mediators of behavior change, between run-in and end of intervention. By applying an intervention to support AYA with kidney transplants and spina bifida in their ability to comply with treatment regimens, we will help them manage their disease burdens and expand their opportunities for better quality and duration of life. This project?s aims are well matched to the NIDDK?s mission to supportive research efforts to improve health and save lives.

Public Health Relevance

U-REAACT (Urological and Renal disease Engaging Adolescents in Adherence Collaborative Trial) is a randomized controlled trial designed to improve treatment adherence for adolescents and young adults (AYA) with kidney transplants and those with spina bifida, who must interrupt their daily lives frequently to take medicines or self-catheterize. This study aims to test an innovative strategy to help them improve their treatment adherence, using mobile phone-based technologies with text reminders, tailored feedback, education and financial incentives. This research is highly relevant to public health as it targets improving health outcomes through engaging AYA with phones and could, if proven effective, be easily catered to other chronic disease populations.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK110749-04
Application #
9697814
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Mendley, Susan Ruth
Project Start
2016-08-01
Project End
2021-05-31
Budget Start
2019-06-01
Budget End
2020-05-31
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Children's Hospital of Philadelphia
Department
Type
DUNS #
073757627
City
Philadelphia
State
PA
Country
United States
Zip Code
19146
Nazarian, S M; Peng, A W; Duggirala, B et al. (2018) The kidney allocation system does not appropriately stratify risk of pediatric donor kidneys: Implications for pediatric recipients. Am J Transplant 18:574-579
Amaral, Sandra; Furth, Susan (2017) Public health: Public investment in childhood health: worth the cost. Nat Rev Nephrol 13:386-388
Amaral, Sandra; Neu, Alicia (2016) Recurrent FSGS Postkidney Transplant: Moving the Needle Forward. Clin J Am Soc Nephrol 11:1932-1934