Medication non-adherence is a major problem in kidney transplant recipients, and is considered the most important factor limiting long-term graft survival; poor adherence results in significant morbidity, mortality and related costs. Young people 12-24 years of age are at particularly high risk for non- adherence and graft failure. Clinically feasible, effective interventions to improve adherence are urgently needed to improve survival and quality of life in this population. The goal of this prospective, 3-stage, sequential, multi-center study is to adapt the successful TAKE-IT intervention, previously tested in a controlled setting, for use in `real world' clinical care. We will apply the principles of user-centered design and use stakeholders' input to adapt the TAKE-IT intervention, and develop (in collaboration with Vaica Medical) a novel portable, multi-dose electronic medication-monitoring pillbox (e-pillbox).
The specific aims of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for `real world' use; (2) To iteratively design and evaluate the usability and acceptability of an e-pillbox (with companion adherence- tracking website) with stakeholders in controlled and field settings; (3) To conduct a pilot cluster randomized trial (CRT) testing the adapted intervention, including the e-pillbox, to assess feasibility of a larger CRT, further refine the intervention, and estimate key statistical parameters needed to plan the future definitive CRT. In Stage 1 of this study, separate focus groups of patients and parents will be conducted at transplant centers in the United States and Canada to optimize effectiveness and acceptability of the multicomponent intervention and inform e-pillbox design. Focus groups with HCP will identify ways to facilitate implementation of an adherence-promoting intervention in clinical practice. In Stage 2, patients will participate in a series of one-on- one device-development sessions, providing input and feedback on the usability and design of the e-pillbox. HCP will also provide input and feedback on the design of the adherence-tracking website. In Stage 3 patients will be randomized, by center, to the new intervention, or usual care (control), and their adherence measured with the e-pillbox.

Public Health Relevance

Medication non-adherence is a major cause of morbidity and mortality, and is believed to be responsible for millions of dollars of potentially avoidable healthcare costs. Non-adherence among kidney transplant recipients may result in failure of the transplanted kidney, dramatically increasing the risk of death in the recipient, and increasing the already large discrepancy between organs available for transplant and patients in need. The study described in this application seeks to understand the priorities and preferences of young transplant recipients, their parents, and the healthcare professionals taking care of them in order to design a portable multi-dose electronic monitoring device for young people and companion adherence-tracking website, and adapt a successful adherence intervention to ensure that it is practical to use in the clinical setting.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project (R01)
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Special Emphasis Panel (ZDK1)
Program Officer
Mendley, Susan Ruth
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Mcgill University Health Center Research Institute
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H3 2R9
Dew, Mary Amanda; Posluszny, Donna M; DiMartini, Andrea F et al. (2018) Posttransplant Medical Adherence: What Have We Learned and Can We Do Better? Curr Transplant Rep 5:174-188