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December 11, 2018

TAKE-IT TOO: Teen Adherence in KidnEy transplant,

Improving Tracking To Optimize Outcomes

Principal Investigators:Dr. Bethany Foster

Montreal Children’s Hospital of the MUHC

Dr. Annette DeVito Dabbs (site PI)

University of Pittsburgh Medical Center (UPMC)

Project Summary: 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 multi-component 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.

Inclusion criteria: Stage 1

Patients: Prevalent renal transplant recipients 12-24 y, who are ≥3 months post-transplant will be eligible. A minimum of 3 months post-transplant (no max.) will ensure medical stability and a substantial risk of non-adherence; non-adherence increases with increasing time since transplant. Individuals with significant neurocognitive disabilities limiting their ability to understand and participate in their own care (as judged by the parents and the healthcare team) will be excluded, as will patients unable to communicate in English or French (Montreal only). Patients will be eligible to participate even if a parent does not participate.

Parents of prevalent renal transplant recipients 12-17 y (followed in a participating transplant center) will be eligible. Parents of patients 18-24 years old will be excluded as the older aged group is expected to be primarily responsible for their own care, independent of their parents. One parent per family will be eligible to avoid redundant representation. Parents will be eligible to participate even if their child does not participate.

Transplant Healthcare professionals (HCP) Because the organization of care and resources available may differ substantially between countries and across centers, we will include HCP at all 7 sites to ensure greater generalizability of results. HCP participants will include representatives from the variety of disciplines typically involved in promoting medication adherence as deemed appropriate from each center. Appendix C provides the numbers of each type of HCP available at each site.

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