TAKE-IT TOO: Teen Adherence in KidnEy transplant Improving Tracking To Optimize Outcomes

项目概述：药物不依从性是肾移植受者的一个主要问题， 被认为是限制移植物长期存活的最重要因素；粘附性差会导致显著的 发病率、死亡率和相关费用。12-24岁的年轻人患非糖尿病的风险特别高 粘连和移植失败。临床上可行的、有效的干预措施以提高依从性刻不容缓 需要改善这一人群的生存和生活质量。这个前瞻性的3阶段的目标是， 序贯、多中心研究是为了适应成功的Take-IT干预，之前在一项对照试验中 环境，用于“真实世界”的临床护理。我们将运用以用户为中心的设计和使用原则 利益相关者的意见，以适应Take-IT干预，并(与Vaica Medical合作)制定 新型便携式、多剂量电子用药监测药盒(电子药盒)。这项研究的具体目的 是：(1)了解利益相关者(肾移植接受者、父母和 医疗保健专业人员(医疗保健专业人员))，以优化Take-IT干预，以使用“真实世界”；(2) 迭代地设计和评估电子邮箱的可用性和可接受性(附带坚持- 跟踪网站)与受控和现场环境中的利益攸关方合作；(3)进行随机分组试点 试验(CRT)测试适应的干预措施，包括电子药箱，以评估更大CRT的可行性，进一步 细化干预措施，并估计规划未来最终CRT所需的关键统计参数。在……里面 在这项研究的第一阶段，患者和父母的单独焦点小组将在#年的移植中心进行。 美国和加拿大将优化多元干预的有效性和可接受性 并告知电子地堡的设计。具有初级保健计划的焦点小组将确定促进实施 临床实践中的依从性促进干预。在第二阶段，患者将参与一系列一对一的 一个设备开发会议，就电子地堡的可用性和设计提供投入和反馈。 HCP还将就遵守情况跟踪网站的设计提供意见和反馈。在第三期患者中 将按中心随机分配到新的干预或常规护理(对照)，并测量他们的依从性 带着电子地堡。

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 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.