Improving Medication Adherence in adolescents who had a Liver Transplant: iMALT

这份意见书汇集了领先的儿科移植中心，使用NIDDK的 协作性多站点试验(U01)赠款机制，以研究创新战略 通过改善对药物治疗方案的依从性来改善移植结果。不遵守 免疫抑制药物是青少年器官移植排斥反应的主要原因 收件人。我们将研究一种量身定制的遥测干预措施，以减少患者数量 在有肝脏的青少年中，通过改善药物依从性而发生排斥反应的人 移植。这项研究将使用药物水平变异性指数(MLVI)来告知 干预。MLVI是一种创新的粘附性生物标志物，它可以计算 免疫抑制剂药物血药浓度随时间变化的变异性(更高的变异性= 遵守情况更差)。它是器官排斥反应的有力预测因子(MLVI和GT；2表示具有临床意义 不坚持，导致更高的拒绝风险)。高危青少年肝移植受者 (MLVI&GT；2)将在几个移植中心进行随机对照试验。在 主动遥测干预臂(通过电话、FaceTime®或Skype®进行管理 界面)，经验丰富的干预者将使用 规范但灵活的干预策略。干预包括寻址 心理回避与自我照顾有关，还包括提醒和问题- 解决已确定的遵守障碍。控制臂参与者将继续收到 现场的护理标准。这项研究将只招募高危患者，并将继续 通过MLVI标记监控他们的进展，并将根据遵守情况量身定做干预措施 在两年的试验期内监测结果。因此，这项研究将调查 创新的“个人化医疗”方法，针对远程干预努力。

This submission brings together leading pediatric transplant centers, using the NIDDK's collaborative multisite trial (U01) grant mechanism, to investigate an innovative strategy to improve transplant outcomes by improving adherence to medication regimens. Nonadherence to immunosuppressant medications is the leading cause of organ rejection in adolescent transplant recipients. We will investigate a tailored telemetric intervention reduce the number of patients who have a rejection by improving adherence to medications in adolescents who had a liver transplant. This study will use the Medication Level Variability Index (MLVI) to inform the intervention. The MLVI is an innovative biomarker of adherence which calculates the degree of variability between immunosuppressant medication blood levels over time (higher variability = worse adherence). It is a robust predictor of organ rejection (MLVI>2 denotes clinically significant nonadherence, leading to higher rejection risk). At-risk adolescent liver transplant recipients (MLVI>2) will be enrolled in a randomized controlled trial across several transplant centers. In the active telemetric intervention arm (administered via telephone, FaceTime ® or Skype ® interfaces), experienced interventionists will remotely communicate with patients using a standardized but flexible intervention strategy. The intervention includes addressing psychological avoidance associated with self-care, and further includes reminders and problem- solving of identified barriers to adherence. Control arm participants will continue to receive standard-of-care at the site. The study will exclusively enroll at-risk patients, will continually monitor their progress through the MLVI marker, and will tailor the intervention to the adherence monitoring findings throughout the 2 year trial period. This study will thus investigate an innovative “personalized medicine” approach to target a remote intervention effort.