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

本次提交汇集了领先的儿科移植中心，使用NIDDK的 协作多中心试验（U 01）资助机制，研究创新战略， 通过提高对药物治疗方案的依从性来改善移植结果。治疗依从性差 免疫抑制药物是青少年器官移植排斥反应的主要原因 受惠人士我们将研究一种量身定制的遥测干预措施， 通过提高对肝脏移植青少年的药物依从性来减少排斥反应， 移植本研究将使用药物水平变异性指数（MLVI）来告知 干预MLVI是一种创新的依从性生物标志物，可计算 随着时间的推移，免疫抑制剂药物血液水平之间的变异性（较高的变异性= 更糟糕的是）。它是器官排斥反应的可靠预测因子（MLVI>2表示具有临床意义 不依从，导致更高的拒绝风险）。高危青少年肝移植受者 (MLVI>2）将被招募到几个移植中心的随机对照试验中。在 主动遥测干预臂（通过电话、FaceTime ®或Skype ®进行管理 接口），经验丰富的介入医生将使用 标准化但灵活的干预策略。干预措施包括解决 与自我护理相关的心理回避，还包括提醒和问题- 解决已确定的遵守障碍。对照组参与者将继续接受 在现场的护理标准。本研究将专门招募高危患者， 通过MLVI标记监测他们的进展，并根据依从性调整干预措施 在整个2年的试验期间监测结果。因此，本研究将调查 创新的“个性化医疗”方法，以远程干预为目标。

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.