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

改善接受肝移植的青少年的药物依从性：iMALT

• 批准号: 10021643
• 负责人: EYAL SHEMESH
• 金额: $ 99.7万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10021643
• 关键词: Acute; Address; Adherence; Admission activity; Adolescent; Adult; Biochemical Markers; Biological Markers; Blood; Caring; Cessation of life; Child; Childhood; Clinical; Clinical Trials Data Monitoring Committees; Data; Development; Elements; Enrollment; Enzymes; Goals; Grant; Health; Health Benefit; Immunosuppressive Agents; Incidence; Institutional Review Boards; Intervention; Intervention Studies; Letters; Liver; Malt Grain; Manuals; Masks; Measures; Metastatic Neoplasm to the Liver; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Organ; Organ Transplantation; Outcome; Participant; Patient Noncompliance; Patients; Pharmaceutical Preparations; Phase; Population; Problem Solving; Procedures; Prospective cohort study; Protocols documentation; Public Health; Publishing; Quality of life; Randomized Controlled Trials; Regimen; Research; Resources; Risk; Risk stratification; Self Care; Site; Solid; Standardization; Stress; Supervision; Telemetry; Telephone; Testing; Time; Training; Transplant Recipients; Transplantation; arm; base; clinical care; clinically significant; cost; cost efficient; electronic data capture system; experience; flexibility; group intervention; habituation; high risk; high-risk adolescents; improved; improved outcome; indexing; innovation; intervention effect; intervention participants; liver injury; liver transplantation; medication compliance; mortality; multi-site trial; novel; personalized medicine; post-transplant; psychologic; randomized trial; service utilization; sex; standard of care; telehealth; time use; transplant centers; transplantation medicine; treatment arm; treatment as usual

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.

本提交内容汇集了领先的儿科移植中心，使用 NIDDK 的 协作多中心试验（U01）资助机制，以研究创新策略 通过提高对药物治疗方案的依从性来改善移植结果。不遵守 免疫抑制剂是青少年移植器官排斥的主要原因 收件人。我们将研究量身定制的遥测干预措施，以减少患者数量 通过提高患有肝脏疾病的青少年的药物依从性而产生排斥反应 移植。本研究将使用药物水平变异指数 (MLVI) 来告知 干涉。 MLVI 是一种创新的依从性生物标志物，可计算依从性的程度 免疫抑制剂药物血药浓度随时间的变化（较高的变化= 依从性较差）。它是器官排斥的有力预测因子（MLVI>2 表示有临床意义 不依从，导致更高的拒绝风险）。高危青少年肝移植受者 (MLVI>2) 将参加多个移植中心的随机对照试验。在 主动遥测干预臂（通过电话、FaceTime® 或 Skype® 进行管理） 接口），经验丰富的干预专家将使用远程与患者沟通 标准化但灵活的干预策略。干预措施包括解决 与自我保健相关的心理回避，还包括提醒和问题- 解决已发现的依从障碍。控制臂参与者将继续收到 现场护理标准。该研究将专门招募高危患者，并将不断 通过 MLVI 标记监测他们的进展，并根据依从性调整干预措施 整个 2 年试验期间的监测结果。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。