System CHANGE: An RCT for Medication Adherence in Kidney Transplant Recipients

描述（由申请人提供）：SystemCHANGE：成人肾移植受者药物依从性的RCT以肾移植（KT）受者为例，我们的目标是开发和测试增加慢性病成人药物依从性的干预措施。在成人KT接受者中，不依从免疫抑制药物（MNA）是不良结局的主要预测因素，包括排斥反应、肾功能丧失和死亡。令人震惊的是，三分之一的KT患者经历了MNA，尽管这个问题是可以预防的。依从性干预研究已证明对急性和慢性疾病患者的疗效甚微，对成人KT接受者无效。本R01将采用随机对照试验设计和注意力对照组，测试一种创新的6个月SystemCHANGE干预，以增强成人非依从性KT接受者的免疫抑制药物依从性。在我们的试点研究中，这种干预措施显示出很大的希望，增加了1.4的大效应量。立足于社会生态模型，SystemCHANGE旨在通过识别和塑造常规，在常规中涉及支持他人，并通过小型患者主导实验使用药物服用反馈来改变和维持行为，从而系统地改善药物依从性行为。将通过电子监测测量药物依从性。将通过评价6个月维持治疗期间两组之间的差异来检查药物依从性持续性。将检查药物依从性的中介者和调节者。将对健康结果进行比较，并进行成本效益分析。

DESCRIPTION (provided by applicant): SystemCHANGE: An RCT for Medication Adherence in Adult Kidney Transplant Recipients With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and test interventions that increase medication adherence in chronically ill adults. Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of KT patients experience MNA even though the problem is preventable. Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design with an attention- control group, this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive medication adherence in adult non-adherent KT recipients. This intervention shows great promise for increasing adherence with a large effect size of 1.4 in our pilot study. Grounded in the socio- ecological model, SystemCHANGE seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. Medication adherence will be measured by electronic monitoring. Medication adherence persistence will be examined by evaluating the difference between the two groups during the 6-month maintenance phase. Mediators and moderators of medication adherence will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be conducted.