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

描述（由申请人提供）：SystemCHANGE：一项成人肾移植受者药物依从性的随机对照试验以肾移植（KT）受者为样本人群，我们的目标是开发和测试增加慢性疾病成人药物依从性的干预措施。在成人KT受体中，不坚持使用免疫抑制药物（MNA）是不良预后的主要预测因素，包括排斥反应、肾丢失和死亡。令人震惊的是，三分之一的KT患者经历了MNA，尽管问题是可以预防的。依从性干预研究已证明对那些患有急性和慢性疾病的人略微有效，对成人KT接受者无效。采用随机对照试验设计和注意对照组，本R01将测试一种创新的6个月SystemCHANGE干预，以增强成人非依从性KT受体的免疫抑制药物依从性。在我们的初步研究中，该干预措施显示出增加依从性的巨大希望，其效应量为1.4。SystemCHANGE以社会生态模型为基础，旨在通过识别和塑造常规，让支持性他人参与常规，以及通过小型患者主导实验使用药物反馈来改变和维持行为，系统地改善药物依从性行为。药物依从性将通过电子监控来衡量。通过评估两组在6个月维持期的差异来检查药物依从性的持久性。研究药物依从性的调节因子和调节因子。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.