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

描述(申请人提供)：SYSTEM CHANGE：成人肾移植受者用药依从性的随机对照试验以肾移植(KT)受者为我们的样本人群，我们的目标是开发和测试干预措施，以增加慢性病成人的用药依从性。在成人KT受者中，不坚持免疫抑制药物(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。令人担忧的是，三分之一的KT患者经历了MNA，尽管这个问题是可以预防的。坚持干预研究已被证明对那些患有急慢性疾病的人略微有效，而对成年KT接受者无效。使用随机对照试验设计和注意控制组，R01将测试一种创新的为期6个月的系统改变干预措施，以提高成年非粘附性KT患者对免疫抑制药物的依从性。在我们的初步研究中，这一干预措施显示出增加依从性的巨大希望，其效果大小为1.4。以社会生态模型为基础，SystemChANGE寻求通过识别和塑造例行公事、让其他人参与到例行公事中来支持他人，并通过患者主导的小型实验使用药物获取反馈来改变和维持行为，从而系统地改善服药依从性行为。用药依从性将通过电子监测进行衡量。在6个月的维持期内，将通过评估两组之间的差异来检查服药依从性。将对药物依从性的调解人和调解人进行检查。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.