Medication Adherence Given Individual systemCHANGE™ in Advancing Nephropathy (MAGICIAN) Pilot Study

摘要 药物不依从性阻止CKD患者从药物中获得全部益处， 抑制肾素-血管紧张素-醛固酮系统（RAAS），改善患者预后。虽然药物 不依从是可以避免的，超过50%的CKD患者经历过这种问题和依从性 缺乏对慢性病患者（如CKD患者）的干预措施。该项目将测试一个 创新的数字健康系统CHANGETM干预（SystemCHANGE™-Digi），以改善药物治疗 与患者教育的注意力控制相比，坚持中断RAAS的药物治疗 （Control-Digi）在药物依从性差的CKD患者中。本研究的目的是 比较SystemCHANGE™-Digi实验干预与注意力控制的可接受性， Control-Digi，以确定两种干预措施是否可接受和可信，并生成初步的 干预组和注意力控制组对慢性肾病患者药物依从性结局的疗效 从两个大型医疗保健系统招募的服用RAAS抑制药物的患者。经过两个月的 在筛选期，在基线、8周和12周评估结果。具体目标是：目标1。 比较SystemCHANGE™-Digi与Control-Digi的可接受性、预期结果和可信度 使用定性和定量数据。目标二。估计SystemCHANGE™-Digi与 Control-Digi对药物依从性（主要结局）和个人系统行为（ 在第8周和第12周。66名CKD患者的样本，对RAAS抑制剂的依从性差， 药物将被随机分配到：1）SytemCHANGE™-Digi或2）注意力控制-Digi。 SystemCHANGETM利用人们已经建立的可靠的以人为本的系统-他们的 日常生活，环境和重要的人，并通过使用持续的自我改善过程， 将药物服用与现有的可靠的个人系统相结合。SystemCHANGETM -Digi利用 远程保健和移动的技术，以提供干预内容和流程改进反馈， 平板电脑. SystemCHANGE™-Digi通过7次护士干预指导的远程医疗会议和每周一次的 通过多媒体信息服务（MMS）向参与者的平板电脑发送反馈报告，为期6周。的 注意力控制（患者教育）与SystemCHANGETM中的护士干预师花费的时间相匹配 干预和发送相同数量的MMS消息。将在基线时完成数据收集， 8周和12周。对于目标1，对可接受性、预期结果和可信度的答复列表 将使用联合显示表将项目与定性数据合并。对于目标2，将估计效应量 通过将ANCOVA模型与治疗组以及依从性和个人系统行为的结果拟合。 这项研究将提供有关SystemCHANGE™功效的新知识，以提高药物依从性 在这一人群中，对其他人群的每日药物治疗方案具有广泛的转化影响。

ABSTRACT Medication nonadherence prevents people with CKD from achieving the full benefits from medications that inhibit the renin-angiotensin-aldosterone system (RAAS) and improve patient outcomes. Although medication nonadherence is avoidable, more than 50% of people with CKD experience this problem and adherence interventions are lacking for people with chronic illness such as those with CKD. This project will test an innovative digital health SystemCHANGETM intervention (SystemCHANGE™-Digi) to improve medication adherence to medications that interrupt the RAAS compared with an attention control of patient education (Control-Digi) among people with CKD who have poor medication adherence. The purpose of this study is to compare the acceptability of the SystemCHANGE™-Digi experimental intervention vs. attention control, Control-Digi, to determine if both interventions are acceptable and credible, and to generate preliminary efficacy on the outcome of medication adherence between the intervention and attention control groups in CKD patients taking RAAS inhibiting medications recruited from two large health care systems. Following a 2-month screening period, outcomes are assessed at baseline, 8 weeks, and 12 weeks. Specific aims are to: Aim 1. Compare acceptability, outcome expectancy and credibility of the SystemCHANGE™-Digi versus Control-Digi using qualitative and quantitative data. Aim 2. Estimate preliminary efficacy of SystemCHANGE™-Digi versus Control-Digi on medication adherence (primary outcome) and personal systems behavior (mechanism of action) at 8 and 12 weeks. A sample of 66 individuals with CKD and poor adherence to a RAAS inhibiting medication will be assigned at random to: 1) SytemCHANGE™-Digi or a 2) attention control-Digi. SystemCHANGETM harnesses reliable person-centered systems that people have already established – their daily routines, the environment, and important others, and by using a continuous self-improvement process to align medication-taking with existing reliable personal systems. SystemCHANGETM -Digi capitalizes on telehealth and mobile technologies to deliver intervention content and process improvement feedback by tablet. SystemCHANGE™-Digi is delivered in 7 nurse-interventionist guided telehealth sessions and weekly feedback reports sent to participants’ tablets by multimedia messaging service (MMS) for 6 weeks. The attention control (patient education) matches the time spent with a nurse-interventionist in SystemCHANGETM intervention and delivery of the same number of MMS messages. Data collection will be completed at baseline, 8 weeks, and 12 weeks. For Aim 1, tabulated responses to acceptability, outcome expectancy and credibility items will be combined with qualitative data using joint display tables. For Aim 2, effect sizes will be estimated by fitting ANCOVA models with treatment group and outcomes of adherence and personal systems behavior. This research will provide new knowledge about SystemCHANGE™ efficacy to improve medication adherence in this population, with broad translational impact to other populations prescribed daily medication regimens.