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

进展性肾病 (MAGICIAN) 试点研究中给予个体的药物依从性系统变化™

• 批准号: 10372503
• 负责人: Rebecca Ellis
• 金额: $ 19.81万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10372503
• 关键词: Address; Adherence; American; Analysis of Covariance; Behavior; Behavioral Mechanisms; Cardiovascular Diseases; Cessation of life; Chronic Disease; Chronic Kidney Failure; Cognitive Therapy; Comprehensive Health Care; Consent; Control Groups; Country; Data; Data Collection; Diabetes Mellitus; Disease Progression; Education; Eligibility Determination; Environment; Expectancy; Feedback; Future; Health; Health Personnel; Healthcare Systems; Individual; Interruption; Intervention; Joints; Kidney Diseases; Kidney Transplantation; Knowledge; Literature; Measures; Meta-Analysis; Methods; Modeling; Morbidity - disease rate; Multimedia; Nurses; Outcome; Participant; Patient Education; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Positioning Attribute; Process; Randomized; Randomized Controlled Trials; Recommendation; Regimen; Renin-Angiotensin-Aldosterone System; Reporting; Research; Sampling; Science; Self Management; Services; Site; System; Tablets; Telephone; Testing; Time; Translating; Transplant Recipients; Treatment outcome; Visit; Work; attentional control; base; blood pressure reduction; compliance behavior; design; digital health; disorder risk; efficacy trial; evidence based guidelines; experience; health care delivery; improved; inhibitor/antagonist; innovation; mHealth; medication compliance; medication nonadherence; mobile computing; novel; patient population; person centered; post intervention; prevent; primary outcome; recruit; response; screening; telehealth; theories; translational impact; treatment group

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.

摘要 不坚持用药阻止CKD患者从以下药物中获得全部好处 抑制肾素-血管紧张素-醛固酮系统(RAAS)，改善患者预后。虽然药物治疗 不坚持是可以避免的，超过50%的CKD患者经历过这种问题和坚持 对慢性病患者，如慢性肾脏病患者缺乏干预措施。该项目将测试一个 创新的数字健康系统改善药物治疗的畅通干预(™-DIGI) 坚持中断RAAS的药物与注意控制患者教育的比较 (CONTROL-DIGI)在服药依从性较差的CKD患者中。这项研究的目的是 比较系统改变™-DIGI实验干预与注意力控制的可接受性， Control-Digi，以确定这两种干预措施是否可接受和可信，并生成初步 干预组与注意对照组对慢性肾脏病患者用药依从性的影响 服用RAAS抑制药物的患者从两个大型医疗保健系统招募。在经历了2个月的 在筛查期间，在基线、8周和12周评估结果。具体目标是：目标1. ™-DIGI与对照-DIGI系统的可接受性、结果预期和可信度的比较 使用定性和定量的数据。目的2.评价™-DIGI系统的初步疗效。 控制-数字关于服药依从性(主要结果)和个人系统行为(机制 行动)8周和12周。66例慢性肾脏病患者对RAAS抑制剂依从性差的样本 药物将随机分配给：1)SytemChange™-DIGI或2)注意力控制组-DIGI。 系统变更利用人们已经建立的可靠的以人为中心的系统-他们的 日常生活、环境和重要的其他方面，并通过使用持续的自我改进过程来 使服药与现有可靠的个人系统保持一致。SystemCHANGETM-Digi利用 远程医疗和移动技术通过以下方式提供干预内容和流程改进反馈 平板电脑。SYSTEM CHANGE™-DIGI通过7次护士-干预者指导远程保健会议和每周提供 通过彩信服务(MMS)将反馈报告发送到参与者的平板电脑，为期6周。这个 注意力控制(患者教育)与系统变更中的护士-干预者所花费的时间相匹配 干预和传递相同数量的MMS消息。数据收集将在基线时完成， 8周和12周。目标1，对可接受性、预期结果和可信度的列表答复 项目将使用联合显示表格与定性数据相结合。对于目标2，将估计影响的大小 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进行拟合。 这项研究将为提高用药依从性提供新的关于系统™疗效的认识 在这一人群中，具有广泛翻译影响的其他人群开出的每日用药方案。