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: 10493388
• 负责人: Rebecca Ellis
• 金额: $ 23.78万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10493388
• 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; innovation; intervention delivery; 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.

抽象的 不坚持服药会导致 CKD 患者无法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）并改善患者预后。虽然服药 不依从性是可以避免的，超过 50% 的 CKD 患者经历过这个问题和依从性 对于慢性病患者（例如慢性肾病患者）缺乏干预措施。该项目将测试 创新数字健康 SystemCHANGE™ 干预 (SystemCHANGE™-Digi) 以改善药物治疗 与患者教育的注意力控制相比，坚持使用中断 RAAS 的药物 (Control-Digi) 治疗依从性差的 CKD 患者。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，确定两种干预措施是否可接受且可信，并生成初步结果 CKD 干预组和注意对照组药物依从性结果的疗效 服用从两个大型医疗保健系统招募的 RAAS 抑制药物的患者。经过2个月的 筛选期间，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、结果预期和可信度 使用定性和定量数据。目标 2. 评估 SystemCHANGE™-Digi 与 Control-Digi 对药物依从性（主要结果）和个人系统行为（机制 行动）在第 8 周和第 12 周。 66 名患有 CKD 且对 RAAS 抑制依从性较差的个体的样本 药物将随机分配给：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、环境和其他重要因素，并通过持续的自我改进过程来 使用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 药片。 SystemCHANGE™-Digi 通过 7 次护士干预师指导的远程医疗会议和每周一次的方式提供 反馈报告通过彩信服务 (MMS) 发送到参与者的平板电脑，为期 6 周。这 注意力控制（患者教育）与 SystemCHANGETM 中护士干预员花费的时间相匹配 干预和传送相同数量的彩信。数据收集将在基线时完成， 8周，12周。对于目标 1，列出了对可接受性、结果预期和可信度的反应 将使用联合显示表将项目与定性数据结合起来。对于目标 2，将估计效应大小 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，对其他人群规定的每日用药方案具有广泛的转化影响。