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

系统变革：肾移植受者药物依从性的随机对照试验

• 批准号: 9066682
• 负责人: Donna K Hathaway
• 金额: $ 61.69万
• 依托单位: UNIVERSITY OF MISSOURI KANSAS CITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9066682
• 关键词: Acute; Address; Adherence; Adult; Appointment; Attention; Attitude; Behavior; Behavior Therapy; Behavioral; Belief; Cardiovascular Diseases; Cessation of life; Chronic; Chronic Disease; Chronic Kidney Failure; Chronically Ill; Cognition; Cognitive; Control Groups; Cost Effectiveness Analysis; Creatinine; Data; Diabetes Mellitus; Disease; Dose; Electronics; Environment; Ethnic Origin; Evaluation; Feedback; Goals; Graft Rejection; Health; Health Care Costs; Health Personnel; Health behavior; Healthcare; Healthy People 2020; Hospitalization; Immunosuppressive Agents; Individual; Infection; Intervention; Intervention Studies; Kidney; Kidney Transplantation; Knowledge; Lead; Length of Stay; Link; Maintenance; Measures; Mediator of activation protein; Meta-Analysis; Minor; Modeling; Monitor; Morbidity - disease rate; Organ; Outcome; Patients; Pattern; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Randomized Controlled Trials; Research; Role; Sampling; Self Management; Shapes; Social support; System; Testing; Time; Translating; Transplant Recipients; Transplantation; Work; base; behavior change; cost; cost effective; cost effectiveness; disability; effective intervention; experience; follow-up; forgetting; improved; innovation; medication compliance; patient oriented; programs; research study; skills; stem; trial design

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.

描述（由申请人提供）： SystemCHANGE：成人肾移植受者药物依从性的随机对照试验 以肾移植 (KT) 受者作为我们的样本人群，我们的目标是开发和测试提高慢性病成人药物依从性的干预措施。在成年 KT 接受者中，不坚持使用免疫抑制药物 (MNA) 是不良结果的主要预测因素，包括排斥反应、肾功能丧失和死亡。令人震惊的是，三分之一的 KT 患者会出现 MNA，尽管这个问题是可以预防的。依从性干预研究已证明，对于患有急性和慢性疾病的人来说效果有限，而对于成年 KT 接受者则无效。该 R01 将使用注意力控制组的随机对照试验设计来测试创新的 6 个月 SystemCHANGE 干预措施，以提高成年非依从性 KT 接受者的免疫抑制药物依从性。在我们的试点研究中，这种干预措施显示出提高依从性的巨大希望，其效果大小为 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利用用药反馈来改变和维持行为，从而系统地改善药物依从性行为。药物依从性将通过电子监控进行测量。将通过评估 6 个月维持阶段期间两组之间的差异来检查药物依从性的持久性。将检查药物依从性的中介因素和调节因素。将比较健康结果并进行成本效益分析。