TAKE IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial

描述（由申请人提供）：拟议研究的主要目的是提高青少年肾移植受者的药物依从性。具体目标是在随机临床试验中确定结构化多组分干预在改善抗排斥药物依从性和移植结局方面的疗效，并确定与依从性独立相关的医疗保健系统特征。药物不依从性是15-30%的美国儿童的主要问题，这些儿童患有慢性疾病，导致显著的发病率、死亡率和相关费用。改善肾移植人群依从性的干预措施将改善该人群的生存率和生活质量，并可能适用于其他人群。美国和加拿大7个儿科移植中心的肾移植受者将被邀请参加。参与者将被随机分配到对照组或干预组。将使用电子药物监测多剂量药盒（Medminder）测量所有受试者的依从性。入组后将有3个月的导入期，在此期间将隐藏分组，不进行干预。在3个月访视时，分配到干预组的受试者将组成一个依从性支持团队，包括受试者、父母一方或双方以及一名不是治疗团队成员的研究协调员。在同一次访问中，协调员将提供标准化的依从性教育，并将启动一个新颖的20-30分钟的行为干预，将解决问题的技能与实施意图（具体的行动计划，其中个人指定，在一个如果-那么应急格式，何时，何地以及如何他或她将执行一个行为，以培养习惯的目标）相结合。该干预措施将侧重于解决使用经验证的药物治疗障碍调查3确定的依从性障碍，并由参与者选择对他或她重要的障碍。随后的研究访视（间隔3个月）将包括教育部分的简要版本，以及实施意图的审查和更新。在两次访视之间，协调员将保持每周（持续4周），然后每月通过简短的电话或短信签到与参与者联系。此外，Medminder将被配置为在整个干预间隔期间向干预组中的参与者提供警报，电话或短信剂量提醒。对照组受试者也将每隔3个月与主持人会面，但仅讨论一般健康和生活问题;他们不会收到剂量提醒。主要结果将是“服用依从性”-消耗的处方剂量的比例。还将评价适当的给药时间，以及药物水平的变异性（反映药物消耗的一致性）和移植结局。将比较干预组和对照组的依从性水平、依从性变化模式和移植结局。对收集的研究数据进行的次要观察性分析将确定与依从性独立相关的医疗保健系统因素。

DESCRIPTION (provided by applicant): The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence. Medication non-adherence is a major problem in the 15-30% of American children who have a chronic illness resulting in significant morbidity, mortality and related costs. An intervention to improve adherence in the kidney transplant population would improve survival and quality of life in this population, and may be applicable to other populations. Kidney transplant recipients at 7 pediatric transplant centers in the United States and Canada will be invited to participate. Participants will be randomly assigned to either the control or intervention group. Adherence will be measured in all participants using an electronic medication monitoring multi-dose pillbox: the Medminder. Enrolment will be followed by a 3-month run-in period, during which group allocation will be concealed and no intervention administered. At the 3-month visit, participants assigned to the intervention group will form an Adherence Support Team including the participant, one or both parents, and a study facilitator who is not a member of the treating team. At the same visit the facilitator will provide standardized adherence education, and will initiate a novel 20-30 min. behavioral intervention, which combines problem-solving skills with implementation intentions (concrete action plans in which an individual specifies, in an if-then contingency format, when, where and how he or she will perform a behavior, with the goal of developing habits). This intervention will focus on addressing adherence barriers identified using the validated Medication Barriers Survey 3 and selected by the participant as important to him or her. Subsequent study visits, at 3-month intervals, will include a briefer versions of the educational component, and review and updating of implementation intentions. In between visits, the facilitator will maintain weekly (for 4 weeks), then monthly contact with participants via short phone or text-message check-ins. In addition, the Medminder will be configured to provide alarm, phone, or text message dose reminders to participants in the intervention group throughout the intervention interval. Control participants will also meet with the facilitator at 3-month intervals, but will simply discuss general health and life issues; they will not receive dose reminders. The primary outcome will be 'taking adherence' - the proportion of prescribed doses that were consumed. Appropriate timing of doses will also be evaluated, as will variability in medication levels (reflecting consistency of medication consumption), and graft outcomes. Level of adherence, patterns of change in adherence, and graft outcomes will be compared between intervention and control groups. Secondary observational analyses of collected study data will identify healthcare systems factors independently associated with adherence.