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

描述（由申请人提供）：拟议研究的广泛目的是提高青少年肾移植受者的药物依从性。具体目的是通过一项随机临床试验，确定结构化、多组分干预在提高抗排斥药物依从性和移植结果方面的功效，并确定与依从性独立相关的医疗保健系统的特征。在患有慢性疾病的15-30%的美国儿童中，药物不依从性是一个主要问题，导致严重的发病率、死亡率和相关费用。改善肾移植人群依从性的干预措施将提高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。所有参与者的依从性将使用电子药物监测多剂量药盒：Medminder进行测量。入组后将有3个月的磨合期，在此期间，分组分配将被隐藏，不进行干预。在为期3个月的访问中，被分配到干预组的参与者将组成一个依从性支持小组，包括参与者、父母一方或双方，以及一名非治疗小组成员的研究协调员。在同一次访问中，调解人将提供标准化的依从性教育，并将启动一项新颖的20-30分钟的行为干预，该干预将解决问题的技能与实施意图相结合（具体的行动计划，个人以“如果-然后”的形式指定，他或她将在何时、何地以及如何执行一种行为，以培养习惯）。该干预措施将侧重于解决使用经过验证的药物障碍调查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。随后每隔3个月进行一次研究访问，其中将包括较简短的教育内容，并审查和更新实施意图。在访问期间，调解人将保持每周（为期4周），然后每月通过短电话或短信与参与者联系。此外，Medminder将被配置为在整个干预间隔期间向干预组的参与者提供警报、电话或短信剂量提醒。控制组参与者也将每3个月与调解人会面一次，但只讨论一般的健康和生活问题；他们将不会收到剂量提醒。主要结果将是“服药依从性”——服用处方剂量的比例。还将评估适当的剂量时机，以及药物水平的可变性（反映药物消耗的一致性）和移植物结果。将比较干预组和对照组之间的依从性水平、依从性变化模式和移植物结果。收集的研究数据的二次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.