The TAKE-IT study: aims, design, and methods.
The TAKE-IT study: aims, design, and methods.
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DOI：
10.1186/1471-2369-15-139
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发表时间：
2014-08-30
期刊：
影响因子：
2.3
通讯作者：
TAKE-IT Study Group
中科院分区：
文献类型：
--
作者：
Foster BJ;Pai A;Zhao H;Furth S;TAKE-IT Study Group
迫切需要有效的干预措施，以提高青少年和年轻成人肾移植受者对免疫抑制药物的依从性。本文介绍了肾移植青少年依从性干预试验有效性研究(Take-IT)的目的、设计和方法。Take-IT是一项多中心、前瞻性、开放标签、平行的ARM随机对照试验，旨在确定以临床为基础的干预措施的有效性，包括教育、组织和行为因素，以改善青少年和年轻成人肾移植受者的免疫抑制药物依从性。年龄在11岁至24岁之间的个人，如果在移植后至少3个月内，并参加了八个参与的儿童肾脏移植计划之一，或其附属的成人移植计划，就有资格参加。所有参与中心都是加拿大或美国的三级儿科医院。在3个月的磨合期内，对所有参与者使用电子多剂量药盒监测依从性，然后进行12个月的干预间隔。主要结果是“服用依从性”，定义为通过电子监测测量的免疫抑制药物处方剂量的比例。所有参与者每隔3个月与研究“教练”会面一次。这项干预由训练有素的非专业人员实施，针对常见的遵守障碍。除了组成遵从性支持团队外，干预参与者还识别遵守的个人障碍，并使用以行动为重点的问题解决方案来解决这些障碍，将他们的电子遵从性数据反馈给他们，并可以选择接收电子邮件、短信或可视提示剂量提醒。控制组的参与者与教练会面，但不接受干预的其他部分。这项研究的目标是每组有75名参与者完成研究。自2012年2月开始招募以来，已接触198名青少年参加，其中130人已完成基线访问。截至2014年3月31日，已随机抽取125人，其中86人、68人、61人和50人分别完成了6个月、9个月、12个月和15个月的访问。ClinicalTrials.gov注册编号NCT01356277(2011年5月17日)。
Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed. This paper describes the aims, design, and methods of the Teen Adherence in Kidney transplant, Effectiveness of Intervention Trial (TAKE-IT) study. TAKE-IT is a multicentre, prospective, open-label, parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention, including educational, organizational, and behavioural components, in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients. Individuals between 11 and 24 years of age who are at least 3 months post-transplant and followed in one of the eight participating pediatric kidney transplant programs, or their affiliated adult transplant programs are eligible to participate. All participating centers are tertiary care pediatric hospitals in Canada or the United States. Adherence is monitored using an electronic multi-dose pillbox for all participants during a 3-month run-in period, followed by a 12-month intervention interval. The primary outcome is ‘taking adherence’, defined as the proportion of prescribed doses of immunosuppressive medications that were taken, as measured using electronic monitoring. All participants meet with the study ‘Coach’ at 3 month intervals. The intervention, administered by trained lay personnel, targets common adherence barriers. In addition to forming an Adherence Support Team, intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them, have their electronic adherence data fed back to them, and have the option to receive email, text message, or visual cue dose reminders. Participants in the control group meet with the coach but do not receive the other components of the intervention. The study aims to have 75 participants in each group complete the study. Since recruitment began in Feb. 2012, 198 adolescents have been approached to participate, of whom 130 have completed a baseline visit. As of March 31, 2014, 125 had been randomized, and 86, 68, 61, and 50 participants had completed 6-month, 9-month, 12-month, and 15-month visits respectively. Clinicaltrials.gov registration NCT01356277 (May 17, 2011).
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