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

接受它：青少年对肾移植的依从性干预试验的有效性

• 批准号: 8830715
• 负责人: SUSAN L. FURTH
• 金额: $ 15.62万
• 依托单位: MCGILL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8830715
• 关键词: 19 year old; Acute; Address; Adherence; Adolescent; Age; American; Behavior; Behavior Therapy; Behavioral; Canada; Caring; Cessation of life; Characteristics; Child; Childhood; Chronic; Chronic Disease; Clinic; Clinical; Complex; Consumption; Control Groups; Data; Development; Dose; Education; Educational Intervention; Effectiveness of Interventions; Electronic Mail; Electronics; Enrollment; Failure; Future; Glomerular Filtration Rate; Goals; Graft Survival; Habits; Health; Health Care Costs; Healthcare Systems; Holidays; Immunosuppressive Agents; Individual; Insurance Coverage; Intervention; Intervention Trial; Kidney Transplantation; Life; Link; Measures; Medical; Methods; Monitor; Morbidity - disease rate; Nurses; Organ; Outcome; Parents; Participant; Patient Care; Patient Self-Report; Patients; Pattern; Pharmaceutical Preparations; Pharmacists; Population; Problem Solving; Provider; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Risk; Risk Factors; Running; Site; Specific qualifier value; Structure; Surveys; System; Tacrolimus; Teenagers; Telephone; Text; Therapeutic immunosuppression; Time; Training; Translating; Transplant Recipients; Transplantation; United States; Update; Visit; Youth; age group; arm; base; brief intervention; control trial; cost; effective intervention; graft failure; group intervention; hazard; improved; medication compliance; meetings; member; mortality; multi-component intervention; novel; novel strategies; primary outcome; prospective; secondary outcome; skills; success; tool; treatment as usual

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.

描述（由申请人提供）：拟议研究的广泛目的是改善青少年肾脏移植受者的药物依从性。具体目的是在一项随机临床试验中确定结构化的多组分干预措施在改善抗反应药物和移植结果方面的疗效，并确定与依从性独立相关的医疗保健系统的特征。在15-30％患有慢性疾病的美国儿童中，药物不遵守是一个主要问题，导致发病率明显，死亡率和相关成本。提高肾脏移植人群依从性的干预措施将改善该人群的生存和生活质量，并且可能适用于其他人群。将邀请美国和加拿大7个小儿移植中心的肾脏移植接受者参加。参与者将被随机分配到对照组或干预组。使用电子药物监测多剂量药盒：MedMinder，将在所有参与者中测量依从性。入学率将在3个月的磨合期之后进行，在此期间将隐藏组分配，并且不给予干预措施。在为期3个月的访问中，分配给干预小组的参与者将组成一个依从性支持团队，包括参与者，一个或两个父母以及不是治疗团队成员的学习促进者。在同一访问中，主持人将提供标准化的依从性教育，并将发起20-30分钟的小说。将解决问题的技能与实施意图相结合的行为干预（具体的行动计划，一个人以当时的应急形式指定，何时，何时何地和她将如何执行行为，以及养成习惯的目标）。这项干预措施将着重于解决使用经过验证的药物障碍调查3识别的依从性障碍，并由参与者选择对他或她很重要。随后的研究访问（以3个月的间隔）将包括教育组成部分的英国版本，并审查和更新实施意图。在两次访问之间，主持人将每周维持（4周），然后每月通过短电话或短信检查与参与者进行接触。此外，将在整个干预间隔内将MEDMINDER配置为向干预组的参与者提供警报，电话或短信剂量。控制参与者还将以3个月的间隔与主持人会面，但只会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“遵守” - 所消耗的规定剂量的比例。还将评估适当的剂量时机，药物水平的变异性（反映了药物消耗的一致性）和移植结果。在干预组和对照组之间，将比较依从性，依从性的变化模式和移植结果。对收集的研究数据的次要观察分析将确定与依从性独立相关的医疗保健系统因素。