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: 8324866
• 负责人: SUSAN L. FURTH
• 金额: $ 73.3万
• 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 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8324866
• 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）：拟议研究的主要目标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、多成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。对于 15-30% 患有慢性病的美国儿童来说，不坚持服药是一个主要问题，导致严重的发病率、死亡率和相关费用。提高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，并且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受邀参加。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 来测量所有参与者的依从性。注册后将有 3 个月的磨合期，在此期间将隐藏分组分配且不进行任何干预。在为期 3 个月的访视中，分配到干预组的参与者将组成一个依从性支持团队，其中包括参与者、父母一方或双方以及一名不属于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，并启动 20-30 分钟的新颖内容。行为干预，将解决问题的技能与实施意图相结合（具体的行动计划，其中个人以“如果-那么”应急格式指定他或她将在何时、何地以及如何执行某种行为，以养成习惯） 。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依从性障碍。随后的研究访问（每隔 3 个月一次）将包括教育部分的简要版本，以及实施意图的审查和更新。在访问之间，协调员将每周（持续 4 周）、然后每月通过短电话或短信签到与参与者保持联系。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。对照组参与者还将每隔 3 个月与辅导员会面一次，但只会讨论一般健康和生活问题；他们不会收到剂量提醒。主要结果是“服用依从性”——服用处方剂量的比例。还将评估适当的剂量时间、药物水平的变异性（反映药物消耗的一致性）和移植结果。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结果。对收集的研究数据进行二次观察分析将确定与依从性独立相关的医疗保健系统因素。