TAKE-IT TOO: Teen Adherence in KidnEy transplant Improving Tracking To Optimize Outcomes

TAKE-IT TOO：青少年对肾脏移植的依从性改善跟踪以优化结果

• 批准号: 9326283
• 负责人: ANNETTE J DE VITO DABBS
• 金额: $ 55.06万
• 依托单位: MCGILL UNIVERSITY HEALTH CTR RES INST
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9326283
• 关键词: 13 year old; Address; Adherence; Adolescent; Adolescent and Young Adult; Age; Age-Years; Behavior; Canada; Caring; Case Series; Cessation of life; Chronic; Clinical; Cluster randomized trial; Collaborations; Companions; Control Groups; Data; Device or Instrument Development; Devices; Dose; Education; Effectiveness; Effectiveness of Interventions; Ensure; Failure; Feedback; Focus Groups; Future; Goals; Graft Survival; Health Care Costs; Health Professional; Immunosuppressive Agents; Intervention; Intervention Trial; Kidney Transplantation; Life; Measures; Medical; Meta-Analysis; Monitor; Morbidity - disease rate; Multicenter Studies; Organ; Outcome; Parents; Participant; Patients; Pharmaceutical Preparations; Population; Preparation; Process; Quality of life; Randomized; Recommendation; Reporting; Risk; Sample Size; Series; Source; Teenagers; Testing; Text; Therapeutic immunosuppression; Time; Translating; Transplant Recipients; Transplantation; United States; age group; attentional control; base; clinical care; clinical practice; cost; design; effective intervention; experience; field study; graft failure; hazard; high risk; improved; improved outcome; iterative design; medication compliance; monitoring device; mortality; multi-component intervention; novel; portability; preference; prevent; prospective; successful intervention; tool; treatment as usual; usability; user centered design; web based interface; web interface; web site

Project Summary: Medication non-adherence is a major problem in kidney transplant recipients, and is considered the most important factor limiting long-term graft survival; poor adherence results in significant morbidity, mortality and related costs. Young people 12-24 years of age are at particularly high risk for non- adherence and graft failure. Clinically feasible, effective interventions to improve adherence are urgently needed to improve survival and quality of life in this population. The goal of this prospective, 3-stage, sequential, multi-center study is to adapt the successful TAKE-IT intervention, previously tested in a controlled setting, for use in `real world' clinical care. We will apply the principles of user-centered design and use stakeholders' input to adapt the TAKE-IT intervention, and develop (in collaboration with Vaica Medical) a novel portable, multi-dose electronic medication-monitoring pillbox (e-pillbox). The specific aims of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for `real world' use; (2) To iteratively design and evaluate the usability and acceptability of an e-pillbox (with companion adherence- tracking website) with stakeholders in controlled and field settings; (3) To conduct a pilot cluster randomized trial (CRT) testing the adapted intervention, including the e-pillbox, to assess feasibility of a larger CRT, further refine the intervention, and estimate key statistical parameters needed to plan the future definitive CRT. In Stage 1 of this study, separate focus groups of patients and parents will be conducted at transplant centers in the United States and Canada to optimize effectiveness and acceptability of the multicomponent intervention and inform e-pillbox design. Focus groups with HCP will identify ways to facilitate implementation of an adherence-promoting intervention in clinical practice. In Stage 2, patients will participate in a series of one-on- one device-development sessions, providing input and feedback on the usability and design of the e-pillbox. HCP will also provide input and feedback on the design of the adherence-tracking website. In Stage 3 patients will be randomized, by center, to the new intervention, or usual care (control), and their adherence measured with the e-pillbox.

项目摘要：药物不依从性是肾移植受者的主要问题， 被认为是限制移植物长期存活的最重要因素;粘附性差导致显著的 发病率、死亡率和相关费用。12-24岁的年轻人患非传染性疾病的风险特别高。 粘附和移植失败。迫切需要临床上可行的、有效的干预措施来提高依从性。 需要提高这一人群的生存率和生活质量。这个前瞻性的三阶段的目标， 一项连续的多中心研究是为了适应成功的TAKE-IT干预，之前在一个对照组中进行了测试。 设置，用于“真实的世界”临床护理。我们将应用以用户为中心的设计和使用原则 利益相关者的意见，以适应采取IT干预措施，并制定（与Vaica医疗合作） 新型便携式多剂量电子药物监测药盒（e-pillbox）。本研究的具体目的 （1）了解利益相关者（肾移植受者、父母和 医疗保健专业人员（HCP）），以优化“真实的世界”使用的TAKE-IT干预;（2） 反复设计和评估电子药丸盒的可用性和可接受性（伴随依从性- （3）在受控和实地环境中与利益攸关方进行试点分组， 试验（CRT）测试适应性干预，包括电子药盒，以评估更大CRT的可行性，进一步 完善干预措施，并估计计划未来确定CRT所需的关键统计参数。在 本研究的第一阶段，将在移植中心进行单独的患者和父母焦点小组 美国和加拿大优化多成分干预的有效性和可接受性 and inform通知e-pillbox电子药盒design设计.与HCP的焦点小组将确定促进实施 在临床实践中促进依从性的干预。在第二阶段，患者将参加一系列一对一的 一次器械开发会议，提供关于e-pillbox可用性和设计的输入和反馈。 HCP还将提供关于依从性跟踪网站设计的意见和反馈。3期患者 将按中心随机分配至新干预或常规护理（对照），并测量其依从性 用电子药盒