The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio, United States of America.
The Ohio State University College of Medicine, Columbus, Ohio, United States of America.
PLoS One. 2023 Aug 17;18(8):e0289987. doi: 10.1371/journal.pone.0289987. eCollection 2023.
Medication non-adherence rates in children range between 50% and 80% in the United States. Due to multifaceted outpatient routines, children receiving hematopoietic stem cell transplant (HCT) are at especially high risk of non-adherence, which can be life-threatening. Although digital health interventions have been effective in improving non-adherence in many pediatric conditions, limited research has examined their benefits among families of children receiving HCT. To address this gap, we created the BMT4me© mobile health app, an innovative intervention serving as a "virtual assistant" to send medication-taking reminders for caregivers and to track, in real-time, the child's medication taking, barriers to missed doses, symptoms or side effects, and other notes regarding their child's treatment. In this randomized controlled trial, caregivers will be randomized to either the control (standard of care) group or the intervention (BMT4me© app) group at initial discharge post-HCT. Both groups will receive an electronic adherence monitoring device (i.e., medication event monitoring system "MEMS" cap, Medy Remote Patient Management "MedyRPM" medication adherence box) to store their child's immunosuppressant medication. Caregivers who agree to participate will be asked to complete enrollment, weekly, and monthly parent-proxy measures of their child's medication adherence until the child reaches Day 100 or complete taper from immunosuppression. Caregivers will also participate in a 15 to 30-minute exit interview at the conclusion of the study. Descriptive statistics and correlations will be used to assess phone activity and use behavior over time. Independent samples t-tests will examine the efficacy of the intervention to improve adherence monitoring and reduce readmission rates. The primary expected outcome of this study is that the BMT4me© app will improve the real-time monitoring and medication adherence in children receiving hematopoietic stem cell transplant following discharge, thus improving clinical outcomes.
美国儿童的药物不依从率在 50%至 80%之间。由于多方面的门诊常规，接受造血干细胞移植 (HCT) 的儿童特别容易出现不依从的情况，这可能会危及生命。尽管数字健康干预措施在改善许多儿科疾病的不依从率方面已被证明是有效的，但很少有研究探讨其在接受 HCT 的儿童家庭中的益处。为了解决这一差距，我们创建了 BMT4me©移动健康应用程序，这是一种创新的干预措施，充当“虚拟助手”，为照顾者发送服药提醒，并实时跟踪儿童的服药情况、错过剂量的障碍、症状或副作用以及其他关于其儿童治疗的笔记。在这项随机对照试验中，照顾者将在 HCT 后初始出院时随机分配到对照组（标准护理）或干预组（BMT4me©应用程序）。两组都将收到一个电子依从性监测设备（即药物事件监测系统“MEMS”帽，Medy 远程患者管理“MedyRPM”药物依从性盒）来存放他们孩子的免疫抑制剂药物。同意参与的照顾者将被要求完成登记，每周和每月的父母代理措施，以衡量他们孩子的药物依从性，直到孩子达到第 100 天或从免疫抑制中逐渐减少。在研究结束时，照顾者还将参加一个 15 至 30 分钟的退出访谈。描述性统计和相关性将用于评估随时间推移的手机活动和使用行为。独立样本 t 检验将检查干预措施提高依从性监测和降低再入院率的效果。这项研究的主要预期结果是，BMT4me©应用程序将改善接受造血干细胞移植后出院儿童的实时监测和药物依从性，从而改善临床结果。
