Improving adherence through mHealth for pediatric hematopoietic stem cell transplant patients

项目总结/摘要 据估计，50 - 80%的儿科患者不依从。3 - 6广泛的儿科依从性研究 存在于实体器官移植、囊性纤维化、糖尿病和其他慢性疾病中。然而，只有 三项已知的HSCT儿童研究均报告了次优依从率（52 - 78%）， 7 - 9此外，在试点研究中，70%的HSCT提供者报告依从性是主要关注的问题， 10目前，没有HSCT特异性干预措施可以改善 依从性和临床结果。迫切需要评估新的移动健康方法，以改善 在接受造血干细胞移植（HSCT）的儿童中， 预防发病和死亡。理由是，一个mHealth应用程序，旨在发送药物提醒， 护理人员将增加对免疫抑制剂药物的依从性，从而潜在地减少GVHD， 再入院和死亡率。该应用程序还将获取不遵守的原因，以增加我们对以下内容的了解 在这一人群中坚持的障碍。此K99/R00应用程序描述了以下方面的背景和经验： 申请人Micah A. Skeens博士，注册护士，她计划获得必要的知识和培训， 成为依从性和移动健康干预方面领先的独立临床研究者， 造血干细胞移植（HSCT）的临床结果。期间的总体目标 K99将获得移动健康干预措施、依从性和进行随机 对照试验（RCT），以开发和测试mHealth应用程序，用于儿科HSCT患者的依从性， 移植后的急性期使用行为经济学的方法，这个新的移动健康的目标 应用将是为了提高依从性和最终的临床结果，以及收集信息 关于障碍。在K99阶段的研究具体目标是开发一个坚持mHealth 应用程序使用混合方法的方法，并评估的可用性和可接受性的mHealth 应用于移植后急性门诊期的儿科HSCT患者。迎接K99培训 为了实现这些目标，与国际公认的 由资深研究专家组成的跨学科导师团队。R00阶段的总体目标是 进行一项有40名护理人员参加的试验性随机对照试验，以评估新的 R00阶段的研究具体目标是：1）评估可接受性 一个新开发的移动健康应用程序的可行性，以及在该系统中招募和保留40名儿童照顾者的可行性。 HSCT后的急性门诊期和2）评估mHealth应用程序对遵守 HSCT后急性期出院回家的儿童的免疫抑制剂。的 结果将直接支持R-01申请，以进行mHealth的多地点RCT疗效试验 应用于HSCT后急性期儿童的依从性和临床结局。

PROJECT SUMMARY/ABSTRACT An estimated 50-80% of all pediatric patients are non-adherent.3-6 Extensive pediatric adherence research exists in solid organ transplant, cystic fibrosis, diabetes, and other chronic illnesses. However, there are only three known studies in children with HSCT, and all report suboptimal adherence rates (52-78%) that worsen over time.7-9 Additionally, in pilot study, 70% of HSCT providers reported adherence as a major concern for their outpatient pediatric HSCT recipients.10 Currently, no HSCT specific interventions exist to improve adherence and clinical outcomes. There is a critical need to evaluate novel mHealth approaches to improve adherence and clinical outcomes among children receiving hematopoietic stem cell transplant (HSCT) to prevent morbidity and mortality. The rationale is that a mHealth app designed to send medication reminders to caregivers will increase adherence to immunosuppressant medication, thereby potentially reducing GVHD, readmissions, and mortality. The app will also obtain reasons for non-adherence adding to our knowledge of barriers to adherence in this population. This K99/R00 application describes the background and experience of the applicant, Micah A. Skeens PhD, RN, and her plan to acquire the knowledge and training necessary to become a leading independent clinical investigator in adherence and mHealth interventions that improve clinical outcomes for children undergoing hematopoietic stem cell transplant (HSCT). The overall goal during the K99 is to gain advanced research training in mHealth interventions, adherence and conducting randomized controlled trials (RCTs) to develop and test a mHealth application for adherence of pediatric HSCT patients in the acute phase post-transplant. Using a behavioral economics approach, the goal of this new mHealth application will be to improve adherence and ultimately clinical outcomes as well as collect information regarding barriers. The research specific aim during the K99 phase is to develop an adherence mHealth application using a mixed methods approach and to evaluate the usability and acceptability of the mHealth application for pediatric HSCT patients in the acute outpatient phase post-transplant. To meet the K99 training objectives, a comprehensive training plan has been developed in concert with an internationally recognized interdisciplinary mentorship team of senior research experts. The overall goal during the R00 phase is to conduct a pilot RCT with 40 caregivers to assess acceptability, feasibility and potential efficacy of the newly developed mHealth app. The research specific aims during the R00 phase are to: 1) evaluate the acceptability of a newly developed mHealth app and the feasibility of enrolling and retaining 40 caregivers of children in the acute outpatient phase post-HSCT and 2) evaluate the potential efficacy of the mHealth app on adherence to immunosuppressants in children who have been discharged home during the acute phase post-HSCT. The results will directly support an R-01 application to conduct a multi-site RCT efficacy trial of the mHealth application on adherence and clinical outcomes in children during the acute phase post-HSCT.