Improving adherence through mHealth for pediatric hematopoietic stem cell transplant patients

通过移动医疗提高儿科造血干细胞移植患者的依从性

• 批准号: 10594233
• 负责人: Micah Skeens
• 金额: $ 24.9万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-24 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10594233
• 关键词: Acute; Address; Adherence; Age; Biological Assay; Care given by nurses; Caregivers; Caring; Child; Child Care; Childhood; Chronic Disease; Clinical; Clinical Investigator; Cystic Fibrosis; Development; Diabetes Mellitus; Doctor of Philosophy; Education; Enrollment; Family; Frequencies; Goals; Health Care Costs; Hematopoietic Stem Cell Transplantation; Home; Hospitalization; Immunosuppression; Immunosuppressive Agents; International; Intervention; Interview; Knowledge; Measures; Mediator of activation protein; Mentorship; Methods; Mobile Health Application; Morbidity - disease rate; Nurses; Organ Transplantation; Outcome; Outpatients; Participant; Patient Noncompliance; Patient Self-Report; Patients; Pediatrics; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Positioning Attribute; Process; Provider; Randomized; Randomized Controlled Trials; Reporting; Research; Research Personnel; Research Training; Science; Scientist; Serum; Site; Socioeconomic Status; Solid; Structure; Technology; Testing; Time; Training; Transplant Recipients; Treatment Protocols; United States; Work; adherence rate; base; behavior change; behavioral economics; design; efficacy evaluation; efficacy trial; experience; formative assessment; graft vs host disease; hospital readmission; improved; improved outcome; indexing; innovation; mHealth; mortality; novel; pediatric patients; post-transplant; prevent; primary outcome; programs; secondary outcome; sex; successful intervention; systematic review; therapy development; treatment as usual; treatment duration; universal prevention; usability

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.

项目摘要/摘要 估计所有儿科患者中有50-80％是不遵守的。3-6广泛的儿科依从性研究 存在于固体器官移植，囊性纤维化，糖尿病和其他慢性病中。但是，只有 对HSCT儿童的三项已知研究以及所有报告次优率（52-78％）的研究恶化 随着时间的流逝，7-9此外，在试点研究中，有70％ 他们的门诊儿科HSCT接受者。10当前，没有HSCT特定的干预措施来改进 依从性和临床结果。评估新颖的MHealth方法以改进的迫切需要 接受造血干细胞移植（HSCT）的儿童的依从性和临床结果 防止发病率和死亡率。理由是一个旨在将药物提醒发送给的MHealth应用程序 护理人员将增加对免疫抑制剂药物的依从性，从而有可能减少GVHD， 再入院和死亡率。该应用程序还将获得不遵守的原因，以增加我们对 遵守该人群的障碍。此K99/R00应用程序描述了 申请人Micah A. Skeens PhD，RN及其计划获得必要的知识和培训的计划 成为依从性和MHealth干预措施的领先独立临床研究者 接受造血干细胞移植（HSCT）儿童的临床结局。总体目标 K99将获得MHealth干预，遵守和进行随机进行的高级研究培训 对照试验（RCT）开发和测试MHealth遵守儿科HSCT患者的MHealth申请 移植后急性期。使用行为经济学方法，这是这种新MHealth的目标 应用将是提高依从性并最终临床结果，并收集信息 关于障碍。 K99阶段的研究特定目的是开发依从性MHealth 使用混合方法的应用并评估MHealth的可用性和可接受性 在移植后急性门诊期间针对小儿HSCT患者的申请。遇到K99培训 目标是与国际认可的一致的全面培训计划 高级研究专家的跨学科指导团队。 R00阶段的总体目标是 与40名护理人员进行飞行员RCT，以评估新近的可接受性，可行性和潜在疗效 开发的MHealth应用程序。 R00阶段的研究特定目的是：1）评估可接受性 一个新开发的MHealth应用程序以及在该应用程序中注册和留住40名儿童护理人员的可行性 HSCT后急性门诊阶段和2）评估MHealth应用程序对遵守的潜在功效 HSCT急性期在急性期出院的儿童中的免疫抑制剂。这 结果将直接支持R-01申请，以进行MHealth的多站点RCT疗效试验 HSCT急性期急性期儿童的依从性和临床结局的应用。