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: 10621265
• 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/10621265
• 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 acquisition; Measures; Mediator; 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; 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 据估计，50%-80%的儿科患者没有依从性。3-6项广泛的儿科依从性研究 存在于固体器官移植、囊性纤维化、糖尿病等慢性疾病中。然而，只有 已知的三项关于HSCT儿童的研究，都报告了恶化的次优依从率(52-78%) 随着时间的推移。7-9此外，在试点研究中，70%的HSCT提供者报告遵从性是 他们的门诊儿童造血干细胞移植患者。10目前，没有针对造血干细胞移植的特定干预措施来改善 依从性和临床结果。迫切需要评估新的mHealth方法以改进 接受造血干细胞移植(HSCT)的儿童依从性和临床结局 预防发病率和死亡率。其基本原理是，一款旨在向 照顾者将增加对免疫抑制药物的依从性，从而潜在地减少GVHD， 再入院和死亡率。该应用程序还将获得不遵守的原因，以增加我们对 在这群人中存在坚持的障碍。此K99/R00应用程序描述以下背景和体验 申请者，Micah A.Skeens博士，RN，以及她获得必要的知识和培训的计划 成为遵守和改善mHealth干预措施的领先独立临床研究人员 儿童接受造血干细胞移植(HSCT)的临床结果。期间的总体目标 K99将在移动健康干预、遵守和进行随机试验方面获得高级研究培训 开发和测试mHealth应用程序对儿童HSCT患者依从性的对照试验 移植后急性期。使用行为经济学的方法，这种新的移动健康的目标是 应用程序将改善依从性，并最终获得临床结果以及收集信息 关于障碍。K99阶段的研究特定目标是开发一种坚持性的mHealth 使用混合方法的应用程序以及评估mHealth的可用性和可接受性 儿童造血干细胞移植在急性门诊期移植后的应用。迎接K99培训 为了实现这些目标，制定了一个全面的培训计划，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 与40名照顾者进行一项试验性随机对照试验，以评估新的 开发了mHealth应用程序。R00阶段研究的具体目标是：1)评估可接受性 一款新开发的mHealth应用程序，以及招募和保留40名儿童照顾者在 HSCT后急性门诊阶段和2)评估mHealth应用程序在遵守以下方面的潜在疗效 HSCT后急性期出院儿童的免疫抑制药。这个 结果将直接支持R-01应用程序进行mHealth的多站点RCT疗效试验 儿童造血干细胞移植后急性期依从性及临床结局的应用。