A Novel Mobile Application for Childhood Nephrotic Syndrome Management

项目摘要/摘要 该建议是一项多学科研究和培训计划，旨在严格评估和提炼以用户为中心的 移动应用程序(APP)用于儿童肾病综合征的管理，并使申请者家世 在肾脏疾病干预方面获得独立研究生涯所需的技能 制定和实施。研究提案的总体目标是提高自我 儿童肾病综合征--最常见的慢性肾脏疾病之一的治疗和临床结果 儿童的疾病。在大多数患者中，该病的特点是复发-缓解模式 并发症发生率高，治疗副作用大。警惕的家庭护理是疾病的核心 然而，许多家庭发现很难坚持这些要求。我们的跨学科团队已经建立了 一款帮助家庭自我管理的新型移动应用程序(UrApp)。UrApp具有出色的技术有效性和 在初步的可用性测试中受到了用户的好评。在这项建议中，我们将进行随机试点 在三个儿科地点对新诊断的肾病综合征儿童照顾者进行的试验评估 UrApp在改善行为和生物学结果方面的有效性(目标1)。同时，我们将表演 过程评估，以确定对UrApp有效性的影响(目标2)。最后，我们将与 护理人员利益相关者使用临床试验和过程评估的结果来改进UrApp并计划 未来以用户为中心的全面临床试验(目标3)。预期的结果是一部小说的发展， 务实的、基于技术的干预，准备在以用户为中心的临床试验中进行全面测试。这 申请者特殊的研究环境使这一提议成为可能。埃默里儿科分部 肾病学是美国最大的儿科肾病项目之一，有许多成功的、广泛的 与其他儿科机构进行研究合作，确保当前提案的可行性。一个坚强的人 埃默里大学、亚特兰大儿童保健和佐治亚理工学院结成联盟 支持UrApp的开发，并在临床试验研究、行为方面提供多学科指导 科学、实施科学和生物统计学。导师制，以及埃默里大学提供的课程， 将为申请者提供特殊的培训。此外，研究活动将为王家石提供 在定性研究、混合方法分析、过程评估方法论和 利益相关者参与方法。这些新技能将增强申请者的临床背景 实践、临床试验研究和定量研究，具有行为和实施方面的专业知识 科学。因此，这项提案的成功完成将为王家石提供一个独特的 使独立的研究事业成为可能并产生第一批循证疾病之一的技能 儿童肾病综合征人群的管理工具。

Project Summary/Abstract This proposal is a multidisciplinary research and training plan to rigorously evaluate and refine a user-centered mobile application (app) for childhood nephrotic syndrome management and enable the applicant, Chia-shi Wang, to obtain the skills needed for an independent research career in kidney disease intervention development and implementation. The broad objectives of the research proposal are to improve self- management and clinical outcomes of childhood nephrotic syndrome, one of the most common chronic kidney diseases in children. The disease is characterized by a relapsing-remitting pattern in the majority of patients and has high rates of complications and treatment side effects. Vigilant home care is central to disease management, yet many families find it difficult to adhere with the demands. Our interdisciplinary team has built a novel mobile app (UrApp) to assist families with self-management. UrApp has excellent technical validity and was well-received by users in preliminary usability testing. In this proposal, we will conduct a pilot randomized trial in three pediatric sites among caregivers of children with newly diagnosed nephrotic syndrome to evaluate the efficacy of UrApp in improving behavioral and biologic outcomes (Aim 1). Concurrently, we will perform process evaluation to determine influences on the effectiveness of UrApp (Aim 2). Lastly, we will engage caregiver stakeholders to use the results of the clinical trial and process evaluation to refine UrApp and plan a future user-centered, full-scale clinical trial (Aim 3). The anticipated outcome is the development of a novel, pragmatic, technology-based intervention that is ready for full-scale testing in a user-centered clinical trial. This proposal is made possible by the applicant’s exceptional research environment. Emory’s Division of Pediatric Nephrology is one of the largest pediatric nephrology programs in the U.S. with many successful, extensive research collaborations with other pediatric institutions, ensuring the feasibility of the current proposal. A strong alliance between Emory University, Children’s Healthcare of Atlanta, and Georgia Institute of Technology enabled the developed of UrApp and provides multidisciplinary mentorship in clinical trial research, behavior science, implementation science, and biostatistics. The mentorship, along with the courses available at Emory, will provide exceptional training for the applicant. In addition, the research activities will provide Chia-shi Wang with hands-on training in qualitative research, mixed-methods analysis, process evaluation methodology, and stakeholder engagement methodology. These new skills will augment the applicant’s background in clinical practice, clinical trials research, and quantitative research with expertise in behavioral and implementation sciences. The successful completion of the proposal will therefore provide Chia-shi Wang with a distinctive skillset to enable an independent research career and produce one of the first evidence-based disease management tools for the childhood nephrotic syndrome population.