Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.
Children's Healthcare of Atlanta, Atlanta, GA, USA.
BMC Nephrol. 2020 Apr 9;21(1):125. doi: 10.1186/s12882-020-01778-w.
Idiopathic nephrotic syndrome has a relapsing-remitting course in the majority of pediatric patients, demanding vigilant monitoring and self-management. A novel, expert-designed, user-informed mobile application (app), UrApp©, was created to support management tasks, including home urine protein monitoring.
The UrApp Pilot Study (ClinicalTrials.gov, NCT04075656) is a randomized trial comparing UrApp-supported nephrotic syndrome management with standard-of-care with parallel process evaluation of the intervention delivery. Sixty caregivers of children with newly diagnosed, steroid-sensitive nephrotic syndrome will be randomized 1:1 to UrApp-supported care or standard-of-care. Follow-up will be 1 year, with primary outcomes of adherence to urine monitoring and medications assessed at 6 and 12 months. Secondary outcomes at 6 and 12 months include self-efficacy, quality-of-life, hospitalizations and delayed relapse diagnoses. A mixed-methods approach will evaluate UrApp engagement, use retention, features used, user perceptions, and contextual barriers and facilitators of UrApp use. User behavior will be assessed for relationships to the primary and secondary outcomes. A Stakeholder Committee of volunteer trial participants, clinicians, and engineers will examine the trial results and design a pragmatic UrApp-enhanced nephrotic syndrome intervention with potential for wide implementation. The final UrApp intervention will be tested in a user-centered hybrid effectiveness-implementation trial designed with stakeholder input.
The UrApp Pilot Study examines the efficacy of a novel app designed specifically for nephrotic syndrome. The protocol involves dual efficacy and process evaluation aims to increase efficiency and incorporates the stakeholders' perspective in formative assessment to inform intervention redesign and the design of a future user-centered trial.
ClinicalTrials.gov, NCT04075656. Registered on September 2, 2019, https://clinicaltrials.gov/ct2/show/NCT04075656.
大多数儿科患者的特发性肾病综合征呈复发-缓解过程，需要警惕监测和自我管理。为了支持管理任务，包括家庭尿液蛋白监测，我们创建了一个新颖的、专家设计的、用户知情的移动应用程序（app），即 UrApp©。
UrApp 试点研究（ClinicalTrials.gov，NCT04075656）是一项随机试验，比较了 UrApp 支持的肾病综合征管理与标准护理，并对干预措施的传递进行了平行过程评估。将 60 名新诊断为类固醇敏感型肾病综合征的儿童的照顾者随机分为 1:1 接受 UrApp 支持的护理或标准护理。随访时间为 1 年，主要结局是在 6 个月和 12 个月时评估尿液监测和药物的依从性。次要结局在 6 个月和 12 个月时包括自我效能、生活质量、住院和延迟复发诊断。混合方法将评估 UrApp 的参与度、使用保留率、使用的功能、用户感知以及 UrApp 使用的情境障碍和促进因素。将评估用户行为与主要和次要结局的关系。一个由志愿试验参与者、临床医生和工程师组成的利益相关者委员会将检查试验结果，并设计一个具有广泛实施潜力的实用 UrApp 增强型肾病综合征干预措施。最终的 UrApp 干预措施将在一项具有利益相关者投入的以用户为中心的混合有效性实施试验中进行测试。
UrApp 试点研究检验了专门为肾病综合征设计的新型应用程序的疗效。该方案涉及双重疗效和过程评估，旨在提高效率，并在形成性评估中纳入利益相关者的观点，为干预措施的重新设计和未来以用户为中心的试验设计提供信息。
ClinicalTrials.gov，NCT04075656。于 2019 年 9 月 2 日注册，https://clinicaltrials.gov/ct2/show/NCT04075656。
