Efficacy of sipIT Intervention for Increasing Urine Output in Patients with Urolithiasis

项目摘要 肾结石影响了估计8.8%的美国成年人，直接医疗费用超过100亿美元 每年。结石的五年复发率高达40%， 预防的方法是增加液体摄入量，每天产生> 2.5 L的尿液。满足这些准则 降低结石复发率50-60%，但患者坚持液体摄入指南通常 低于50%。预防复发的家庭护理包括关于增加液体摄入和饮食的教育。 变化;然而，低依从率表明许多患者将受益于额外的支持 遵守液体摄入指南。这项研究的长期目标是减少疼痛的复发。 和昂贵的结石通过提高病人遵守液体摄入指南（二级预防）。数字 技术提供了增加覆盖面和支持治疗依从性的承诺，但迄今为止， 在用于支持治疗依从性的数字化工具的临床试验中，前景尚未完全实现。中 在一系列的六项初步研究中，我们让患者参与开发和测试一种上下文敏感的数字工具， 称为sipIT，这是一种及时的适应性干预措施，可以促进液体摄入并增加尿液排出量。我们学到 患者愿意使用数字化工具，只要这些工具与他们的生活方式相结合， to the changing变化contexts上下文of their其lives生活.由此产生的干预，sipIT，结合了一种新的半自动化 跟踪系统，以触发智能手机通知与上下文敏感的提醒喝。提醒 系统是由当代的习惯形成理论告知，以支持最终的行为改变， 缺乏技术。在这个应用程序中，我们建议回答问题，“sipIT是否增加24小时 尿量超过常规护理超过3个月？”选择尿量作为近端替代物 终点基于预防肾结石复发的临床指南。具体目标是 项目是（1）评估sipIT与常规护理相比，在有尿量增加病史的患者中的疗效 的肾结石，和（2）确定生物和行为的调节剂的干预影响尿量 （治疗效果的异质性）。我们提出了一个双臂随机对照试验，以实现这些目标。 患者将接受常规护理+ sipIT（干预组）或仅接受常规护理（对照组）。我们将 在基线和第1、3和4天评估24小时尿量、尿过饱和度和液体摄入习惯强度， 干预后12个月。如果成功，这项研究将导致一种具有成本效益的干预措施， 消费者技术，以便在临床实践中进行推广和实施， 石头的负担和成本。它推进了NIDDK预防非癌性泌尿系统疾病的目标， 可以应用于支持其它脱水相关的健康问题（例如，尿路感染，认知 性能、热应激、术后再入院）。

Project Summary Kidney stones affect an estimated 8.8% of American adults and direct medical costs exceed $10 billion annually. Five-year recurrence rates for stones have been as high as 40% and a standard guideline for prevention is to increase fluid intake enough to produce > 2.5 L of urine daily. Meeting these guidelines reduces stone recurrence rates by 50-60% yet patients’ adherence to fluid intake guidelines is commonly below 50%. Usual care for preventing a recurrence involves education about increasing fluid intake and dietary changes; however, the low adherence rate indicates that many patients would benefit from additional support in adhering to fluid intake guidelines. The long-term goal of this research is to reduce the recurrence of painful and costly stones by improving patient adherence to fluid intake guidelines (secondary prevention). Digital technology offers the promise of increasing reach and supporting treatment adherence but, to date, that promise has not been fully realized in clinical trials of digital tools for supporting treatment adherence. In a series of six preliminary studies, we engaged patients in developing and testing a context-sensitive digital tool called sipIT, a just-in-time adaptive intervention to promote fluid intake and increase urine output. We learned that patients are open to using digital tools provided those tools are integrated with their lifestyle and sensitive to the changing contexts of their lives. The resulting intervention, sipIT, incorporates a novel semi-automated tracking system to trigger smartphone notifications with context-sensitive reminders to drink. The reminder system was informed by contemporary theories of habit formation to support behavior change in the eventual absence of the technology. In this application, we propose to answer question, “Does sipIT increase 24-hour urine output more than usual care over a 3-month period?” Urine output was selected as a proximal surrogate endpoint based on clinical guidelines for preventing recurrence of kidney stones. The specific aims of this project are (1) to evaluate the efficacy of sipIT vs usual care for increasing urine output in patients with a history of kidney stones, and (2) to identify biological and behavioral moderators of intervention effects on urine output (heterogeneity of treatment effects). We propose a two-arm randomized controlled trial to achieve these aims. Patients will receive either usual care + sipIT (intervention group) or usual care alone (control group). We will evaluate 24-hour urine output, urine supersaturations, and fluid intake habit strength at baseline and 1, 3, and 12 months after intervention. If successful, this research will lead to a cost-effective intervention that leverages consumer technology so it can be scaled for dissemination and implementation in clinical practice to reduce the burden and cost of stones. It advances NIDDK goals of preventing noncancerous urologic diseases and may be applied to support other dehydration-related health concerns (e.g., urinary tract infections, cognitive performance, heat stress, post-surgical hospital readmissions).