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

sipIT 干预对增加尿石症患者尿量的疗效

• 批准号: 10679033
• 负责人: DAVID E. CONROY
• 金额: $ 59.72万
• 依托单位: PENNSYLVANIA STATE UNIVERSITY, THE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10679033
• 关键词: 2 arm randomized control trial; Adherence; Adult; Affect; Age; Algorithms; American; Behavior; Behavior Therapy; Behavioral; Behavioral Sciences; Biologic Characteristic; Biological; Cellular Phone; Clinical; Clinical Trials; Companions; Complement; Consumption; Control Groups; Cues; Custom; Dehydration; Detection; Diet; Disease; Dissemination and Implementation; Education; Emergency department visit; Focus Groups; Frequencies; Funding; Gestures; Goals; Guidelines; Habits; Health; Health behavior change; Heat Stress Disorders; Heterogeneity; Hour; Hydration status; Intake; Intervention; Kidney Calculi; Learning; Life Style; Liquid substance; Manuals; Mediating; Medical Care Costs; Methods; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Negative Reinforcements; Notification; Output; Pain; Patient Monitoring; Patients; Physical activity; Prevention; Prevention Guidelines; Randomized; Recording of previous events; Recurrence; Reminder Systems; Research; Salts; Secondary Prevention; Series; Services; Shapes; Surrogate Endpoint; Surveys; System; Techniques; Technology; Testing; Time; Urinary Calculi; Urinary tract infection; Urine; Urologic Diseases; Water; acceptability and feasibility; adaptive intervention; adherence rate; application programming interface; behavior change; clinical practice; cognitive performance; compliance behavior; cost; cost effective intervention; data exchange; dietary; digital technology; digital tool; drinking; drinking behavior; efficacy evaluation; efficacy testing; evidence base; financial incentive; fitbit; group intervention; healthy lifestyle; hospital readmission; imaging study; improved; innovation; interest; intervention effect; meetings; mobile application; novel; patient engagement; prevent; secondary outcome; sensor; sex; smart watch; smartphone application; support tools; theories; tool; treatment adherence; treatment as usual; treatment effect; treatment response; urolithiasis; wearable device

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).

项目摘要 据估计，8.8%的美国成年人患有肾结石，直接医疗费用超过100亿美元 每年一次。结石的五年复发率高达40%，这是治疗结石的标准指南 预防措施是增加液体摄入量，使其足以每天产生2.5 L的尿液。符合这些指导原则 将结石复发率降低50%-60%，但患者通常遵守液体摄入指南 低于50%。预防复发的常规护理包括关于增加液体摄入量和饮食的教育 变化；然而，低依从率表明许多患者将从额外的支持中受益 在坚持液体摄入指南方面。这项研究的长期目标是减少疼痛的复发 通过提高患者对液体摄入指南的依从性(二级预防)，减少昂贵的结石。数位 技术提供了增加覆盖面和支持治疗依从性的承诺，但到目前为止， 在支持治疗依从性的数字工具的临床试验中，承诺尚未完全实现。在一个 一系列的六项初步研究，我们让患者开发和测试一个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，旨在促进液体摄取和增加尿量。我们了解到 患者对使用数字工具持开放态度，前提是这些工具与他们的生活方式和敏感性相结合 以适应他们不断变化的生活环境。由此产生的干预，siPIT，结合了一种新型的半自动 跟踪系统可以触发智能手机通知，并根据上下文提示饮酒。提醒： 系统被当代的习惯形成理论所启发，以支持最终的行为改变 缺乏这项技术。在此应用程序中，我们建议回答以下问题：SIPIT是否增加24小时 在3个月的时间里排出的尿量比平时护理的多吗？尿量被选为近端代用品 终点根据防止肾结石复发的临床指南。这样做的具体目的是 项目是：(1)评估有病史的患者接受sipit治疗与常规护理相比增加尿量的效果。 以及(2)确定干预尿量的生物和行为调节因素 (治疗效果的异质性)。为了达到这些目的，我们提出了一个双臂随机对照试验。 患者将接受常规护理+siPIT(干预组)或仅接受常规护理(对照组)。我们会 评估24小时尿量、尿液过饱和度和液体摄入习惯强度在基线和1、3和 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，以便它可以扩展以在临床实践中传播和实施，以减少 石头的负担和成本。它促进了NIDDK预防非癌症泌尿系统疾病和 可用于支持其他与脱水相关的健康问题(例如，尿路感染、认知 表现、热应激、术后再入院)。