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: 10119792
• 负责人: DAVID E. CONROY
• 金额: $ 65.07万
• 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/10119792
• 关键词: 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; 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; Lead; Life Style; Liquid substance; Manuals; Mediating; Medical Care Costs; Methods; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Negative Reinforcements; Notification; Operative Surgical Procedures; Output; Pain; Patient Monitoring; Patients; Physical activity; Planning Techniques; Prevention; Prevention Guidelines; Randomized; Randomized Controlled Trials; 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; adaptive intervention; adherence rate; application programming interface; arm; base; behavior change; clinical practice; cognitive performance; compliance behavior; cost; cost effective; data exchange; digital; drinking; drinking behavior; effective intervention; efficacy testing; evidence base; financial incentive; fitbit; group intervention; healthy lifestyle; hospital readmission; imaging study; improved; innovation; interest; intervention effect; meetings; mobile application; novel; 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 肾结石影响估计占美国成年人的8.8％，直接医疗费用超过100亿美元 石头的五年复发率高达40％，是标准指南 预防是增加足够的液体摄入量，每天产生> 2.5 L的尿液。符合这些准则 将石头复发率降低了50-60％，但患者遵守流体摄入指南通常是 低于50％。预防复发的通常护理涉及有关增加液体摄入和饮食的教育 变化；但是，较低的依从性率表明许多患者将受益于额外的支持 遵守流体摄入指南。这项研究的长期目标是减少痛苦的复发 通过改善患者遵守液体摄入指南（二级预防），并昂贵的石头。数字的 技术提供了增加覆盖范围和支持治疗依从性的希望，但迄今为止 在支持治疗依从性的数字工具的临床试验中，尚未完全实现Promise。在 系列六项初步研究，我们聘请患者开发和测试上下文敏感的数字工具 称为SIPIT，这是一种恰当的自适应干预措施，可促进液体摄入并增加尿量。我们学会了 患者愿意使用数字工具，只要这些工具与他们的生活方式和敏感 到他们生活中不断变化的环境。由此产生的干预措施sipit结合了一种新型的半自动 跟踪系统以触发智能手机通知，并提醒饮酒。提醒 当代理论的习惯形成理论为支持行为改变而告知系统。 缺乏技术。在此应用程序中，我们建议回答问题：“ SIPIT会增加24小时 在3个月内，尿量比平常的护理多？”尿量被选为近端替代 基于预防肾结石复发的临床指南的终点。这个特定的目的 项目是（1）评估SIPIT与常规护理的效率，以增加病史患者的尿量 肾结石，以及（2）确定干预对尿量影响的生物学和行为主持人 （治疗效果的异质性）。我们提出了一项两臂随机对照试验，以实现这些目标。 患者将单独接受常规护理 + SIPIT（干预组）或通常的护理（对照组）。我们将 评估基线和1、3的24小时尿量，尿液过饱和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，因此可以在临床实践中进行缩放以进行传播和实施以减少 燃烧和石头的成本。它促进了NIDDK的目标，即防止非癌性泌尿科疾病和 可用于支持其他与脱水有关的健康问题（例如，尿路感染，认知能力 性能，热应激，手术后医院再入院）。