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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

基本信息

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
项目类别：
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

项目摘要

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).

项目总结