sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 4
- 主要终点
- 24-hr urine volume
研究概览
简要总结
The purpose of this study is to examine the feasibility of using sipIT tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended fluid consumption guidelines in participants with a history of urolithiasis.
详细描述
The study uses a randomized controlled trial design with a 12-month intervention period and outcome assessments at baseline, 1, 3, and 12 months. Participants will be randomly assigned to groups. Both groups will receive usual care which involves education about fluid intake guidelines and encouragement to adhere to those guidelines from a clinician. The intervention group will additionally receive the sipIT intervention comprising a semi-automated fluid intake tracking system and context-sensitive, just-in-time notifications reminding them to drink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •previous diagnosis of symptomatic kidney stone in past 5 yrs
- •24-hr urine volume ≤ 2.0 L/day,
- •age 18 or older,
- •own iOS or Android smartphone,
- •proficient in English language,
- •capable of providing informed consent, and
- •willing to use a Fitbit smartwatch, connected water bottle, and mobile app for the study every day for a year, and receive text messages reminder to drink.
排除标准
- •previous diagnosis with cystine stone,
- •pregnant or planning to become pregnant in the next 12 months,
- •concurrently participating in another study involving fluid intake or diet,
- •plan to have surgery or relocate outside the area within the next year
- •co-morbidities that preclude high fluid intake, conditions with high fluid losses (e.g., congestive heart failure, bariatric surgery, GI tract ostomy, short gut syndrome, chronic diarrhea including patients with ulcerative colitis/Crohn's disease, hyponatremia), or conditions that preclude ability to collect 24-hour urine (severe urinary incontinence),
- •active medical treatments that would impair protocol compliance,
- •chronic use of lithium, or
- •psychiatric conditions impairing compliance with the study protocol.
结局指标
主要结局
24-hr urine volume
时间窗: 12 months
Change in urine volume from baseline
次要结局
- Urine supersaturations(1 month, 3 months, and 12 months)
- Habit strength for fluid intake(3 months, and 12 months)
- Past-week fluid intake(3 months, and 12 months)
- 24-hr urine volume(1 month and 3 months)
- Urine supersaturations(1 month, 3 months, and 12 months)
- Habit strength for fluid intake(3 months, and 12 months)
- Past-week fluid intake(3 months, and 12 months)
研究者
David Conroy
Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology
University of Michigan