Promoting fluid intake to increase urine volume for kidney stone prevention: Protocol for a randomized controlled efficacy trial of the sipIT intervention

Contemp Clin Trials. 2024 Mar:138:107454. doi: 10.1016/j.cct.2024.107454. Epub 2024 Jan 20.

Abstract

Background: Risk of kidney stone recurrence can be reduced by increasing fluid intake and urine production but most patients fail to adhere to recommended clinical guidelines. Patients have indicated that common barriers to fluid intake include a lack of thirst, forgetting to drink, and not having access to water. We developed the sipIT intervention to support patients' fluid intake with semi-automated tracking (via a mobile app, connected water bottle and a smartwatch clockface that detects drinking gestures) and provision of just-in-time text message reminders to drink when they do not meet the hourly fluid intake goal needed to achieve the recommended volume. This trial evaluates the efficacy of sipIT for increasing urine output in patients at risk for recurrence of kidney stones.

Method/design: Adults with a history of kidney stones and lab-verified low urine production (<2 L/day) will be randomly assigned to receive either usual care (education and encouragement to meet fluid intake guidelines) or usual care plus the sipIT intervention. The primary outcome is 24-h urine volume; secondary outcomes include urinary supersaturations, past week fluid intake, and experienced automaticity of fluid intake. Outcomes will be assessed at baseline, 1 month, 3 months, and 12 months.

Conclusions: The sipIT intervention is the first to prompt periodic fluid intake through integration of just-in-time notifications and semi-automated tracking. If sipIT is more efficacious than usual care, this intervention provides an innovative treatment option for patients needing support in meeting fluid intake guidelines for kidney stone prevention.

Keywords: Behavioral intervention; Hydration; Mobile health; Prevention; Urology.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Drinking
  • Humans
  • Kidney
  • Kidney Calculi* / prevention & control
  • Mobile Applications*
  • Randomized Controlled Trials as Topic