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sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

  • 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 wear a Fitbit smartwatch daily for 1 year.

Exclusion Criteria:

  • 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 (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.

Study details

Urolithiasis

NCT05196113

Penn State University

25 January 2024

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