Clinical trial NCT05196113: sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
Official title: sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urolithiasis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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 criteria: 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 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.

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 (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.

Primary outcomes:
measure: 24-hr urine volume
timeFrame: 3 months
Secondary outcomes:
measure: 24-hr urine volume
timeFrame: 1 month and 12 months
measure: Urine supersaturations
timeFrame: 1 month, 3 months, and 12 months
measure: Habit strength for fluid intake
timeFrame: 3 months, and 12 months
measure: Past-week fluid intake
timeFrame: 3 months, and 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: David E Conroy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Necole M Streeper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conroy DE, Marks J, Cutshaw A, Ram N, Thomaz E, Streeper NM. 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.