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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-04

Study Completion Date

2025-04-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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sipIT

Participants receive education and a digital tool to monitor their fluid intake and remind them when they have lapsed in regular fluid intake.

Group Type EXPERIMENTAL

sipIT

Intervention Type BEHAVIORAL

Participants receive education and digital tools to monitor their fluid intake and just-in-time text messages to remind them when they have lapsed in regular fluid intake.

Control

Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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sipIT

Participants receive education and digital tools to monitor their fluid intake and just-in-time text messages to remind them when they have lapsed in regular fluid intake.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes