Urolithiasis
Conditions
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.
Interventions
BEHAVIORALsipIT
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hr urine volume | 12 months | Change in urine volume from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hr urine volume | 1 month and 3 months | Change in urine volume from baseline |
| Urine supersaturations | 1 month, 3 months, and 12 months | Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months |
| Habit strength for fluid intake | 3 months, and 12 months | Change in habit by the 4-item Self-Report Behavioural Automaticity Index (Gardner, Abraham, Lally & de Bruijn, 2012, Int J Beh Nutr Phys Act; baseline to 3/12 months). Responses will be averaged so scores range from 1 (strongly disagree) to 7 (strongly agree) with higher scores indicating stronger habits for fluid intake. |
| Past-week fluid intake | 3 months, and 12 months | Change in past-week volume of fluid intake from baseline to 3/12 months |
Countries
United States
Outcome results
None listed