sipIT Intervention for Kidney Stones

No longer recruiting at 2 trial locations

Overseen By Alyssa Cutshaw, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Lithium

Disqualifiers: Pregnancy, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how digital tools like wrist-worn sensors, smart water bottles, and mobile apps can help people follow their doctor's advice on fluid intake to prevent kidney stones. Participants will either use these digital tools to track and remind them about their fluid intake or receive standard guidance without the digital tools. The trial seeks individuals who have had a kidney stone in the past five years and can use a smartphone, smartwatch, and connected water bottle daily for a year. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance kidney stone prevention strategies.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic lithium treatment, you cannot participate in the study.

What prior data suggests that the sipIT tools are safe for increasing fluid intake compliance?

Research has shown that the sipIT program, which uses wrist-worn sensors, smart water bottles, and mobile apps, helps people drink more water to prevent kidney stones. Studies have found this method effective for patients, leading to a significant increase in daily urine production, which is crucial for reducing the risk of kidney stones. Notably, no problems or safety issues have been reported with these tools, suggesting that participants find the sipIT program easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The sipIT intervention is unique because it combines education with a digital tool to actively monitor and encourage fluid intake, which is crucial for preventing kidney stones. Unlike standard care, which typically involves just verbal advice and encouragement, this approach uses technology to provide real-time reminders and track hydration habits. Researchers are excited about this trial as it could lead to more effective prevention of kidney stones by promoting consistent and adequate fluid intake in a personalized way.

What evidence suggests that the sipIT intervention is effective for increasing fluid intake in individuals with a history of kidney stones?

Research has shown that the sipIT tool, which participants in this trial may receive, can help people increase fluid intake, crucial for those with a history of kidney stones. Studies have found that producing over 2.5 liters of urine daily can reduce the risk of kidney stones returning by 50% to 60%. The sipIT system, which includes smart tools like wrist sensors and apps, successfully encouraged most people to drink more fluids over three months. This increased fluid intake lowers the chance of kidney stones recurring. Therefore, using the sipIT tool might effectively help prevent kidney stones from returning. ^{2 3 4 6 7}

Who Is on the Research Team?

David E Conroy, PhD

Principal Investigator

University of Michigan

Necole M Streeper, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who've had a kidney stone in the last 5 years, can use a smartphone, and are willing to wear a Fitbit daily for a year. They should drink less than 2 liters of fluid per day. It's not for pregnant women or those planning pregnancy, people moving away or having surgery soon, on certain medical treatments, with specific health conditions that affect fluid intake or urine collection.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I have had a painful kidney stone in the last 5 years.

Own iOS or Android smartphone

Exclusion Criteria

Pregnant or planning to become pregnant in the next 12 months

I have been diagnosed with cystine kidney stones before.

Concurrently participating in another study involving fluid intake or diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' fluid intake and urine volume

1 visit

Intervention

Participants receive education and, if in the experimental group, a digital tool to monitor fluid intake

12 months

Visits at 1, 3, and 12 months

Follow-up

Participants are monitored for changes in urine volume and fluid intake habits

12 months

Outcome assessments at 1, 3, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• sipIT

Trial Overview The sipIT study tests if tools like wrist sensors, smart water bottles, and apps can help people with past kidney stones follow doctor's advice on drinking enough fluids. Participants will use these tech aids to see if they improve their hydration habits.

How Is the Trial Designed?

Group I: sipIT Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A combined nutritional and medical therapy approach significantly improved urinary risk factors for stone disease in 137 patients over an average follow-up of 14.39 months, with notable improvements in hypocitraturia (67% of patients), hypercalciuria (82%), and hyperuricosuria (72%).

The study highlights that individualized medical management based on specific urinary abnormalities can effectively reduce stone risk, especially for patients who do not respond to dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered medical therapy for nephrolithiasis. Marchini, GS., Ortiz-Alvarado, O., Miyaoka, R., et al.[2013]

Potassium citrate therapy significantly reduced new stone formation in patients with mild to moderately severe stone disease, achieving a remission rate of 96% (from 0.52 to 0.02 stones per patient per year, p < 0.001).

In contrast, conservative measures or placebo trials only decreased new stone formation by 54% (from 0.54 to 0.25 stones per patient per year), indicating that potassium citrate provides a more effective treatment beyond standard conservative approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of "specific" potassium citrate therapy versus conservative management in nephrolithiasis of mild to moderate severity. Preminger, GM., Harvey, JA., Pak, CY.[2019]

In a study of 242 patients with calcium-containing kidney stones, those who received specific dietary therapy tailored to their metabolic needs had a significantly lower recurrence rate of stones (6%) compared to those who followed general dietary advice (19%).

The results suggest that personalized dietary counseling is crucial for preventing future kidney stones, highlighting the importance of tailored interventions over generic recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of nonmedical prophylaxis after a first kidney stone. Kocvara, R., Plasgura, P., Petrík, A., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38253254/

Promoting fluid intake to increase urine volume for kidney ... This trial evaluates the efficacy of sip IT for increasing urine output in patients at risk for recurrence of kidney stones.

2. reporter.nih.gov reporter.nih.gov/project-details/10893454

Efficacy of sipIT Intervention for Increasing Urine Output in ... Five-year recurrence rates for stones have been as high as 40% and a standard guideline for prevention is to increase fluid intake enough to produce > 2.5 L of ...

3. medicalupdate.pennstatehealth.org medicalupdate.pennstatehealth.org/urology-surgery/hydration-increase-research-0824/

Researchers Test Technological Intervention to Increase ... The system proved successful with a majority of participants in a three-month feasibility study. The research brings hope for helping patients make long-term ...

4. auanews.net auanews.net/issues/articles/2023/october-extra-2023/clinical-trials-sipit-behavioral-intervention-clinical-trial-to-increase-fluid-intake-for-kidney-stone-prevention

CLINICAL TRIALS SipIT Behavioral Intervention ... Kidney stone prevalence continues to rise but producing 2.5 L of urine daily is associated with a 50%-60% decreased risk of stone recurrence.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429523005630

Feasibility of Mini sipIT Behavioral Intervention to Increase ... This trial evaluates the efficacy of sipIT for increasing urine output in patients at risk for recurrence of kidney stones.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11166357/

Feasibility of mini sipIT Behavioral Intervention to Increase ... Mini sip IT behavioral intervention and outcome assessments are feasible for patients and may lead to significant increases in 24-hour urine volume.

7. users.ece.utexas.edu users.ece.utexas.edu/~ethomaz/papers/j23.pdf

Protocol for a randomized controlled efficacy trial The primary outcome analysis will evaluate the efficacy of sipIT vs usual care for increasing urine volume in patients with a history of kidney ...