sipIT for Kidney Stones

Overseen By Shiyu Li, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Pregnancy, Surgery, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

155 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how a system that tracks fluid intake and sends reminders can help patients change and maintain their drinking habits, especially when their routines are disrupted by stress or life events.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on active medical treatments that would make it hard to follow the study rules, you might not be eligible to participate.

Is sipIT safe for humans?

The research does not provide specific safety data for sipIT, but it mentions the tolerability of Potassium Citrate tablets in patients with kidney stones, suggesting it is generally safe for those who cannot tolerate the powder form. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals who are currently experiencing kidney stones. The specific eligibility criteria to participate in the study have not been provided, so it's important to contact the research team for detailed information on who can join.

Inclusion Criteria

Live in continental US

Proficient in English

I am willing to use a water bottle and app, and get text reminders for 3 months.

Exclusion Criteria

I do not have heart failure, severe kidney disease, or chronic low sodium that would stop me from drinking a lot of fluids.

I am planning to undergo surgery within the next 6 months.

Pregnant or planning to become pregnant during the next 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the mini-sipIT intervention for 3 months, with weekly assessments of motivation and life events or stressors

3 months

Weekly assessments (virtual)

Maintenance

Monthly assessments of motivation and life events or stressors in the three months following the end of intervention

3 months

Monthly assessments (virtual)

Follow-up

Participants are monitored for changes in urine volume from the end of the intervention period to the maintenance change at 6 months

3 months

Treatment Details

Interventions

• sipIT

Trial Overview The sipIT intervention is being tested in this study. It aims to understand how behavior changes, continues over time, and adherence are influenced during and after a three-month period of using sipIT.

Participant Groups

Group I: sipIT Experimental Treatment 1 Intervention

Participants will receive an educational handout about physical activity, a connected water bottle with its companion mobile application. For months 1-3, participants will receive lapse-contingent reminders to drink delivered by text message.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Physiologic effect of nifedipine and tamsulosin on contractility of distal ureter. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Characterizing ceftriaxone-induced urolithiasis and its associated acute kidney injury: an animal study and Chinese clinical systematic review. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Acute kidney injury caused by ceftriaxone-induced urolithiasis in children: a single-institutional experience in diagnosis, treatment and follow-up. [2021]

4. Iran pubmed.ncbi.nlm.nih.gov

The tolerability of Potassium Citrate Tablet in patients with intolerance to Potassium Citrate Powder form. [2020]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Acute kidney injury in Ureteric Stones:Single centre short term analysis. [2020]