Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis

Urolithiasis Clinical Trial

Official title:

Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269783
• Other study ID #: STUDY00022968
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Penn State University
• Contact: David E Conroy, PhD
• Phone: 814-863-3451
• Email: dec9[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.

Description:

The study is a six-month ecological momentary assessment study of patients using the mini-sipIT intervention for 3 months, with weekly assessments of motivation and life events or stressors that disrupt routines during the 3-month intervention period, and monthly assessments of motivation and life events or stressors that disrupt routines in the three months following the end of intervention (months 4-6). The mini-sipIT intervention includes automated and manual tracking of fluid intake and lapse-contingent reminders to drink.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous diagnosis of symptomatic kidney stone in the past 5 years,
• Age 18 or older,
• Own an iOS or Android smart phone,
• Proficient in English,
• Capable of providing informed consent,
• Willing to use the water bottle and companion app & receive text message reminders for 3 months,
• Live in continental US.

Exclusion Criteria:

• Pregnant or planning to become pregnant during the next 6 months,
• Concurrently participating in other study involving fluid intake or diet,
• Plan to have surgery in the next 6 months,
• Co-morbidities that preclude high fluid intake (congestive heart failure, end-stage renal disease, chronic hyponatremia), or
• Active medical treatments that would impair protocol compliance.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Urinary Calculi
• Urolithiasis

Intervention

Behavioral:
• sipIT
Automated and manual fluid tracking system with just-in-time reminder messages to support fluid intake habit formation.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine volume (intervention)	Change in urine volume	from baseline to the end of the intervention period (3 months)
Secondary	Urine volume (maintenance)	Change in urine volume	from the end of the intervention period (3 months) to the maintenance change at 6 months