Efficacy of sipIT Intervention for Increasing Urine Output in Patients with Urolithiasis

Principal Investigators David E. Conroy (Email), U-M and Necole Streeper (Medical College of Wisconsin)

 

R01 DK124469
NIH Reporter listing
ClinicalTrials.gov registration 

 

Secondary prevention of kidney stones is a major challenge for patients with urolithiasis. Increasing fluid intake to produce a urine output greater than 2.5 L/day is at the core of prevention guidelines from the American Urological Association. Patients are widely aware of the guidelines; however, less than 50% of patients adhere to those guidelines commonly due to lack of thirst or forgetting to drink. Usual care involves educating patients about increasing fluid intake, dietary modification, as well as periodically evaluating 24-hour urine volumes and other risk factors; but despite this practice, 10-year recurrence rates can still be as high as 80%. Our team developed sipIT, a behavioral intervention that leverages digital tools to provide just-in-time support for fluid intake in patients with urolithiasis. The Parent R01 (DK124469) will answer the question, “Does sipIT increase 24-hour urine volume more than usual care over a 3-month period?” In this application, we propose to examine how and why this intervention works over time by answering the question, “How do the reflective and automatic behavioral processes engaged by sipIT change during and after a 3-month intervention period to influence changes in urine output?” Answers to this question may help to inform clinicians how to counsel patients to best use digital tools over time, especially during stressful life events as patients may be more susceptible to symptomatic kidney stones. This application responds to NOT-OD-23-083 (Elucidate Fundamental Processes Underlying Behavior Change, Maintenance & Adherence). The specific aims of this project are (1) to determine how the timing and amount of change in reflective and automatic motivational processes are associated with increases 24-hour urine volume, and (2) to elucidate the correlates and consequences of fluid intake habit decay following the 3-month sipIT intervention period. To achieve these aims, we propose a 24-week ambulatory monitoring study that fuses user data from a mobile app for manually tracking fluid intake with weekly self-reports during a 12-week intervention period and monthly reports during a 12-week post-intervention period. Patients with a history of kidney stones will receive the sipIT intervention for 12 weeks. We will evaluate 24-hour urine output at baseline, 12 weeks (end of intervention), and 24 weeks (maintenance). Urine output was selected as the indicator of fluid intake based on clinical guidelines for preventing recurrence of kidney stones. Findings from this project will inform decisions about how long patients should use sipIT to develop long-term habits that will maintain non-thirst driven fluid intake. Results will also illuminate the robustness of formed habits to decay following the withdrawal of (negative) reinforcement for meeting hourly fluid intake goals. These insights into the reflective and automatic mechanisms of action of sipIT will lead to a more efficient intervention that meets patients’ needs for effective long-term behavior change. Insights into how and why the sipIT intervention works will advance NIDDK goals of preventing noncancerous urologic diseases and OBSSR goals of improving synergy between basic and applied behavioral and social science research.