Journal
AMERICAN JOURNAL OF KIDNEY DISEASES
Volume 77, Issue 6, Pages 898-+Publisher
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.ajkd.2020.09.016
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Funding
- NIDDK [DK110986]
- Children's Hospital of Philadelphia [DK110961]
- University of Washington [DK110954]
- University of Texas Southwestern Medical Center [DK110995]
- Drs Scales and Al-Khalidi
- Duke University [DK110988]
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The PUSH Study is a randomized trial aimed at increasing and maintaining high fluid intake through a behavioral intervention program for adults and adolescents with a history of stones and low urine volume, in order to reduce stone recurrence and improve urinary symptoms.
Rationale & Objective: Although maintaining high fluid intake is an effective low-risk intervention for the secondary prevention of urinary stone disease, many patients with stones do not increase their fluid intake. Study Design: We describe the rationale and design of the Prevention of Urinary Stones With Hydration (PUSH) Study, a randomized trial of a multicomponent behavioral intervention program to increase and maintain high fluid intake. Participants are randomly assigned (1:1 ratio) to the intervention or control arm. The target sample size is 1,642 participants. Setting & Participants: Adults and adolescents 12 years and older with a symptomatic stone history and low urine volume are eligible. Exclusion criteria include infectious or monogenic causes of urinary stone disease and comorbid conditions precluding increased fluid intake. Interventions: All participants receive usual care and a smart water bottle with smartphone application. Participants in the intervention arm receive a fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions. Control arm participants receive guideline-based fluid instructions. Outcomes: The primary end point is recurrence of a symptomatic stone during 24 months of follow-up. Secondary end points include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms. Limitations: Periodic 24-hour urine volumes may not fully reflect daily behavior. Conclusions: With its highly novel features, the PUSH Study will address an important health care problem.
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