TY - JOUR
T1 - Prevention of Urinary Stones With Hydration (PUSH)
T2 - Design and Rationale of a Clinical Trial
AU - Urinary Stone Disease Research Network
AU - Scales, Charles D.
AU - Desai, Alana C.
AU - Harper, Jonathan D.
AU - Lai, H. Henry
AU - Maalouf, Naim M.
AU - Reese, Peter P.
AU - Tasian, Gregory E.
AU - Al-Khalidi, Hussein R.
AU - Kirkali, Ziya
AU - Wessells, Hunter
AU - Amaral, Sandra
AU - Audrain-McGovern, Janet
AU - Henderson, Brittney
AU - Koepsell, Kristen
AU - Mussell, Adam
AU - Antonelli, Jodi A.
AU - Baker, Linda A.
AU - Obiaro, Joyce
AU - Rangel, Cynthia
AU - Hill, Martinez
AU - Worsham, Madeline
AU - Cormack, Fionnuala
AU - Sorensen, Mathew
AU - Yonekawa, Karyn
AU - Covert, Holly
AU - Baxter, Tristan
AU - Ayala, Elsa
AU - Mellnick, Vincent
AU - Coplen, Douglas
AU - Taylor, Juanita
AU - Klim, Aleksandra
AU - Ksiazek, Deborah
AU - Sivalingam, Sri
AU - Dell, Katherine
AU - Calle, Juan
AU - Gotwald, Paige
AU - Markovic, Marina
AU - Lieske, John
AU - Rule, Andrew
AU - Erickson, Stephen
AU - Potrezke, Aaron
AU - Ferrero, Andrea
AU - Sas, David
AU - Waits, Angela
AU - Lenort, Courtney
AU - Weinfurt, Kevin
AU - Bosworth, Hayden
AU - Yang, Honqiu
AU - Johnson, Laura
AU - Venetta, Angela
N1 - Publisher Copyright:
© 2020 National Kidney Foundation, Inc.
PY - 2021/6
Y1 - 2021/6
N2 - 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. Funding: National Institute of Diabetes and Digestive and Kidney Diseases. Trial Registration: Registered at ClinicalTrials.gov with study number NCT03244189.
AB - 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. Funding: National Institute of Diabetes and Digestive and Kidney Diseases. Trial Registration: Registered at ClinicalTrials.gov with study number NCT03244189.
KW - RCT design
KW - Urinary stone disease (USD)
KW - behavioral intervention
KW - financial incentive
KW - fluid prescription
KW - health coaching
KW - increased fluid intake
KW - kidney disease prevention
KW - kidney stone
KW - lifestyle change
KW - lower urinary tract symptoms
KW - modifiable risk factor
KW - randomized clinical trial (RCT)
KW - stone recurrence
KW - urine volume
UR - http://www.scopus.com/inward/record.url?scp=85102293141&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85102293141&partnerID=8YFLogxK
U2 - 10.1053/j.ajkd.2020.09.016
DO - 10.1053/j.ajkd.2020.09.016
M3 - Article
C2 - 33212205
AN - SCOPUS:85102293141
SN - 0272-6386
VL - 77
SP - 898-906.e1
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
IS - 6
ER -