Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.
Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.
复制标题
水化预防尿路结石(PUSH)：一项临床试验的设计和基本原理。
DOI：
10.1053/j.ajkd.2020.09.016
复制
发表时间：
2021-06
期刊：
影响因子：
--
通讯作者：
Urinary Stone Disease Research Network
中科院分区：
文献类型：
--
作者：
Scales CD Jr;Desai AC;Harper JD;Lai HH;Maalouf NM;Reese PP;Tasian GE;Al-Khalidi HR;Kirkali Z;Wessells H;Urinary Stone Disease Research Network
虽然保持高液体摄入量是一种有效的，低风险的干预泌尿系结石病（USD）的二级预防，许多结石患者不增加他们的液体摄入量。我们描述了水化预防尿结石（PUSH）研究的原理和设计，这是一项多组分行为干预计划的随机试验，旨在增加和维持高液体摄入量。参与者被随机（1：1的比例）分配到干预组或对照组，目标样本量为1642名参与者。有症状性结石病史和尿量低的成人和≥12岁的青少年合格。排除标准包括感染性或单基因原因的USD和共病条件排除增加液体摄入量。所有参与者都将获得常规护理、智能水瓶和智能手机应用程序。干预组的参与者接受液体摄入处方和行为干预的适应性计划，包括经济激励，结构化问题解决和其他自动遵守干预。控制臂参与者接收基于指南的流体指令。主要终点是随访24个月内症状性结石复发。次要终点包括放射学结石负荷、24小时尿量和泌尿系统症状的变化。定期24小时尿量可能不能完全反映日常行为。凭借其高度新颖的功能，PUSH研究将解决一个重要的医疗保健问题。增加低尿量尿结石患者的液体摄入量是预防结石复发的必要条件，但在临床实践中难以实现。水合预防尿结石（PUSH）研究是一项随机临床试验，使用“智能”水瓶来跟踪液体摄入量，并检查行为干预措施的组合（包括“液体处方”、经济激励和指导）是否可以提高对较高液体摄入量的坚持并减少结石复发。我们描述了这项大型多中心随机试验的基本原理和设计，该试验目前招募了1,642名结石形成者，其结局包括症状性结石复发、无症状（放射学）结石疾病进展和与疾病相关的尿液参数。
Although maintaining high fluid intake is an effective, low-risk intervention for the secondary prevention of urinary stone disease (USD), many stone patients do not increase their fluid intake. We describe the rationale and design of the Prevention of Urinary Stones with Hydration (PUSH) study, a randomized trial of a multi-component behavioral intervention program to increase and maintain high fluid intake. Participants are randomized (1:1 ratio) to intervention or control arm. The target sample size is 1642 participants. Adults and adolescents ≥12 years of age with a symptomatic stone history and low urine volume are eligible. Exclusion criteria include infectious or monogenic causes of USD and comorbid conditions precluding increased fluid intake. All participants receive usual care and a smart water bottle and 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. The primary endpoint is recurrence of a symptomatic stone over 24-months of follow-up. Secondary endpoints include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms. Periodic 24-hour urine volumes may not fully reflect daily behavior. With its highly novel features, the PUSH study will address an important healthcare problem. Increasing fluid intake in urinary stone formers with low urine volume is essential to prevent stone recurrence, but difficult to achieve in clinical practice. The Prevention of Urinary Stones with Hydration (PUSH) study is a randomized clinical trial that uses a “smart” water bottle to track fluid intake and examines whether a combination of behavioral interventions (including a “fluid prescription”, financial incentives, and coaching) improves adherence to higher fluid intake and reduces stone recurrence. We describe the rationale and design of this large multicenter randomized trial currently enrolling 1,642 stone formers, with outcomes including symptomatic stone recurrence, asymptomatic (radiographic) stone disease progression, and urinary parameters associated with disease.
登录
查看更多内容
影响因子：
120.7
作者：
Volpp, Kevin G.;John, Leslie K.;Troxel, Andrea B.;Norton, Laurie;Fassbender, Jennifer;Loewenstein, George
通讯作者：
Loewenstein, George
影响因子：
2.8
作者：
Volpp KG;Loewenstein G;Troxel AB;Doshi J;Price M;Laskin M;Kimmel SE
通讯作者：
Kimmel SE
影响因子：
4.8
作者：
Kimmel SE;Troxel AB;Loewenstein G;Brensinger CM;Jaskowiak J;Doshi JA;Laskin M;Volpp K
通讯作者：
Volpp K
影响因子：
6
作者：
Higgins, Stephen T.;Bernstein, Ira M.;Solomon, Laura J.
通讯作者：
Solomon, Laura J.
影响因子：
2.3
作者：
Vandrey, Ryan;Bigelow, George E.;Stitzer, Maxine L.
通讯作者：
Stitzer, Maxine L.