American journal of kidney diseases : the official journal of the National Kidney Foundation · 2020
Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.
Протокол клинического исследованияСтатьяПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Scales Charles D, Desai Alana C, Harper Jonathan D, Lai H Henry, Maalouf Naim M, Reese Peter P, Tasian Gregory E, Al-Khalidi Hussein R, Kirkali Ziya, Wessells Hunter, Urinary Stone Disease Research Network
Аннотация
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.
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.