Hidrate Me Smart Water Bottle Use in Patient With Nephrolithiasis
Condition: Nephrolithiasis; Low Urine Volume
MeSH terms: Nephrolithiasis; Kidney Calculi
Study type: Interventional

Summary: 
      The primary objective of this study would be to determine whether utilization of this
      technology improves adherence to recommended increases in hydration for stone forming
      patients with low urine volume relative to standard techniques such as education and reading
      materials. We hypothesize that the addition and utilization of the smart water bottle to
      standard recommendations will lead to measurable increases 24 hour urine output for affected
      patients.
    

Detailed description: 
      Nephrolithiasis is one of the most common and costly diseases in medicine affecting nearly
      10% of the population. It is also the most costly urologic disease with an estimated ten
      billion dollars per year in associated healthcare expenditures towards treating this
      condition. One of the biggest obstacles in controlling the growing incidence of the disease
      is better preventative care, especially considering that one third to one half of the
      patients who have a single stone event will have another stone within the next ten to fifteen
      years. Despite decades of research on preventative strategies to reduce stone recurrences
      there are only a handful of dietary and medical treatments with strong evidence supporting
      their use.

      One of the cornerstones of kidney stone prevention is ensuring adequate fluid intake. Without
      adequate hydration, urinary volume is low which in turn increases super-saturation of all
      stone forming salts and increases the likelihood of stone formation. The best evidence
      supporting adequate fluid as a prevention strategy for stones comes from Borghi et al. who
      performed a 5 year randomized control study and found a 12% recurrence rate in the cohort of
      patients encouraged to achieve a goal of 2 liters (L) of urine per day compared to a 27%
      recurrence in the group who was not encouraged to increase fluid intake. Furthermore, the
      most recent guidelines by both the American Urological Association (AUA) and American College
      of Physicians (ACP) on medical management of kidney stones advocate a goal urine volume of
      2.5 L for all stone formers.

      Despite recommendations and evidence supporting its utility as an effective prevention
      mechanism for stone formers, achieving significant increases in hydration and subsequently
      urinary volumes remains a considerable clinical challenge. To date, adherence to increased
      fluid recommendations has been understudied with little data assessing patient compliance
      specifically for fluid. However, noncompliance with metabolic treatment of nephrolithiasis is
      common with estimates that only 50% of patients follow recommendations.These rates are
      similar to rates of noncompliance with recommended care in other chronic medical conditions
      as well including diabetes, chronic kidney disease, congestive heart failure, and metabolic
      syndrome.

      Recently, mobile health technology has received much attention as a potential aide in helping
      improve compliance with medically indicated lifestyle and dietary treatments. Early studies
      using "smart technology" and mobile health applications have shown that implementation of
      such strategies can not only be beneficial in improving compliance, but also have the
      potential to lead to sustainable behavioral change. To date, there are no studies looking at
      mobile health technology as it applies to increasing fluid intake, particularly among stone
      formers.

      Recently, a novel "smart" water bottle called "HidrateSpark" (www.hidratespark.com) developed
      by researchers at the University of Minnesota has been developed for use as a noninvasive
      fluid intake monitoring system. The device uses capacitive touch sensing via a sensor
      extending from the lid to the base, which calculates volume measurements by detecting changes
      in water levels. Data from the bottle is sent wirelessly to users' smartphones through an
      application.

      This device has significant potential for use particularly among stone former that have
      demonstrated difficulty increasing their hydration as a part of preventative care. The device
      would not only allow users the ability to closely monitor their fluid intake throughout the
      day, it would also engage the patient with reminders to drink periodically throughout the day
      and stay hydrated. Additionally, fluid intake measurements stored through the associated
      application have the potential to be used as a novel metric capable of being brought to the
      provider's attention in order to better assess and guide patient hydration status and
      identify barriers to achieving hydration goals.

      The primary objective of this study would be to determine whether utilization of this
      technology improves adherence to recommended increases in hydration for stone forming
      patients with low urine volume relative to standard techniques such as education and reading
      materials. We hypothesize that the addition and utilization of the smart water bottle to
      standard recommendations will lead to measurable increases 24 hour urine output for affected
      patients.
    

Intervention name(s): HidrateSpark Water Bottle
Intervention type(s): Device
Intervention description(s): HidrateSpark water bottle is a smart water bottle that glow when its time to drink water. It is run through an app on a smart phone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment