Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02938884 |
| Other study ID # |
URO-2016-25230 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 5, 2016 |
| Est. completion date |
January 31, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
University of Minnesota |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
