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NephrolithiasisHidrateMeNCT02938884

Hidrate Me Smart Water Bottle Use in Patient With Nephrolithiasis

A study testing HidrateSpark Water Bottle in people with Nephrolithiasis and Low Urine Volume, run by University of Minnesota at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Nephrolithiasis, Low Urine Volume
What is being tested?
HidrateSpark Water Bottle
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
4 sitesUnited States
Study dates
5 Dec 2016to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 or older
  • History of known kidney stone event (radiographic, passed, or treated)
  • Documented history of low urinary volume on at least one 24 hour urine analysis (<1.5L) within past 6 months of potential enrollment
  • No planned changes to medication based on most recent 24 hour urine analysis

Who cannot join

  • Cognitive impairment
  • Lack of smartphone
  • Coexisting medical condition that precludes high fluid intake such as chronic kidney disease, congestive heart failure, SIADH.
  • Significant voiding dysfunction (i.e. BPH, LUTS, interstitial cystitis, neurogenic bladder, incontinence)

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Indiana University

    Bloomington, Indiana, 47405

  • University of Chicago

    Chicago, Illinois, 60637

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Investigation of Non-Invasive Hydration Monitoring With Smart Water Bottle to Increase Fluid Intake in Patients With Nephrolithiasis and Low Urine Volume

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.

Read the 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.

Being tested
HidrateSpark Water Bottle
Medical subject headings
Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HidrateSpark Water BottleDevice

    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

Study groups in NCT02938884
Study groupRoleWhat they receive
HidrateSpark Water BottleActive comparatorPatients meeting the eligibility criteria who are interested in participating in the study and randomized to receive the "HidrateSpark" water bottle be given one at no cost. They will download the associated free software application to their smartphone and be given education in the outpatient setting regarding how to use the system. All subjects in both cohorts will be provided the same questionnaire on two occasions, at the beginning and end of the trial, to determine their attitudes about fluids and potentially identify barriers to maintaining adequate hydration status (Appendix A). Additionally, standard information from the medical record including demographics, occupation, medical history and medications will be recorded.
Receives: Device: HidrateSpark Water Bottle
No Smart water bottleNo interventionAll subjects in both cohorts will be provided the same questionnaire on two occasions, at the beginning and end of the trial, to determine their attitudes about fluids and potentially identify barriers to maintaining adequate hydration status (Appendix A). Additionally, standard information from the medical record including demographics, occupation, medical history and medications will be recorded.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in hydration adherence at 12 weeks, as determined by measurable increase in urine volume

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2016 (estimated)
  2. Study start5 Dec 2016
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02938884
Sponsor's protocol ID
URO-2016-25230
Acronym
HidrateMe
Status last verified
Jul 2021
First submitted
12 Oct 2016
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing HidrateSpark Water Bottle in people with Nephrolithiasis and Low Urine Volume, run by University of Minnesota at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in hydration adherence at 12 weeks, as determined by measurable increase in urine volume (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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