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.
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
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.
- Conditions
- Nephrolithiasis, Low Urine Volume
- 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 group | Role | What they receive |
|---|---|---|
| HidrateSpark Water Bottle | Active comparator | Patients 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 bottle | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted19 Oct 2016 (estimated)
- Study start5 Dec 2016
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Borofsky, MD, Principal investigator, University of Minnesota
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Non-Invasive Hydration Monitoring With Smart Water Bottle to Increase Fluid Intake in Patients With Nephrolithiasis and Low Urine Volume
- ClinicalTrials.gov ID
- NCT02938884
- Acronym / sponsor ID
- HidrateMe / URO-2016-25230
- Conditions
- Nephrolithiasis, Low Urine Volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HidrateSpark Water Bottle | Active comparator | Device: HidrateSpark Water BottlePatients 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. |
| No Smart water bottle | No intervention | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HidrateSpark Water BottleHidrateSpark 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 | Device | HidrateSpark Water Bottle |
Primary outcome
Change from baseline in hydration adherence at 12 weeks, as determined by measurable increase in urine volume
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Borofsky, MD principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
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.