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Hidrate Me Smart Water Bottle Use in Patient With Nephrolithiasis (HidrateMe)

Primary Purpose

Nephrolithiasis, Low Urine Volume

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HidrateSpark Water Bottle
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Mayo Clinic Scottsdale
  • University of Chicago
  • Indiana University
  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

HidrateSpark Water Bottle

No Smart water bottle

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 12, 2016
Last Updated
July 13, 2021
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02938884
Brief Title
Hidrate Me Smart Water Bottle Use in Patient With Nephrolithiasis
Acronym
HidrateMe
Official Title
Investigation of Non-Invasive Hydration Monitoring With Smart Water Bottle to Increase Fluid Intake in Patients With Nephrolithiasis and Low Urine Volume
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis, Low Urine Volume

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HidrateSpark Water Bottle
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Smart water bottle
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HidrateSpark Water Bottle
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in hydration adherence at 12 weeks, as determined by measurable increase in urine volume
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Borofsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://oncore.umn.edu/login/

Learn more about this trial

Hidrate Me Smart Water Bottle Use in Patient With Nephrolithiasis

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