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

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ClinicalTrials.gov Identifier: NCT02938884
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Nephrolithiasis Low Urine Volume Device: HidrateSpark Water Bottle Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Non-Invasive Hydration Monitoring With Smart Water Bottle to Increase Fluid Intake in Patients With Nephrolithiasis and Low Urine Volume
Actual Study Start Date : December 5, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HidrateSpark Water Bottle

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.

Device: HidrateSpark Water Bottle
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

No Intervention: No Smart water bottle
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.



Primary Outcome Measures :
  1. Change from baseline in hydration adherence at 12 weeks, as determined by measurable increase in urine volume [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938884


Contacts
Contact: Michael Borofsky, MD 2484171851 mborofsk@umn.edu

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Mitchell Humphreys         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Anna Zisman, MD         
United States, Indiana
Indiana University Recruiting
Bloomington, Indiana, United States, 47405
Contact: James Lingeman         
Contact: Amy Krambeck         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: John Knoedler         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Michael Borofsky, MD University of Minnesota - Clinical and Translational Science Institute

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02938884     History of Changes
Other Study ID Numbers: 1609M94062
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical