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Fluid Intake Application to Reduce Kidney Stone Risks

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01928108
First received: August 20, 2013
Last updated: October 8, 2015
Last verified: September 2015
  Purpose
The purpose of this investigation is to prospectively evaluate the benefit of different methods of educating patients regarding their fluid intake through a readily available daily cellular phone application to improve overall urine output and reduce risk factors for stone recurrence.

Condition Intervention
Kidney Stone
Behavioral: iPhone Application
Behavioral: Android Application
Device: iPhone cellular
Device: Android cellular

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Do Different Methods of Educating Patients Regarding Fluid Intake Reduce Kidney Stone Risks?

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 24-hour urine volume [ Time Frame: 7-10 days from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Actual 24-hour urine volume vs. patient perceived urine volume [ Time Frame: 7-10 days from baseline ] [ Designated as safety issue: No ]
  • Ease and interest in monitoring fluid intake based on survey data [ Time Frame: 7-10 days from baseline ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 24-hour urine volume for study participants vs. urine volume for retrospective cohort of previously treated kidney stone patients [ Time Frame: 7-10 days from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iPhone Application
Participants using an iPhone will download the "waterlogged" application and use this to track daily water intake for 1 week.
Behavioral: iPhone Application
The iPhone application "waterlogged" will be used by participants using and iPhone cellular device. This application will be used to track daily fluid intake for 1 week.
Device: iPhone cellular
Experimental: Android Application
Participants using an Android cell phone will download the "water your body" application and use this to track daily water intake for 1 week.
Behavioral: Android Application
The Android application "water my body" will be used by participants using an Android cellular device. This application will be used to track daily fluid intake for 1 week.
Device: Android cellular

Detailed Description:
The prevalence of kidney stone disease in the United States is increasing. Recurrence of kidney stone disease has been reported as high as 50% at five years. Urine supersaturation is a predominant factor in the formation of crystallization and stone disease and is dependent on fluid volume. High fluid consumption that dilutes the urine has been shown both in vitro and in clinical studies to reduce the tendency for stone crystallization as well as effectively decrease stone recurrence. As a result, water intake greater than two liters per day is a common initial therapy for prevention of stone disease. However, studies have shown that despite physician counseling most patients are only able to modestly increase their urine volume through fluid intake. This finding may be due to a discrepancy in patient perception of their actual fluid intake and resulting urine volume. The purpose of this investigation is to prospectively evaluate the benefit of different methods of educating patient regarding their fluid intake through a readily available daily cellular phone application to improve overall urine output and reduce risk factors for stone recurrence.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 18 years old
  2. Seen in urology or nephrology clinic at UNC with a diagnosis of kidney stone
  3. Prior 24-hour urine result with volume less than 2 to 2.5 liters

Exclusion Criteria:

  1. Patient without cellular phone capable of utilizing Android / Apple application
  2. Patient already using some form of monitoring fluid intake / volume
  3. Inability to take fluid by mouth
  4. Patient with urinary diversion, chronic diarrhea, bowel diversion or other forms of excessive fluid loss
  5. Inability to obtain informed consent
  6. Non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928108

Locations
United States, North Carolina
North Carolina Memorial Hospital
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Davis Viprakasit, MD University of North Carolina, Chapel Hill
  More Information

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01928108     History of Changes
Other Study ID Numbers: 13-2453 
Study First Received: August 20, 2013
Last Updated: October 8, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Methyltestosterone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016