Fluid Intake Application to Reduce Kidney Stone Risks

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01928108
First received: August 20, 2013
Last updated: March 5, 2014
Last verified: March 2014
  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 2015
Estimated Primary Completion Date: August 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Marisa J DeBurkarte, BA 919-966-7108 made@med.unc.edu

Locations
United States, North Carolina
North Carolina Memorial Hospital Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Marisa J DeBurkarte, BA    919-966-7108    made@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Davis Viprakasit, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

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: March 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014