- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01928108
Fluid Intake Application to Reduce Kidney Stone Risks
March 24, 2017 updated by: University of North Carolina, Chapel Hill
Do Different Methods of Educating Patients Regarding Fluid Intake Reduce Kidney Stone Risks?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- North Carolina Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be Patients ≥ 18 years old, seen in urology or nephrology clinic with a diagnosis of kidney stone, and had a prior 24-hour urine result with volume less than 2 to 2.5 liters
Description
Inclusion Criteria:
- Patients ≥ 18 years old
- Seen in urology or nephrology clinic at UNC with a diagnosis of kidney stone
- Prior 24-hour urine result with volume less than 2 to 2.5 liters
Exclusion Criteria:
- Patient without cellular phone capable of utilizing Android / Apple application
- Patient already using some form of monitoring fluid intake / volume
- Inability to take fluid by mouth
- Patient with urinary diversion, chronic diarrhea, bowel diversion or other forms of excessive fluid loss
- Inability to obtain informed consent
- Non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
iPhone Application
Participants using an iPhone will download the "waterlogged" application and use this to track daily water intake for 1 week.
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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.
|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour urine volume
Time Frame: 7-10 days from baseline
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7-10 days from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Actual 24-hour urine volume vs. patient perceived urine volume
Time Frame: 7-10 days from baseline
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7-10 days from baseline
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Ease and interest in monitoring fluid intake based on survey data
Time Frame: 7-10 days from baseline
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7-10 days from baseline
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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7-10 days from baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Davis Viprakasit, MD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
- Preminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16.
- Pak CY, Sakhaee K, Crowther C, Brinkley L. Evidence justifying a high fluid intake in treatment of nephrolithiasis. Ann Intern Med. 1980 Jul;93(1):36-9. doi: 10.7326/0003-4819-93-1-36.
- Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A. Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study. J Urol. 1996 Mar;155(3):839-43.
- Parks JH, Goldfischer ER, Coe FL. Changes in urine volume accomplished by physicians treating nephrolithiasis. J Urol. 2003 Mar;169(3):863-6. doi: 10.1097/01.ju.0000044922.22478.32.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 16, 2017
Study Registration Dates
First Submitted
August 20, 2013
First Submitted That Met QC Criteria
August 22, 2013
First Posted (Estimate)
August 23, 2013
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-2453
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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