NCT01928108

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3.7 years

First QC Date

August 20, 2013

Last Update Submit

March 24, 2017

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (1)

  • 24-hour urine volume

    7-10 days from baseline

Secondary Outcomes (2)

  • Actual 24-hour urine volume vs. patient perceived urine volume

    7-10 days from baseline

  • Ease and interest in monitoring fluid intake based on survey data

    7-10 days from baseline

Other Outcomes (1)

  • 24-hour urine volume for study participants vs. urine volume for retrospective cohort of previously treated kidney stone patients

    7-10 days from baseline

Study Arms (2)

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

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

Interventions

iPhone ApplicationBEHAVIORAL

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.

iPhone Application
Android ApplicationBEHAVIORAL

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.

Android Application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Memorial Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

  • 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.

    PMID: 22498635BACKGROUND

  • Preminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16.

    PMID: 1561497BACKGROUND

  • 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.

    PMID: 7396311BACKGROUND

  • 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.

    PMID: 8583588BACKGROUND

  • 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.

    PMID: 12576800BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Davis Viprakasit, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 23, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 16, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

US(1)