Kidney StoneNCT01928108
Fluid Intake Application to Reduce Kidney Stone Risks
An observational study of Kidney Stone, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- iPhone Application and Android Application
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 16 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Memorial Hospital
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Stone
- Being tested
- iPhone Application, Android Application
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPhone ApplicationBehavioural
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 ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iPhone Application | Participants using an iPhone will download the "waterlogged" application and use this to track daily water intake for 1 week. Receives: 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. Receives: Behavioral: Android Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urine volume
Measured: 7-10 days from baseline
Secondary outcomes (2)
Actual 24-hour urine volume vs. patient perceived urine volume
Measured: 7-10 days from baseline
Ease and interest in monitoring fluid intake based on survey data
Measured: 7-10 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startJul 2013
- Primary completion1 Mar 2017
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davis Viprakasit, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928108
- Sponsor's protocol ID
- 13-2453
- Status last verified
- Mar 2017
- First submitted
- 20 Aug 2013
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22498635Preminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16.
PubMed 1561497Pak 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.
PubMed 7396311Borghi 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.
PubMed 8583588Parks 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.
PubMed 12576800
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Different Methods of Educating Patients Regarding Fluid Intake Reduce Kidney Stone Risks?
- ClinicalTrials.gov ID
- NCT01928108
- Acronym / sponsor ID
- 13-2453
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPhone Application | – | Behavioral: iPhone ApplicationParticipants using an iPhone will download the "waterlogged" application and use this to track daily water intake for 1 week. |
| Android Application | – | Behavioral: Android ApplicationParticipants using an Android cell phone will download the "water your body" application and use this to track daily water intake for 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPhone ApplicationThe 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. | Behavioural | iPhone Application |
| Android ApplicationThe 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. | Behavioural | Android Application |
Primary outcome
24-hour urine volume
Time frame: 7-10 days from baseline
2 secondary outcomes
Actual 24-hour urine volume vs. patient perceived urine volume
Time frame: 7-10 days from baseline
Ease and interest in monitoring fluid intake based on survey data
Time frame: 7-10 days from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Background: PubMed 22498635Scales 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.
- Background: PubMed 1561497Preminger GM. Renal calculi: pathogenesis, diagnosis, and medical therapy. Semin Nephrol. 1992 Mar;12(2):200-16.
- Background: PubMed 7396311Pak 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.
- Background: PubMed 8583588Borghi 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.
- Background: PubMed 12576800Parks 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davis Viprakasit, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urine volume (time frame: 7-10 days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928108, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.