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Validation of the Wisconsin Stone-QOL

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ClinicalTrials.gov Identifier: NCT02188108
Recruitment Status : Recruiting
First Posted : July 11, 2014
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
University of Florida
University of California, San Diego
University of North Carolina
Dartmouth College
The Cleveland Clinic
University of British Columbia
University of Texas
University of California, Davis
University of California, Irvine
University of California, San Francisco
University of Washington
Penn State University
McGill University
University of Pittsburgh
Université de Montréal
University of Kentucky
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief Summary:

The overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (HRQOL) of patients who have had kidney stones. Specific aims of this study are:

  1. Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin Stone-QOL by answering the question, "Is the Wisconsin Stone-QOL useful for assessing the HRQOL of patients who form kidney stones from a broad region of North America?"
  2. Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients related to stone interventions and other disease-specific outcomes by answering the question, "Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes within individuals?"

Condition or disease Intervention/treatment Phase
Urolithiasis Nephrolithiasis Kidney Stones Other: Wisconsin Stone-QOL survey Not Applicable

Detailed Description:

The Wisconsin Stone-QOL was developed as the only known HRQOL instrument designed specifically for patients with kidney stones. Its development has been published. Internal and other validity tests on the instrument have been conducted and reported. Further validity testing of the instrument is needed to confirm its broader utility in the context of surgical and medical management of patients with kidney stones.

Upon enrollment at each site, patients will be asked to complete a medical history form and the Wisconsin Stone-QOL. To supplement the information provided in the medical history forms, patients' medical records will be reviewed in order to collect and enter approved data into a spreadsheet. Further patient interventions include completion of the Wisconsin Stone-QOL at 3 months, 12 months, 24 months, and 36 months post-enrollment. These post-enrollment surveys will usually be mailed to patients to the addresses they provide. Alternatively, patients may be provided the surveys at a urology encounter if it falls on or near the intervention time points. At each time point, patients' medical records will also be searched to document any changes in the data entered at enrollment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers
Study Start Date : July 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arms and Interventions
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Arm Intervention/treatment
Experimental: Survey
Wisconsin Stone-QOL survey. Patients with kidney stones or a history thereof will complete a kidney stone-specific health-related survey at enrollment and post-enrollment at 3 months, 12 months, 24 months, and 36 months.
 Other: Wisconsin Stone-QOL survey
Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.


Outcome Measures
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Primary Outcome Measures :
  1. Patients' self-reported health-related quality of life (HRQOL) [ Time Frame: Enrollment ]
    Change in HRQOL from baseline to follow-up time points will be assessed


Secondary Outcome Measures :
  1. Patients' self-reported quality of life [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Patients' self-reported quality of life [ Time Frame: 12 months ]
  2. Patients' self-reported quality of life [ Time Frame: 24 months ]
  3. Patients' self-reported quality of life [ Time Frame: 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of kidney stones, either in the past or currently
  • 18 years of age or older

Exclusion Criteria:

  • Under 18 years of age
  • No previous or current diagnosis of kidney stones
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188108


Contacts
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Contact: Kristina L Penniston, PhD 608-265-9797 penn@urology.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh Recruiting
Madison, Wisconsin, United States, 53705-2281
Contact: Kristina L Penniston, PhD    608-265-9797    penn@urology.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
University of Florida
University of California, San Diego
University of North Carolina
Dartmouth College
The Cleveland Clinic
University of British Columbia
University of Texas
University of California, Davis
University of California, Irvine
University of California, San Francisco
University of Washington
Penn State University
McGill University
University of Pittsburgh
Université de Montréal
University of Kentucky
Investigators
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Principal Investigator: Kristina L Penniston, PhD University of Wisconsin Department of Urology, School of Medicine & Public Health
Principal Investigator: Stephen Y Nakada, MD University of Wisconsin Department of Urology, School of Medicine & Public Health
More Information
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Publications:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02188108    
Other Study ID Numbers: 2014-0062
UW QOL ( Other Identifier: Study Team )
A539998 ( Other Identifier: UW Madison )
SMPH\VOLUNTEER STAFF\UROLOGY ( Other Identifier: UW Madison )
Protocol Version 1/19/2018 ( Other Identifier: UW Madison )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Keywords provided by University of Wisconsin, Madison:
quality of life
QOL
urolithiasis
 nephrolithiasis
kidney stones
patient-reported outcomes
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Urolithiasis
Urinary Calculi
 Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases