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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

Tracking Information
First Submitted Date  ICMJE July 7, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date September 14, 2020
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
Patients' self-reported health-related quality of life [ Time Frame: Enrollment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
Patients' self-reported quality of life [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2014)
  • Patients' self-reported quality of life [ Time Frame: 12 months ]
  • Patients' self-reported quality of life [ Time Frame: 24 months ]
  • Patients' self-reported quality of life [ Time Frame: 36 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Validation of the Wisconsin Stone-QOL
Official Title  ICMJE Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers
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?"
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Urolithiasis
  • Nephrolithiasis
  • Kidney Stones
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Wisconsin Stone-QOL survey
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2014)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristina L Penniston, PhD 608-265-9797 penn@urology.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188108
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account University of Wisconsin, Madison
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP