Validation of the Wisconsin Stone-QOL

June 30, 2023 updated by: University of Wisconsin, Madison

Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers

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?"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3299

Phase

  • Not Applicable

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

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2281
        • University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh

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

Description

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

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients' self-reported quality of life
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Patients' self-reported quality of life
Time Frame: 12 months
12 months
Patients' self-reported quality of life
Time Frame: 24 months
24 months
Patients' self-reported quality of life
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

University of British Columbia
University of California, San Diego
McGill University
University of Pittsburgh
The Cleveland Clinic
University of Florida
University of California, Davis
University of Washington
University of California, San Francisco
University of California, Irvine
Penn State University
University of Texas
Dartmouth College
Université de Montréal
University of North Carolina

Investigators

  • 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

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

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, 2014

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimated)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

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.

Clinical Trials on Nephrolithiasis

Clinical Trials on Wisconsin Stone-QOL survey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe