Validation of the Wisconsin Stone-QOL

NCT02188108 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3299

Last updated 2023-07-03

No results posted yet for this study

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?"

Conditions

  • Urolithiasis
  • Nephrolithiasis
  • Kidney Stones

Interventions

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.

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER
  • University of California, San Diego

    collaborator OTHER
  • University of North Carolina

    collaborator OTHER
  • Dartmouth College

    collaborator OTHER
  • The Cleveland Clinic

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • University of Texas

    collaborator OTHER
  • University of California, Davis

    collaborator OTHER
  • University of California, Irvine

    collaborator OTHER
  • University of California, San Francisco

    collaborator OTHER
  • University of Washington

    collaborator OTHER
  • Penn State University

    collaborator OTHER
  • McGill University

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • Université de Montréal

    collaborator OTHER
  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Kristina L Penniston, PhD · University of Wisconsin Department of Urology, School of Medicine & Public Health

  • Stephen Y Nakada, MD · University of Wisconsin Department of Urology, School of Medicine & Public Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2022-05-31
Completion
2023-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02188108 on ClinicalTrials.gov