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Completed

NCT Number: NCT02188108

Validation of the Wisconsin Stone-QOL

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?"

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Key information

Conditions

Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stones Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh

Madison, Wisconsin, 53705-2281, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wisconsin Stone-QOL survey

Other

Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.

Primary outcomes

  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 outcomes

  1. Patients' self-reported quality of life

    Time frame: 3 months

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2023
First posted
Jul 11, 2014
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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