NCT02188108

Validation of the Wisconsin Stone-QOL

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,299 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urolithiasis
• Nephrolithiasis
• Kidney Stones

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2022-05-31
• Completion: 2023-06-30
• First posted: 2014-07-11
• Last updated: 2023-07-03

Locations

1 site across 1 country: United States