Validation of the Wisconsin Stone-QOL

Not Applicable

Completed

• Conditions: Nephrolithiasis; Kidney Stones; Urolithiasis
• Interventions: Other: Wisconsin Stone-QOL survey

• Registration Number: NCT02188108
• Lead Sponsor: University of Wisconsin, Madison

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Primary Completion: 2022-05-31
• Status Verified: 2023-06
• Study Completion: 2023-06-30
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3299

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Survey	Wisconsin Stone-QOL 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.

Primary Outcome Measures

Name	Time	Method
Patients' self-reported health-related quality of life (HRQOL)	Enrollment	Change in HRQOL from baseline to follow-up time points will be assessed

Secondary Outcome Measures

Name	Time	Method
Patients' self-reported quality of life	3 months

Trial Locations

Locations (1)

University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh; 🇺🇸 Madison, Wisconsin, United States