Validation of the Wisconsin Stone-QOL

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Recruiting

CT.gov ID

NCT02188108

Collaborator

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

3,500

Enrollment

Location

Arm

101

Duration (Months)

34.6

Patients Per Site Per Month

Study Details

Study Description

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:

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?"
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?"

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis Nephrolithiasis Kidney Stones	Other: Wisconsin Stone-QOL survey	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Patients' self-reported quality of life [3 months]

Other Outcome Measures

Patients' self-reported quality of life [12 months]
Patients' self-reported quality of life [24 months]
Patients' self-reported quality of life [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh	Madison	Wisconsin	United States	53705-2281

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