Validation of the Wisconsin Stone-QOL
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|ClinicalTrials.gov Identifier: NCT02188108|
Recruitment Status : Recruiting
First Posted : July 11, 2014
Last Update Posted : September 14, 2020
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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
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.
- 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
- Patients' self-reported quality of life [ Time Frame: 3 months ]
- Patients' self-reported quality of life [ Time Frame: 12 months ]
- Patients' self-reported quality of life [ Time Frame: 24 months ]
- Patients' self-reported quality of life [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188108
|Contact: Kristina L Penniston, PhDemail@example.com|
|United States, Wisconsin|
|University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh||Recruiting|
|Madison, Wisconsin, United States, 53705-2281|
|Contact: Kristina L Penniston, PhD 608-265-9797 firstname.lastname@example.org|
|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|