Health-related Quality of Life in Rare Kidney Stone

Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Study Overview

• Status: Completed
• Conditions: Cystinuria; Primary Hyperoxaluria; Dent Disease; Adenine Phosphoribosyl Transferase Deficiency
• Intervention / Treatment: Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire

Detailed Description

The purpose of this study is to learn about Health-related Quality Of Life (HRQoL) in patients enrolled in the Rare Kidney Stone Consortium (RKSC) registries. Quality of life studies look at different aspects of both physical and mental components of people's lives. HRQoL data for people affected by kidney stones are not currently available for people followed over time.

• Study Type: Observational
• Enrollment (Actual): 365

Contacts and Locations

Study Locations

• Iceland
  • Reykjavik, Iceland
    • APRT Registry - Landspitali Universtiy Hospital
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic
  • New York
    • New York, New York, United States, 1001+
      • New York University School of Medicine - Cystinuria Registry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sample will be selected from the Rare Kidney Stone Consortium registries

Description

Inclusion Criteria:

• Qualify to participate in one of the Rare Kidney Stone Registries.
• Be at least 5 years old (for SF-10)
• Are able to communicate using the English language
• Consent to participate in the study (or "assent" if under 18 years old)
• Have internet access with an email account or a valid home address

Exclusion Criteria:

None, if inclusion criteria are met

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Hyperoxaluria; All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)	Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
Cystinuria; All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)	Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
Dent Disease; All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)	Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire
APRT deficiency; All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)	Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of HRQoL in patients with rare kidney stones	Assessment of HRQoL in patients with rare kidney stones. Comparison of HRQoL results between rare kidney stone formers, general population and other populations with relevant chronic diseases	Once a year for up to 5 years after signed consent

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

General Publications

• Modersitzki F, Pizzi L, Grasso M, Goldfarb DS. Health-related quality of life (HRQoL) in cystine compared with non-cystine stone formers. Urolithiasis. 2014 Feb;42(1):53-60. doi: 10.1007/s00240-013-0621-4. Epub 2013 Nov 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2013
• Primary Completion (ACTUAL): July 1, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (ESTIMATE): April 28, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Pathological Conditions, Anatomical; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Renal Tubular Transport, Inborn Errors; Renal Aminoacidurias; Urolithiasis; Urinary Calculi; Calculi; Hyperoxaluria; Cystinuria; Kidney Calculi; Nephrolithiasis; Hyperoxaluria, Primary; Dent Disease
• Other Study ID Numbers: 13-00968; 1U54DK083908-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No