Health-related Quality of Life in Rare Kidney Stone

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT02124395

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

320

Enrollment

Locations

107

Duration (Months)

106.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperoxaluria Cystinuria Adenine Phosphoribosyl Transferase Deficiency Dent Disease	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

320 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Assessment of HRQoL in patients with rare kidney stones [Once a year for up to 5 years after signed consent]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic	Rochester	Minnesota	United States	55905
2	New York University School of Medicine - Cystinuria Registry	New York	New York	United States	1001+
3	APRT Registry - Landspitali Universtiy Hospital	Reykjavik		Iceland