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Health-related Quality of Life in Rare Kidney Stone

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by New York University School of Medicine
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02124395
First received: April 23, 2014
Last updated: December 13, 2016
Last verified: December 2016
  Purpose
Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Condition Intervention
Primary Hyperoxaluria Cystinuria Adenine Phosphoribosyl Transferase Deficiency Dent Disease Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Assessment of HRQoL in patients with rare kidney stones [ Time Frame: 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


Estimated Enrollment: 320
Study Start Date: August 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sample will be selected from the Rare Kidney Stone Consortium registries
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02124395

Contacts
Contact: Frank Modersitzki, MPH 212-686-7500 ext 6379 Frank.Modersitzki@nyumc.org

Locations
United States, Minnesota
Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Barb M Seide, Study Coord    800-270-4637    hyperoxaluriacenter@mayo.edu   
Principal Investigator: Dawn S Milliner, MD         
United States, New York
New York University School of Medicine - Cystinuria Registry Recruiting
New York, New York, United States, 1001+
Contact: Frank Modersitzki, MPH    212-686-7500 ext 6379    Frank.Modersitzki@nyumc.org   
Principal Investigator: David S Goldfarb, MD         
Iceland
APRT Registry - Landspitali Universtiy Hospital Not yet recruiting
Reykjavik, Iceland
Contact: Vidar Edvardsson, MD    354-824-5227    vidare@landspitali.is   
Principal Investigator: Vidar Edvardsson, MD         
Sponsors and Collaborators
New York University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: David Goldfarb, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02124395     History of Changes
Other Study ID Numbers: 6408
1U54DK083908-01 ( US NIH Grant/Contract Award Number )
Study First Received: April 23, 2014
Last Updated: December 13, 2016

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Hyperoxaluria, Primary
Dent Disease
Cystinuria
Metabolism, Inborn Errors
Urolithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Hyperoxaluria
Carbohydrate Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Genetic Diseases, X-Linked
Renal Aminoacidurias

ClinicalTrials.gov processed this record on June 23, 2017