Status:
COMPLETED
Clinical Evaluation of PROMIS in CKD
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
8-21 years
Brief Summary
The purpose of this study is to evaluate the clinical validity of a set of PROMIS pediatric person-reported outcome measures in patients with chronic kidney disease. The evaluation includes longitudin...
Detailed Description
The National Institutes of Health (NIH)-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) network has developed over 20 pediatric instruments, both child-report and parent-pr...
Eligibility Criteria
Inclusion
- Child is 8-21 years old at time of enrollment
- Child is a Chronic Kidney Disease in Children (CKiD) patient OR a child who receives pediatric nephrology care at a CKiD site that participates in PEDSnet, a national pediatric learning health system
- Child seen by a pediatric nephrologist in the past 24 months
- Child has two eGFR readings (computed from serum creatinine) between 6-89 ml/min at least 3 months apart (eGFR of this level indicates CKD)
- Child speaks English
- Parent is the parent or legal guardian for the child
- Parent speaks English
Exclusion
- Child is currently receiving dialysis
- Child received a kidney transplant
- Child has a parent-reported cognitive limitation that would preclude them from completing a questionnaire
- Child does not speak English
- Parent does not speak English
- Parent is not the parent of legal guardian for the child
Key Trial Info
Start Date :
June 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT03842293
Start Date
June 22 2017
End Date
August 30 2020
Last Update
November 27 2020
Active Locations (16)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35205
2
UCLA
Los Angeles, California, United States, 90095
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
4
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202