Clinical Evaluation of PROMIS in CKD

Completed

Conditions studied: Chronic Kidney Diseases

In brief

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 longitudinal assessments of how measures change in association with clinical changes.

Key facts

Study ID

NCT03842293

Run by

Children's Hospital of Philadelphia

People needed

213

Starts

2017-06-22

Expected to finish

2020-08-30

Last updated by the study team

2020-11-27

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• UCLA — Los Angeles, California, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Johns Hopkins Children's Center — Baltimore, Maryland, United States
• University of Michigan, Mott Hospital — Ann Arbor, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Levine Children's — Charlotte, North Carolina, United States
• Cincinnati Children's Hospital and Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Nationwide Children's Hopsital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Children's Hospital Research Institute of Manitoba — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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