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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

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

Clinical Evaluation of PROMIS in CKD | DecenTrialz