Clinical Evaluation of PROMIS in CKD

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Chronic Kidney Diseases

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03842293

17-013723

1U19AR069525 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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-proxy editions. Cross-sectional evaluations of the validity of the instruments have established that they are ready for integration into clinical research and practice. The next step in their ongoing evaluation is to assess their prospective clinical validity in a variety of health conditions. This study addresses the clinical evaluation of the measures in children with chronic kidney disease (CKD).

Through baseline surveys and six follow-up surveys over a two-year period, Investigators are collecting self-report (child) and parent-proxy report of 11 pediatric PROMIS measures. Each of these PROMIS measures is described in the Main Outcome Measures section. Investigators are also collecting assessments of disease activity from clinical data. The selection of self-report and parent proxy patient-reported outcome (PRO) measures were determined through qualitative content validation. The analytic goal of this project is to evaluate baseline (cross-sectional) and longitudinal associations between PROMIS pediatric outcome measures and changes in the clinical status of patients with CKD. Our primary hypothesis is that as kidney function declines, self-reported health will worsen.

Enrollment: 213 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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