An observational study in Chronic Kidney Diseases, sponsored by Children's Hospital of Philadelphia. Completed at 16 sites in 2 countries. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2020-11-27.
Sponsored by Children's Hospital of Philadelphia · Observational
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 213 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
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Participants were initially recruited through an existing study, the Chronic Kidney Disease in Children (CKiD) study. CKiD is a long-term prospective cohort study that currently follows 364 children with CKD from 54 North American centers. Recruitment was expanded to also enroll children between the ages of 8 and 21 years who had been seen at a nephrology clinic at two CKiD participating sites, Children's Hospital of Philadelphia (CHOP) and Cincinnati Children's Hospital and Medical Center (CCHMC) and had two eGFR readings (computed from serum creatinine) between 6-89 ml/min at least 3 months apart (eGFR of this level indicates CKD).
Exclusion Criteria:
Longitudinal change in sleep disturbance
Child self-report of 8 items from PROMIS sleep-related disturbance domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in sleep-related impairment
Child self-report of 4 items from PROMIS sleep-related impairment domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in fatigue
Child self-report of 8 items from PROMIS fatigue domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in life satisfaction
Child self-report of 4 items from from PROMIS life satisfaction domain. Participants rate their experience using a five point scale ranging from not at all to quite a bit. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in meaning and purpose
Child self-report of 4 items from from PROMIS meaning and purpose domain. Participants rate their experience using a five point scale ranging from not at all to quite a bit. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in psychological stress experiences
Child self-report of 4 items from from PROMIS psychological stress experiences domain. Participants rate their experience using a five point scale ranging from not at all to quite a bit. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in global health
Parent proxy report of 7 items from from PROMIS global health domain. Parents rate their child's experience using a five point scale ranging from poor to excellent. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in depressive symptoms
Parent proxy report of 4 items from from PROMIS emotional distress - depressive symptoms domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in anxiety
Parent proxy report of 4 items from from PROMIS emotional distress - anxiety domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in positive affect
Parent proxy report of 4 items from from PROMIS positive affect domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in family relationships
Parent proxy report of 4 items from from PROMIS family relationships domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.
Time frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia