Clinical Evaluation of PROMIS in CKD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of PROMIS Pediatric Person Reported Outcome Measures in Children With Chronic Kidney Disease

Conditions
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Chronic Kidney Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. |