Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
213 participants
OBSERVATIONAL
2017-06-22
2020-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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
8 Years
21 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Susan Furth, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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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
Countries
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Other Identifiers
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17-013723
Identifier Type: -
Identifier Source: org_study_id