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Clinical Evaluation of PROMIS in CKD

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ClinicalTrials.gov Identifier: NCT03842293
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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 longitudinal assessments of how measures change in association with clinical changes.

Condition or disease
Chronic Kidney Diseases

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-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.

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Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of PROMIS Pediatric Person Reported Outcome Measures in Children With Chronic Kidney Disease
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases




Primary Outcome Measures :
  1. Longitudinal change in sleep disturbance [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  2. Longitudinal change in sleep-related impairment [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  3. Longitudinal change in fatigue [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  4. Longitudinal change in life satisfaction [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  5. Longitudinal change in meaning and purpose [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  6. Longitudinal change in psychological stress experiences [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  7. Longitudinal change in global health [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  8. Longitudinal change in depressive symptoms [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  9. Longitudinal change in anxiety [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  10. Longitudinal change in positive affect [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.

  11. Longitudinal change in family relationships [ Time Frame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842293


Locations
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United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35205
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan, Mott Hospital
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Levine Children's
Charlotte, North Carolina, United States, 28203
United States, Ohio
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States, 45229
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Nationwide Children's Hopsital
Columbus, Ohio, United States, 43205
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Canada, Manitoba
Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, Canada, MB R3E 3P4
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Susan Furth, MD Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03842293    
Other Study ID Numbers: 17-013723
1U19AR069525 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency