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Clinical Evaluation of PROMIS in CKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 13, 2019
First Posted Date February 15, 2019
Last Update Posted Date November 27, 2020
Actual Study Start Date June 22, 2017
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Evaluation of PROMIS in CKD
Official Title Clinical Evaluation of PROMIS Pediatric Person Reported Outcome Measures in Children With Chronic Kidney Disease
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Chronic Kidney Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 13, 2019)
213
Original Actual Enrollment Same as current
Actual Study Completion Date August 30, 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03842293
Other Study ID Numbers 17-013723
1U19AR069525 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Children's Hospital of Philadelphia
Original Responsible Party Same as current
Current Study Sponsor Children's Hospital of Philadelphia
Original Study Sponsor Same as current
Collaborators National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Susan Furth, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date November 2020