Clinical Evaluation of PROMIS in CKD

• ClinicalTrials.gov Identifier: NCT03842293
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Last Update Posted: November 27, 2020
• Sponsor: Children's Hospital of Philadelphia
• 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
• 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

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

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