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Completed

NCT Number: NCT03842293

Clinical Evaluation of PROMIS in CKD

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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