Clinical trial NCT03842293: Clinical Evaluation of PROMIS in CKD
Official title: Clinical Evaluation of PROMIS Pediatric Person Reported Outcome Measures in Children With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-02-15
Enrollment: 213
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Longitudinal change in sleep disturbance
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in sleep-related impairment
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in fatigue
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in life satisfaction
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in meaning and purpose
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in psychological stress experiences
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in global health
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in depressive symptoms
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in anxiety
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in positive affect
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
measure: Longitudinal change in family relationships
timeFrame: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan, Mott Hospital
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Charlotte
country: United States
facility: Levine Children's
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital and Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hopsital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Winnipeg
country: Canada
facility: Children's Hospital Research Institute of Manitoba
state: Manitoba
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Susan Furth, MD
role: PRINCIPAL_INVESTIGATOR
References: