Clinical Evaluation of PROMIS in CKD

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842293
• Other study ID #: 17-013723
• Secondary ID: 1U19AR069525
• Status: Completed
• Start date: June 22, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: November 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Canada	Children's Hospital Research Institute of Manitoba	Winnipeg	Manitoba
United States	University of Michigan, Mott Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Johns Hopkins Children's Center	Baltimore	Maryland
United States	Children's Hospital of Alabama	Birmingham	Alabama
United States	Levine Children's	Charlotte	North Carolina
United States	Cincinnati Children's Hospital and Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Nationwide Children's Hopsital	Columbus	Ohio
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	UCLA	Los Angeles	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal change in sleep disturbance	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in sleep-related impairment	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in fatigue	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in life satisfaction	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in meaning and purpose	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in psychological stress experiences	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in global health	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in depressive symptoms	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in anxiety	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in positive affect	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Primary	Longitudinal change in family relationships	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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.