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

Study Description

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.

Condition or disease
Chronic Kidney Diseases

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 Design

• Study Type: Observational
• Actual Enrollment: 213 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Evaluation of PROMIS Pediatric Person Reported Outcome Measures in Children With Chronic Kidney Disease
• Actual Study Start Date: June 22, 2017
• Actual Primary Completion Date: August 30, 2020
• Actual Study Completion Date: August 30, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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).

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

Contacts and Locations

Locations

United States, Alabama

Children's Hospital of Alabama

Birmingham, Alabama, United States, 35205

United States, California

UCLA

Los Angeles, California, United States, 90095

United States, Georgia

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

United States, Indiana

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

United States, Maryland

Johns Hopkins Children's Center

Baltimore, Maryland, United States, 21287

United States, Michigan

University of Michigan, Mott Hospital

Ann Arbor, Michigan, United States, 48109

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

St. Louis Children's Hospital

Saint Louis, Missouri, United States, 63110

United States, North Carolina

Levine Children's

Charlotte, North Carolina, United States, 28203

United States, Ohio

Cincinnati Children's Hospital and Medical Center

Cincinnati, Ohio, United States, 45229

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Nationwide Children's Hopsital

Columbus, Ohio, United States, 43205

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97201

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Canada, Manitoba

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, Canada, MB R3E 3P4

Sponsors and Collaborators

Children's Hospital of Philadelphia

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

Investigators

• Principal Investigator: Susan Furth, MD; Children's Hospital of Philadelphia

More Information

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT03842293
• Other Study ID Numbers: 17-013723; 1U19AR069525 ( U.S. NIH Grant/Contract )
• First Posted: February 15, 2019
• Last Update Posted: November 27, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency