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Clinical Evaluation of PROMIS in CKD

25 de novembro de 2020 atualizado por: Children's Hospital of Philadelphia

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

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.

Visão geral do estudo

Status

Concluído

Condições

Doenças Renais Crônicas

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

213

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Canadá
- Manitoba
  - Winnipeg, Manitoba, Canadá, MB R3E 3P4
    - Children's Hospital Research Institute of Manitoba
Estados Unidos
- Alabama
  - Birmingham, Alabama, Estados Unidos, 35205
    - Children's Hospital of Alabama
- California
  - Los Angeles, California, Estados Unidos, 90095
    - UCLA
- Georgia
  - Atlanta, Georgia, Estados Unidos, 30322
    - Children's Healthcare of Atlanta
- Indiana
  - Indianapolis, Indiana, Estados Unidos, 46202
    - Riley Hospital for Children
- Maryland
  - Baltimore, Maryland, Estados Unidos, 21287
    - Johns Hopkins Children's Center
- Michigan
  - Ann Arbor, Michigan, Estados Unidos, 48109
    - University of Michigan, Mott Hospital
- Missouri
  - Kansas City, Missouri, Estados Unidos, 64108
    - Children's Mercy Hospital
  - Saint Louis, Missouri, Estados Unidos, 63110
    - St. Louis Children's Hospital
- North Carolina
  - Charlotte, North Carolina, Estados Unidos, 28203
    - Levine Children's
- Ohio
  - Cincinnati, Ohio, Estados Unidos, 45229
    - Cincinnati Children's Hospital and Medical Center
  - Cleveland, Ohio, Estados Unidos, 44195
    - Cleveland Clinic
  - Columbus, Ohio, Estados Unidos, 43205
    - Nationwide Children's Hopsital
- Oregon
  - Portland, Oregon, Estados Unidos, 97201
    - Oregon Health and Science University
- Pennsylvania
  - Philadelphia, Pennsylvania, Estados Unidos, 19104
    - Children's Hospital of Philadelphia
- Washington
  - Seattle, Washington, Estados Unidos, 98105
    - Seattle Children's Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

8 anos a 21 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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).

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: Coorte
Perspectivas de Tempo: Prospectivo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Longitudinal change in sleep disturbance Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in sleep-related impairment Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in fatigue Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in life satisfaction Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in meaning and purpose Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in psychological stress experiences Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in global health Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in depressive symptoms Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in anxiety Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in positive affect Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
Longitudinal change in family relationships Prazo: 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.	Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Children's Hospital of Philadelphia

Colaboradores

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

Investigadores

Investigador principal: Susan Furth, MD, Children's Hospital of Philadelphia

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

22 de junho de 2017

Conclusão Primária (Real)

30 de agosto de 2020

Conclusão do estudo (Real)

30 de agosto de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

13 de fevereiro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ