此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Clinical Evaluation of PROMIS in CKD

2020年11月25日 更新者：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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

213

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年 至 21年 (孩子、成人)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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).

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：队列
  • 时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Longitudinal change in sleep disturbance
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Children's Hospital of Philadelphia

合作者

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

调查人员

  • 首席研究员：Susan Furth, MD、Children's Hospital of Philadelphia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年6月22日

初级完成 (实际的)

2020年8月30日

研究完成 (实际的)

2020年8月30日

研究注册日期

首次提交

2019年2月13日

首先提交符合 QC 标准的

2019年2月13日

首次发布 (实际的)

2019年2月15日

研究记录更新

最后更新发布 (实际的)

2020年11月27日

上次提交的符合 QC 标准的更新

2020年11月25日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 17-013723
  • 1U19AR069525 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅