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Clinical Evaluation of PROMIS in CKD

25 ноября 2020 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Хронические заболевания почек

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

213

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 8 лет до 21 год (Ребенок, Взрослый)

Принимает здоровых добровольцев

Н/Д

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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).

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Наблюдательные модели: Когорта
Временные перспективы: Перспективный

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Longitudinal change in sleep disturbance Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Children's Hospital of Philadelphia

Соавторы

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

Следователи

Главный следователь: Susan Furth, MD, Children's Hospital of Philadelphia

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

22 июня 2017 г.

Первичное завершение (Действительный)

30 августа 2020 г.

Завершение исследования (Действительный)

30 августа 2020 г.

Даты регистрации исследования

Первый отправленный

13 февраля 2019 г.

Впервые представлено, что соответствует критериям контроля качества