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Clinical Evaluation of PROMIS in CKD

25 listopada 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

213

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

8 lat do 21 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie dotyczy

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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).

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Kohorta
  • Perspektywy czasowe: Spodziewany

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Longitudinal change in sleep disturbance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Children's Hospital of Philadelphia

Współpracownicy

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

Śledczy

  • Główny śledczy: Susan Furth, MD, Children's Hospital of Philadelphia

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 czerwca 2017

Zakończenie podstawowe (Rzeczywisty)

30 sierpnia 2020

Ukończenie studiów (Rzeczywisty)

30 sierpnia 2020

Daty rejestracji na studia

Pierwszy przesłany

13 lutego 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 lutego 2019

Pierwszy wysłany (Rzeczywisty)

15 lutego 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 listopada 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 listopada 2020

Ostatnia weryfikacja

1 listopada 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 17-013723
  • 1U19AR069525 (Grant/umowa NIH USA)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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