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Clinical Evaluation of PROMIS in CKD

25. listopadu 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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 studie

Pozorovací

Zápis (Aktuální)

213

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

8 let až 21 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

N/A

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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).

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Kohorta
  • Časové perspektivy: Budoucí

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Longitudinal change in sleep disturbance
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Children's Hospital of Philadelphia

Spolupracovníci

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

Vyšetřovatelé

  • Vrchní vyšetřovatel: Susan Furth, MD, Children's Hospital of Philadelphia

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

22. června 2017

Primární dokončení (Aktuální)

30. srpna 2020

Dokončení studie (Aktuální)

30. srpna 2020

Termíny zápisu do studia

První předloženo

13. února 2019

První předloženo, které splnilo kritéria kontroly kvality

13. února 2019

První zveřejněno (Aktuální)

15. února 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. listopadu 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. listopadu 2020

Naposledy ověřeno

1. listopadu 2020

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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