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Clinical Evaluation of PROMIS in CKD

25. November 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

213

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

8 Jahre bis 21 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

N/A

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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).

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Longitudinal change in sleep disturbance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Children's Hospital of Philadelphia

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Juni 2017

Primärer Abschluss (Tatsächlich)

30. August 2020

Studienabschluss (Tatsächlich)

30. August 2020

Studienanmeldedaten

Zuerst eingereicht

13. Februar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Februar 2019

Zuerst gepostet (Tatsächlich)

15. Februar 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. November 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. November 2020

Zuletzt verifiziert

1. November 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 17-013723
  • 1U19AR069525 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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