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Clinical Evaluation of PROMIS in CKD

25 november 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Kroniska njursjukdomar

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

213

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

8 år till 21 år (Barn, Vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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).

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: Kohort
Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Longitudinal change in sleep disturbance Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Hospital of Philadelphia

Samarbetspartners

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

Utredare

Huvudutredare: Susan Furth, MD, Children's Hospital of Philadelphia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 juni 2017

Primärt slutförande (Faktisk)

30 augusti 2020

Avslutad studie (Faktisk)

30 augusti 2020

Studieregistreringsdatum

Först inskickad

13 februari 2019

Först inskickad som uppfyllde QC-kriterierna