Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Clinical Evaluation of PROMIS in CKD

25. november 2020 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Kroniske nyresykdommer

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

213

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 21 år (Barn, Voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Longitudinal change in sleep disturbance Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Hospital of Philadelphia

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. juni 2017

Primær fullføring (Faktiske)

30. august 2020

Studiet fullført (Faktiske)

30. august 2020

Datoer for studieregistrering

Først innsendt

13. februar 2019

Først innsendt som oppfylte QC-kriteriene