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Clinical Evaluation of PROMIS in CKD

2020. november 25. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Krónikus vesebetegségek

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

213

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

8 év (Gyermek, Felnőtt)

Egészséges önkénteseket fogad

N/A

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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).

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: Kohorsz
Időperspektívák: Leendő

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Longitudinal change in sleep disturbance Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Children's Hospital of Philadelphia

Együttműködők

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

Nyomozók

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

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2017. június 22.

Elsődleges befejezés (Tényleges)

2020. augusztus 30.

A tanulmány befejezése (Tényleges)

2020. augusztus 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2019. február 13.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak