Clinical Evaluation of PROMIS in CKD
25 de noviembre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
213
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, MB R3E 3P4
- Children's Hospital Research Institute of Manitoba
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Children's Hospital of Alabama
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Children's Healthcare of Atlanta
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Riley Hospital for Children
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Children's Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan, Mott Hospital
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28203
- Levine Children's
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital and Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Columbus, Ohio, Estados Unidos, 43205
- Nationwide Children's Hopsital
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Oregon
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Portland, Oregon, Estados Unidos, 97201
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Seattle Children's Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
8 años a 21 años (Niño, Adulto)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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).
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Longitudinal change in sleep disturbance
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in sleep-related impairment
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in fatigue
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in life satisfaction
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in meaning and purpose
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in psychological stress experiences
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in global health
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in depressive symptoms
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in anxiety
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in positive affect
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Longitudinal change in family relationships
Periodo de tiempo: Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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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.
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Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Susan Furth, MD, Children's Hospital of Philadelphia
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de junio de 2017
Finalización primaria (Actual)
30 de agosto de 2020
Finalización del estudio (Actual)
30 de agosto de 2020
Fechas de registro del estudio
Enviado por primera vez
13 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
13 de febrero de 2019
Publicado por primera vez (Actual)
15 de febrero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
25 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 17-013723
- 1U19AR069525 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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