- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03714230
Longitudinal Prospective Study in a Mixed ICU Population
The Trajectory of Functional Status During the First Year After ICU Admission.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
For this study data will be collected using self-report questionnaires for the long-term outcome (e.g functional status) and several covariates (e.g., cognition, anxiety and depression, PTSD, QOL, general symptoms, frailty). To retrieve baseline data from prior ICU admission, family members will be used as proxy reporters at inclusion. During treatment in the ICU, patients will be mapped for 5 pre-selected symptoms every day for 7 days, or until death or ICU discharge. Several clinical variables (e.g., SOFA score, pain score, level of sedation, mobilization, medication, mouth care) will be collected daily until maximum 7 days. Follow-up data will be collected at 3, 6 and 12 months after ICU admission using self-report questionnaires.
The predictive value of pre-morbid condition prior to ICU admission on functional status during the first year after an ICU admission will be investigated, when controlled for various clinical and demographic variables. As a secondary analyses, the present study will identify both the occurrence of symptoms as well as the severity and distress of each symptom, while in the ICU. Another secondary outcome that will be measured in this longitudinal study is the association between cognitive function one year after an ICU admission and various mental health variables (PTSD, anxiety and depression).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Oslo, Noruega, 0424
- Oslo Univesity hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria
- Patients that are > 18 years and
- Meet the criteria of Norwegian Intensive Register (NIR) for being an intensive care patient. The criteria include any on the following criteria:
- The need of mechanical ventilation, or
- The need of continuous inotropi, or
- 24 hours or more on an ICU, when continuous monitoring is needed, or
- Dies at the ICU within the first 24 hours, or
- Transferred to another ICU within the first 24 hours
Exclusion Criteria:
- Re-admissions to the ICU (within 72 hours from last ICU discharge)
- Pre-defined cognitive deficit (e.g. dementia)
- Homeless
- Unable to read and Write Norwegian
- Not included in the study within the first 48 hours since admission to the ICU
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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A cohort study on change of Functional Status during the first year after an ICU admission
Periodo de tiempo: September 2018- May 2020
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Data on functional status will be collected using PROMS (e.g
Katz index and Lawton IADL) at baseline, and then after 3, 6 and 12 months.
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September 2018- May 2020
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The investigation of 5 pre-selected symptoms during the ICU stay
Periodo de tiempo: September 2018 - December 2020
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A modified version of the Patient Symptom Survey (PSS) checklist will be used as self-report by the ICU patient when possible or by the clinical nurse as a proxy reporter.
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September 2018 - December 2020
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Cognitive functioning one year after ICU admission in a mixed ICU population
Periodo de tiempo: September 2018 - December 2020
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Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire, and proxy reported by IQCODE and CFQ at baseline.
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September 2018 - December 2020
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Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope
Periodo de tiempo: January 2020 - December 2021
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Posttraumatic stress symptoms will be measured using self-report with the Impact of event scale-revised questionnaire.
Hope will be measured with the Herth Hope Index.
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January 2020 - December 2021
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tone Rustøen, Professor, Oslo University Hospital and Oslo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2017/990
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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