- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03714230
Longitudinal Prospective Study in a Mixed ICU Population
The Trajectory of Functional Status During the First Year After ICU Admission.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Oslo, Norge, 0424
- Oslo Univesity hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
A cohort study on change of Functional Status during the first year after an ICU admission
Tidsramme: September 2018- May 2020
|
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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The investigation of 5 pre-selected symptoms during the ICU stay
Tidsramme: 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.
|
September 2018 - December 2020
|
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Cognitive functioning one year after ICU admission in a mixed ICU population
Tidsramme: 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
Tidsramme: 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.
|
January 2020 - December 2021
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tone Rustøen, Professor, Oslo University Hospital and Oslo University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2017/990
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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