Longitudinal Prospective Study in a Mixed ICU Population

Completed

• Conditions: Intensive Care Patients

• Registration Number: NCT03714230
• Lead Sponsor: Oslo University Hospital

Brief Summary

Longitudinal prospective observational multicenter study in a mixed population of intensive care unit (ICU) patients (n=650). The overall purpose of this research proposal is to increase the knowledge in how pre-morbid condition, symptoms during treatment, and selected clinical variables affect self-reported functional status during first year after an ICU admission.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2018-09-26
• Study Start: 2018-10-08
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Status Verified: 2021-04
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 603

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A cohort study on change of Functional Status during the first year after an ICU admission	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.

Secondary Outcome Measures

Name	Time	Method
The investigation of 5 pre-selected symptoms during the ICU stay	September 2018 - December 2020	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.
Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope	January 2020 - December 2021	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.
Cognitive functioning one year after ICU admission in a mixed ICU population	September 2018 - December 2020	Cognitive functioning will be measured using self-report with the Cognitive Failure Questionnaire, and proxy reported by IQCODE and CFQ at baseline.

Trial Locations

Locations (1)

Oslo Univesity hospital; 🇳🇴 Oslo, Norway