Cognitive Function and Health-related Quality of Life After Neuro-intensive Care

Study Overview
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Brief Summary
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The study will provide information on cognitive impairment and Health related quality of life in patients surviving 12 months after acute brain injury, generate a hypothesis of useful variables to predict cognitive impairment or low levels of HRQoL, and potentially inform interventions for the prevention and treatment of cognitive impairment following neuro-ICU stay.

Detailed Description
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The aim is to 1) measure the frequency and extent of cognitive impairment after acute brain injury at six and 12-months after neuro-Intensive care unit (ICU) admission 2) explore the association between cognitive impairment at six and 12 months after ICU admission with the following potential risk factors: duration of ICU delirium (days), duration of sepsis (days), duration of post traumatic amnesia (days) and the severity of brain injury (initial Glasgow Coma Scale , 3) describe Health related quality of life, functional disability and frailty at six and 12 after ICU admission and 4) explore the association between the functional disability, frailty and health-related quality of life at 12 months after ICU admission

Official Title
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Cognitive Function and Health-related Quality of Life After Neuro-intensive Care: An Observational Multicenter Cohort Study

Conditions
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Acute Brain Injury, Cognitive Dysfunction, Delirium, Sepsis, Post-traumatic Amnesia, Health-related Quality of Life

Intervention / Treatment
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* Behavioral: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic brain injury Spontaneous intracranial hemorrhage Ischemic stroke An anticipated stay in the neuro-ICU for 48 hours or longer. Exclusion Criteria: Persistent coma defined as Richmond Agitation-Sedation Scale (RASS) -5 to -3 throughout the neuro-ICU stay Congenital brain injury Suspected pre-existing Cognitive impairment (Informant Questionnaire on cognitive decline in the elderly (IQCODE): 3.3 or more) (regardless of cause) Permanent residence outside Denmark Inability to communicate in Danish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: no intervention|no intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Global cognitive function | measured by The Repeatable Battery for the Assessment of Neuropsychological Status, Overall score (mean 100; SD=15). Higher scores indicate better cognitive functioning. | from baseline to 6 months after ICU admission | 
| Change in Global cognitive function | measured by The Repeatable Battery for the Assessment of Neuropsychological Status, Overall score (mean 100; SD=15). Higher scores indicate better cognitive functioning. | from baseline to 12 months after ICU admission | 
| Change in Executive function | measured by Trail Making Test B, Score indicate time in seconds to complete task, the higher speed (less seconds) indicates higher executive function | from baseline to 6 months after ICU admission | 
| Change in Executive function | measured by Trail Making Test B, Score indicate time in seconds to complete task, the higher speed (less seconds) indicates higher executive function | from baseline to 12 months after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health related quality of life after brain injury | measured with a disease specific questionnaire:Quality of Life after Brain Injury overall scale (QOLIBRI-OS). Scores are from 0-100, the higher the score the more quality of life. | from baseline to 6 months after ICU admission | 
| Change in Health related quality of life after brain injury | measured with a disease specific questionnaire:Quality of Life after Brain Injury overall scale (QOLIBRI-OS). Scores are from 0-100, the higher the score the more quality of life. | from baseline to 12 months after ICU admission | 
| Delirium | measured by Confusion measured by CAM-ICU or Intensive Care Delirium Screening Checklist (ICDSC). | during the procedure (ICU stay) up to 30 days | 
| Change in Disability after head injury/nontraumatic acute brain insults I | measured by Glasgow outcome scale extended (GOSE). Scores from 1 to 8, higher scores indicate less disability | from baseline to 6 months after ICU admission | 
| Change in Disability after head injury/nontraumatic acute brain insults I | measured by Glasgow outcome scale extended (GOSE). Scores from 1 to 8, higher scores indicate less disability | from baseline to 12 months after ICU admission | 
| Change in Disability after head injury/nontraumatic acute brain insults II | measured by Extended disability rating scale (DRS). Scores from 0 to 29, the higher the score the more disability | from baseline to 6 months after ICU admission | 
| Change in Disability after head injury/nontraumatic acute brain insults II | measured by Extended disability rating scale (DRS). Scores from 0 to 29, the higher the score the more disability | from baseline to 12 months after ICU admission | 
| Change in Frailty | measured by the Clinical Frailty Scale (CFS). Scale is from 1 to 9 ( the higher score the more frail). | baseline to 6 months after ICU admission | 
| Change in Frailty | measured by the Clinical Frailty Scale (CFS). Scale is from 1 to 9 ( the higher score the more frail). | baseline to 12 months after ICU admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute brain injury after intensive care unit care