COGNI: Cognitive Function and Health-related Quality of Life After Neuro-intensive Care
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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
Study Design
Outcome Measures
Primary Outcome Measures
- Change in Global cognitive function [from baseline to 6 months after ICU admission]
measured by The Repeatable Battery for the Assessment of Neuropsychological Status, Overall score (mean 100; SD=15). Higher scores indicate better cognitive functioning.
- Change in Global cognitive function [from baseline to 12 months after ICU admission]
measured by The Repeatable Battery for the Assessment of Neuropsychological Status, Overall score (mean 100; SD=15). Higher scores indicate better cognitive functioning.
- Change in Executive function [from baseline to 6 months after ICU admission]
measured by Trail Making Test B, Score indicate time in seconds to complete task, the higher speed (less seconds) indicates higher executive function
- Change in Executive function [from baseline to 12 months after ICU admission]
measured by Trail Making Test B, Score indicate time in seconds to complete task, the higher speed (less seconds) indicates higher executive function
Secondary Outcome Measures
- Change in Health related quality of life after brain injury [from baseline to 6 months after ICU admission]
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.
- Change in Health related quality of life after brain injury [from baseline to 12 months after ICU admission]
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.
- Delirium [during the procedure (ICU stay) up to 30 days]
measured by Confusion measured by CAM-ICU or Intensive Care Delirium Screening Checklist (ICDSC).
- Change in Disability after head injury/nontraumatic acute brain insults I [from baseline to 6 months after ICU admission]
measured by Glasgow outcome scale extended (GOSE). Scores from 1 to 8, higher scores indicate less disability
- Change in Disability after head injury/nontraumatic acute brain insults I [from baseline to 12 months after ICU admission]
measured by Glasgow outcome scale extended (GOSE). Scores from 1 to 8, higher scores indicate less disability
- Change in Disability after head injury/nontraumatic acute brain insults II [from baseline to 6 months after ICU admission]
measured by Extended disability rating scale (DRS). Scores from 0 to 29, the higher the score the more disability
- Change in Disability after head injury/nontraumatic acute brain insults II [from baseline to 12 months after ICU admission]
measured by Extended disability rating scale (DRS). Scores from 0 to 29, the higher the score the more disability
- Change in Frailty [baseline to 6 months after ICU admission]
measured by the Clinical Frailty Scale (CFS). Scale is from 1 to 9 ( the higher score the more frail).
- Change in Frailty [baseline to 12 months after ICU admission]
measured by the Clinical Frailty Scale (CFS). Scale is from 1 to 9 ( the higher score the more frail).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Traumatic brain injury
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Spontaneous intracranial hemorrhage
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Ischemic stroke
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An anticipated stay in the neuro-ICU for 48 hours or longer.
Exclusion Criteria:
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Persistent coma defined as Richmond Agitation-Sedation Scale (RASS) -5 to -3 throughout the neuro-ICU stay
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Congenital brain injury
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Suspected pre-existing Cognitive impairment (Informant Questionnaire on cognitive decline in the elderly (IQCODE): 3.3 or more) (regardless of cause)
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Permanent residence outside Denmark
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Inability to communicate in Danish
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rigshospitalet, Denmark
- Aalborg University Hospital
- Aarhus University Hospital
- Odense University Hospital
Investigators
- Principal Investigator: Suzanne F Herling, Ph.D, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NNF 20OC0064760