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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis; Delirium; Cognitive Dysfunction; Acute Brain Injury; Health-related Quality of Life; Post-traumatic Amnesia
• Intervention / Treatment: Behavioral: no intervention

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with acute brain injury from traumatic brain injury, spontaneous intracranial hemorrhage, or ischemic stroke with a Neuro ICU stay

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; Aarhus University Hospital; Aalborg University Hospital
• Investigators: Principal Investigator: Suzanne F Herling, Ph.D, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Acute brain injury after intensive care unit care
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Memory Disorders; Brain Injuries; Cognitive Dysfunction; Amnesia
• Other Study ID Numbers: NNF 20OC0064760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No