An observational study in Cognitive Deficit, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by Zealand University Hospital · Observational
This study aims to investigate the in-hospital care as well as the cognitive status, quality of life, physical function and risk of anxiety and depression, sleep disorders and drug use in a Danish cohort of both medical and surgical patients with acute critical illness without admittance to ICU (Intensive Care Unit) treatment, at three and twelve months after hospital discharge.
A stay at the ICU (intensive Care Unit) is related to life-threatening conditions and often displays a major impact on both physical and mental resources of the patients. Studies show that a great part of ICU patients have impairments of both physical and psychological kinds, some long-lasting. This condition is termed the "post intensive care syndrome" (PICS) and describes a wide range of symptoms as fatigue, depression, anxiety, memory loss along with both cognitive and physical impairments. Rehabilitative efforts are, thus, needed, and it has been suggested that ideally, rehabilitation should begin at the time of admission to the hospital and continue for a long time, possibly years, after the patient has been discharged. Regarding long term cognitive function of the ICU survivors in particular, recent studies have demonstrated severe impairment at the level of light Alzheimer's disease. In all of these studies, the reference group is the normal population, and it is a general problem that the cognitive and physical function of ICU patients before critical illness is unknown. There has recently been a norwegian study that included a reference group of surgical patients undergoing major surgery. The surgical group was older and more severely ill than the ICU group and was found to have a much worse cognitive function. Moreover, the cognitive function of the critically ill patients was not very far from the normal reference population due to selection.
To determine to which degree the impairments can be attributed to ICU-admission, the investigators need to look at a hospitalised and representative, non-ICU population, which is what will be done in the study. The investigators will therefore include patients that have been admitted to surgical or medical department acute without admittance to the ICU and contact these patients 3 and 12 months after admission. Where there will be performed different tests in order to evaluate the the cognitive status, quality of life, physical function and risk of anxiety and depression, sleep disorders and drug use.
The study population consists of critically ill patients that have been admitted to surgical or Medical departement.
Admitted with one of the following diagnoses:
Exclusion Criteria:
The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.
Cognitive function
Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)
Time frame: 3 months after discharge
Cognitive function after one year
Cognitive function measured with The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation at 12 months after discharge from hospital
Time frame: 12 months after discharge
Rehabilitation after 3 months
This will be investigated by filling out a checklist of community support and contact to health care system at 3 month follow up
Time frame: 3 months after discharge
Self-reported health related quality of life
This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.
Time frame: 3 months after discharge
Self-reported health related quality of life
This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.
Time frame: 12 months after discharge
Objective assessment of physical function
This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool.
Time frame: 3 months after discharge
Objective assessment of physical function
This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool
Time frame: 12 months after discharge
Mortality
The mortality of the patients within 90 days after hospital discharge.
Time frame: 90 days after discharge
Consumption of opioids
Percentage of patients with a daily consumption of opioids at hospital admission and 90 days after discharge
Time frame: 90 days after discharge
Consumption of statins days after discharge
Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge
Time frame: 90 days after discharge
Consumption of anti-depressants
Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge
Time frame: 90 days after discharge
Sleepiness
This will be investigated by filling out Epworth Sleepiness Scale
Time frame: At inclusion
Sleepiness
This will be investigated by filling out Epworth Sleepiness Scale
Time frame: 3 months after discharge
Sleepiness
This will be investigated by filling out Epworth Sleepiness Scale
Time frame: 12 months after discharge
Insomnia
This will be investigated by filling out Insomnia Severity Index
Time frame: At inclusion
Insomnia
This will be investigated by filling out Insomnia Severity Index
Time frame: 3 months after discharge
Insomnia
This will be investigated by filling out Insomnia Severity Index
Time frame: 12 months after discharge
Sleep Quality
This will be investigated by filling out Pittsburgh Sleep Quality Index
Time frame: At inclusion
Sleep Quality
This will be investigated by filling out Pittsburgh Sleep Quality Index
Time frame: 3 months after discharge
Sleep Quality
This will be investigated by filling out Pittsburgh Sleep Quality Index
Time frame: 12 months after discharge
Information processing speed
This will be investigated by filling out the Trail Making Test Part A
Time frame: 3 months after discharge
Information processing speed
This will be investigated by filling out the Trail Making Test Part A
Time frame: 12 months after discharge
Executive function
This will be investigated by filling out the Trail Making Test Part B
Time frame: 3 months after discharge
Executive function
This will be investigated by filling out the Trail Making Test Part B
Time frame: 12 months after discharge
Rehabilitation after 12 months
This will be investigated by filling out a checklist of Community support and contact to health care system at 3 month follow up
Time frame: 12 months
Consumption of sleep medication
Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
Time frame: At inclusion
Consumption of sleep medication
Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
Time frame: 90 days after discharge
Consumption of sleep medication
Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
Time frame: 12 months after discharge
Plan to share: No
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Zealand University Hospital