Zealand University Hospital
Køge, 4600, Denmark
NCT Number: NCT03286439
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.
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Notify Me18 year and older
All sexes
Observational
Køge, 4600, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.
Time frame: 3 months after discharge
Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)
Time frame: 12 months after discharge
Cognitive function measured with The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation at 12 months after discharge from hospital
Time frame: 3 months after discharge
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
This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.
Time frame: 12 months after discharge
This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.
Time frame: 3 months after discharge
This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool.
Time frame: 12 months after discharge
This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool
Time frame: 90 days after discharge
The mortality of the patients within 90 days after hospital discharge.
Time frame: 90 days after discharge
Percentage of patients with a daily consumption of opioids at hospital admission and 90 days after discharge
Time frame: 90 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
Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge
Time frame: At inclusion
This will be investigated by filling out Epworth Sleepiness Scale
Time frame: 3 months after discharge
This will be investigated by filling out Epworth Sleepiness Scale
Time frame: 12 months after discharge
This will be investigated by filling out Epworth Sleepiness Scale
Time frame: At inclusion
This will be investigated by filling out Insomnia Severity Index
Time frame: 3 months after discharge
This will be investigated by filling out Insomnia Severity Index
Time frame: 12 months after discharge
This will be investigated by filling out Insomnia Severity Index
Time frame: At inclusion
This will be investigated by filling out Pittsburgh Sleep Quality Index
Time frame: 3 months after discharge
This will be investigated by filling out Pittsburgh Sleep Quality Index
Time frame: 12 months after discharge
This will be investigated by filling out Pittsburgh Sleep Quality Index
Time frame: 3 months after discharge
This will be investigated by filling out the Trail Making Test Part A
Time frame: 12 months after discharge
This will be investigated by filling out the Trail Making Test Part A
Time frame: 3 months after discharge
This will be investigated by filling out the Trail Making Test Part B
Time frame: 12 months after discharge
This will be investigated by filling out the Trail Making Test Part B
Time frame: 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: At inclusion
Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
Time frame: 90 days after discharge
Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
Time frame: 12 months after discharge
Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
Zealand University Hospital
Other
Recovery After Medical or Surgical Treatment - A Prospective Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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