MedPath

Recovery After Medical or Surgical Treatment

Completed
Conditions
Cognitive Deficit
Registration Number
NCT03286439
Lead Sponsor
Zealand University Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
101
Inclusion Criteria
  • Patients > 18 years of age

  • Admitted to surgical or medical department > 3 days

  • Admitted with one of the following diagnoses:

    • Pneumonia
    • Heart failure
    • Pulmonary embolism
    • Acute myocardial infarction
    • Pyelonephritis
    • Patients undergoing non-elective open or laparoscopic abdominal surgery (not including elective procedures, diseases of the appendix, diseases of the gallbladder, liver, spleen, kidney, pancreas and emergency hernia surgery without bowel resection)
Exclusion Criteria
  • Permanently incompetent patients not able to consent
  • Not able to speak and understand Danish
  • Discharged from the hospital for terminal care
  • Patients transferred to another hospital during the stay
  • Patients living outside the Region of Zealand
  • Patients admitted under duress or actively psychotic
  • Patients that are blind or severely visually impaired.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cognitive function3 months after discharge

Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)

Secondary Outcome Measures
NameTimeMethod
Information processing speed12 months after discharge

This will be investigated by filling out the Trail Making Test Part A

Cognitive function after one year12 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

Rehabilitation after 3 months3 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

Self-reported health related quality of life12 months after discharge

This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.

Objective assessment of physical function12 months after discharge

This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool

Mortality90 days after discharge

The mortality of the patients within 90 days after hospital discharge.

Consumption of opioids90 days after discharge

Percentage of patients with a daily consumption of opioids at hospital admission and 90 days after discharge

Consumption of statins days after discharge90 days after discharge

Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge

Consumption of anti-depressants90 days after discharge

Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge

Sleepiness12 months after discharge

This will be investigated by filling out Epworth Sleepiness Scale

Insomnia12 months after discharge

This will be investigated by filling out Insomnia Severity Index

Sleep Quality12 months after discharge

This will be investigated by filling out Pittsburgh Sleep Quality Index

Executive function12 months after discharge

This will be investigated by filling out the Trail Making Test Part B

Rehabilitation after 12 months12 months

This will be investigated by filling out a checklist of Community support and contact to health care system at 3 month follow up

Consumption of sleep medication12 months after discharge

Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge

Trial Locations

Locations (1)

Zealand University Hospital

🇩🇰

Køge, Denmark

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