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Completed

NCT Number: NCT03286439

Recovery After Medical or Surgical Treatment

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital

Køge, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

there will be offered a follow up visit

Other

The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.

Primary outcomes

  1. Cognitive function

    Time frame: 3 months after discharge

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

Secondary outcomes

  1. Cognitive function after one year

    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

  2. Rehabilitation after 3 months

    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

  3. Self-reported health related quality of life

    Time frame: 3 months after discharge

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

  4. Self-reported health related quality of life

    Time frame: 12 months after discharge

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

  5. Objective assessment of physical function

    Time frame: 3 months after discharge

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

  6. Objective assessment of physical function

    Time frame: 12 months after discharge

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

  7. Mortality

    Time frame: 90 days after discharge

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

  8. Consumption of opioids

    Time frame: 90 days after discharge

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

  9. Consumption of statins 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

  10. Consumption of anti-depressants

    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

  11. Sleepiness

    Time frame: At inclusion

    This will be investigated by filling out Epworth Sleepiness Scale

  12. Sleepiness

    Time frame: 3 months after discharge

    This will be investigated by filling out Epworth Sleepiness Scale

  13. Sleepiness

    Time frame: 12 months after discharge

    This will be investigated by filling out Epworth Sleepiness Scale

  14. Insomnia

    Time frame: At inclusion

    This will be investigated by filling out Insomnia Severity Index

  15. Insomnia

    Time frame: 3 months after discharge

    This will be investigated by filling out Insomnia Severity Index

  16. Insomnia

    Time frame: 12 months after discharge

    This will be investigated by filling out Insomnia Severity Index

  17. Sleep Quality

    Time frame: At inclusion

    This will be investigated by filling out Pittsburgh Sleep Quality Index

  18. Sleep Quality

    Time frame: 3 months after discharge

    This will be investigated by filling out Pittsburgh Sleep Quality Index

  19. Sleep Quality

    Time frame: 12 months after discharge

    This will be investigated by filling out Pittsburgh Sleep Quality Index

  20. Information processing speed

    Time frame: 3 months after discharge

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

  21. Information processing speed

    Time frame: 12 months after discharge

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

  22. Executive function

    Time frame: 3 months after discharge

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

  23. Executive function

    Time frame: 12 months after discharge

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

  24. Rehabilitation after 12 months

    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

  25. Consumption of sleep medication

    Time frame: At inclusion

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

  26. Consumption of sleep medication

    Time frame: 90 days after discharge

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

  27. Consumption of sleep medication

    Time frame: 12 months after discharge

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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Recovery After Medical or Surgical Treatment - A Prospective Cohort Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2017
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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