Recovery After Medical or Surgical Treatment

Cognitive Deficit Clinical Trial

Official title:

Recovery After Medical or Surgical Treatment - A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286439
• Other study ID #: NA-1-2017
• Status: Completed
• Start date: November 13, 2017
• Est. completion date: July 6, 2018

Study information

• Verified date: September 2018
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Cognitive Dysfunction

Intervention

Other:
• there will be offered a follow up visit
The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)	3 months after discharge
Secondary	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	12 months after discharge
Secondary	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	3 months after discharge
Secondary	Self-reported health related quality of life	This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.	3 months after discharge
Secondary	Self-reported health related quality of life	This will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.	12 months after discharge
Secondary	Objective assessment of physical function	This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool.	3 months after discharge
Secondary	Objective assessment of physical function	This will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool	12 months after discharge
Secondary	Mortality	The mortality of the patients within 90 days after hospital discharge.	90 days after discharge
Secondary	Consumption of opioids	Percentage of patients with a daily consumption of opioids at hospital admission and 90 days after discharge	90 days after discharge
Secondary	Consumption of statins days after discharge	Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge	90 days after discharge
Secondary	Consumption of anti-depressants	Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge	90 days after discharge
Secondary	Sleepiness	This will be investigated by filling out Epworth Sleepiness Scale	At inclusion
Secondary	Sleepiness	This will be investigated by filling out Epworth Sleepiness Scale	3 months after discharge
Secondary	Sleepiness	This will be investigated by filling out Epworth Sleepiness Scale	12 months after discharge
Secondary	Insomnia	This will be investigated by filling out Insomnia Severity Index	At inclusion
Secondary	Insomnia	This will be investigated by filling out Insomnia Severity Index	3 months after discharge
Secondary	Insomnia	This will be investigated by filling out Insomnia Severity Index	12 months after discharge
Secondary	Sleep Quality	This will be investigated by filling out Pittsburgh Sleep Quality Index	At inclusion
Secondary	Sleep Quality	This will be investigated by filling out Pittsburgh Sleep Quality Index	3 months after discharge
Secondary	Sleep Quality	This will be investigated by filling out Pittsburgh Sleep Quality Index	12 months after discharge
Secondary	Information processing speed	This will be investigated by filling out the Trail Making Test Part A	3 months after discharge
Secondary	Information processing speed	This will be investigated by filling out the Trail Making Test Part A	12 months after discharge
Secondary	Executive function	This will be investigated by filling out the Trail Making Test Part B	3 months after discharge
Secondary	Executive function	This will be investigated by filling out the Trail Making Test Part B	12 months after discharge
Secondary	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	12 months
Secondary	Consumption of sleep medication	Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge	At inclusion
Secondary	Consumption of sleep medication	Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge	90 days after discharge
Secondary	Consumption of sleep medication	Percentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge	12 months after discharge