- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286439
Recovery After Medical or Surgical Treatment
Recovery After Medical or Surgical Treatment - A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Køge, Denmark, 4600
- Zealand University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: 3 months after discharge
|
Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)
|
3 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months after discharge
|
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 months after discharge
|
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.
|
3 months after discharge
|
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.
|
12 months after discharge
|
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.
|
3 months after discharge
|
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
|
12 months after discharge
|
Mortality
Time Frame: 90 days after discharge
|
The mortality of the patients within 90 days after hospital discharge.
|
90 days after discharge
|
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
|
90 days after discharge
|
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
|
90 days after discharge
|
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
|
90 days after discharge
|
Sleepiness
Time Frame: At inclusion
|
This will be investigated by filling out Epworth Sleepiness Scale
|
At inclusion
|
Sleepiness
Time Frame: 3 months after discharge
|
This will be investigated by filling out Epworth Sleepiness Scale
|
3 months after discharge
|
Sleepiness
Time Frame: 12 months after discharge
|
This will be investigated by filling out Epworth Sleepiness Scale
|
12 months after discharge
|
Insomnia
Time Frame: At inclusion
|
This will be investigated by filling out Insomnia Severity Index
|
At inclusion
|
Insomnia
Time Frame: 3 months after discharge
|
This will be investigated by filling out Insomnia Severity Index
|
3 months after discharge
|
Insomnia
Time Frame: 12 months after discharge
|
This will be investigated by filling out Insomnia Severity Index
|
12 months after discharge
|
Sleep Quality
Time Frame: At inclusion
|
This will be investigated by filling out Pittsburgh Sleep Quality Index
|
At inclusion
|
Sleep Quality
Time Frame: 3 months after discharge
|
This will be investigated by filling out Pittsburgh Sleep Quality Index
|
3 months after discharge
|
Sleep Quality
Time Frame: 12 months after discharge
|
This will be investigated by filling out Pittsburgh Sleep Quality Index
|
12 months after discharge
|
Information processing speed
Time Frame: 3 months after discharge
|
This will be investigated by filling out the Trail Making Test Part A
|
3 months after discharge
|
Information processing speed
Time Frame: 12 months after discharge
|
This will be investigated by filling out the Trail Making Test Part A
|
12 months after discharge
|
Executive function
Time Frame: 3 months after discharge
|
This will be investigated by filling out the Trail Making Test Part B
|
3 months after discharge
|
Executive function
Time Frame: 12 months after discharge
|
This will be investigated by filling out the Trail Making Test Part B
|
12 months after discharge
|
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
|
12 months
|
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
|
At inclusion
|
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
|
90 days after discharge
|
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
|
12 months after discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stine Estrup, MD, Stine Estrup
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA-1-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Deficit
-
University of ArizonaBanner HealthCompletedCognitive Deficit | Distorted; Balance | Motor DeficitUnited States
-
University of Texas at AustinRecruitingAttention Deficit Hyperactivity Disorder | Cognitive Deficit | Wellness | Attention Difficulties | Attention DeficitUnited States
-
FH Joanneum Gesellschaft mbHAustrian Research Promotion AgencyRecruiting
-
University of CincinnatiRecruitingStudying the Effects of Brain Stimulation on Cognitive Control and Associated EEG in Human Subjects.Cognitive DeficitUnited States
-
University of MichiganRecruiting
-
Azienda Ospedaliero-Universitaria di ParmaActive, not recruitingCognitive Deficit | DysglycemiaItaly
-
MoCA Clinic and InstituteActive, not recruitingCognitive Impairment | Cognitive Change | Cognitive Deficit | Assessment, SelfCanada
-
Biruni UniversityCompletedADHD | Cognitive DeficitTurkey
-
Charite University, Berlin, GermanyActive, not recruitingNeurocognitive Disorders | Postoperative Cognitive Deficit (POCD)Germany
-
Hacettepe UniversityAnkara Medipol UniversityRecruitingSocial Skills | Motor Activity | Emotional Regulation | Attention Deficit Disorder With Hyperactivity | Cognitive Deficit in Attention | Sensory Integration Disorder | Behavior HyperactiveTurkey
Clinical Trials on there will be offered a follow up visit
-
Hospital for Special Surgery, New YorkAgency for Healthcare Research and Quality (AHRQ)Active, not recruiting
-
Ayse YilmazEnrolling by invitation
-
Cumhuriyet UniversityNot yet recruitingDIALYSIS SYMPTOMS AND ANXIETYTurkey
-
City of Hope Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Icahn...Recruiting
-
University of AberdeenKellogg CompanyCompletedBio-availability of Wheat Bran Phytochemicals in the Human Gut | Bio-availability of Wheat Bran Phytochemicals for the Systemic CirculationUnited Kingdom
-
Memorial Sloan Kettering Cancer CenterCompletedCervical Cancer | Rectal Cancer | Endometrial Cancer | Anal CancerUnited States
-
The University of Texas Health Science Center,...WithdrawnA Pilot Randomized Trial of a Comprehensive Transitional Care Program for Colorectal Cancer PatientsColorectal Cancer | Comprehensive Transitional Care ProgramUnited States
-
Providence Health & ServicesTerminated
-
Nantes University HospitalCompletedProton Pump Inhibitors | DeprescriptionFrance
-
Hacettepe UniversityActive, not recruitingNeural Tube Defects | Newborn MorbidityTurkey