Recovery After Medical or Surgical Treatment

September 23, 2018 updated by: Stine Estrup, Zealand University Hospital

Recovery After Medical or Surgical Treatment - A Prospective Cohort Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population consists of critically ill patients that have been admitted to surgical or Medical departement.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stine Estrup, MD, Stine Estrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NA-1-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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