Recovery After Medical or Surgical Treatment
1 other identifier
observational
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedStudy Start
First participant enrolled
November 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2018
CompletedSeptember 25, 2018
September 1, 2018
8 months
September 14, 2017
September 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive function
Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)
3 months after discharge
Secondary Outcomes (27)
Cognitive function after one year
12 months after discharge
Rehabilitation after 3 months
3 months after discharge
Self-reported health related quality of life
3 months after discharge
Self-reported health related quality of life
12 months after discharge
Objective assessment of physical function
3 months after discharge
- +22 more secondary outcomes
Interventions
The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.
Eligibility Criteria
The study population consists of critically ill patients that have been admitted to surgical or Medical departement.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zealand University Hospital
Køge, 4600, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stine Estrup, MD
Stine Estrup
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 14, 2017
First Posted
September 18, 2017
Study Start
November 13, 2017
Primary Completion
July 6, 2018
Study Completion
July 6, 2018
Last Updated
September 25, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share