Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04538469
Eligibility Criteria:
Arm 1
Inclusion Criteria:
* Length of stay within critical care \> 4 days
* Age \> 18 years
* Patients who have been admitted:
* Following cardiac or thoracic surgery or,
* For treatment of advanced heart failure
Exclusion Criteria:
* Pregnancy
* Diagnosed learning disability
* Pre-admission evidence of cognitive impairment
* Patients admitted to the ICU following ear nose and throat (ENT) procedures
* Patients admitted to the ICU following orthopaedics procedure
* Patients admitted to the ICU following general surgical procedures
* Patients admitted following out of hospital cardiac arrest
* Patients admitted for COVID-19 pneumonia
Arm 2
Inclusion Criteria:
For Patients:
* Length of stay within critical care \> 4 days
* Age \> 18 years
* Reason for admission
* Post-operative patients following cardiac or thoracic surgery or,
* Following admission for advanced heart failure therapies
* Provision of informed consent
For relatives:
* Age \> 18 years
* Relative of a patient that has been in critical care \> 4 days
* Relative of a patient who has been admitted:
* Following cardiac or thoracic surgery or,
* Treatment of advanced heart failure
* Relative of a patient admitted for \> 4days
For Staff:
* Age \> 18
* Clinical responsibility within the critical care department
Exclusion:
For patients:
* Prisoners
* Age \< 18yrs
* No family or social support
* Non-English speaker
* Pre-admission evidence of cognitive impairment
* Pre-admission diagnosis of learning disability
* Imminent death
* Brain injury
* Lacks capacity (using Montreal Cognitive Assessment tool (MoCA))
* Patients admitted after out of hospital cardiac arrest
* Patients admitted to the ICU following ENT procedures
* Patients admitted to the ICU following orthopaedics procedure
* Patients admitted to the ICU following general surgical procedures
* Patients admitted with COVID-19 pneumonia
For relatives:
* Prisoner
* Age \< 18yrs
* Non-English speaker
* Relative of a patient who is close to death
* Relative of a patient admitted after out of hospital cardiac arrest
* Relative of a patient admitted for ENT procedure
* Relative of a patient admitted for orthopaedic procedure
* Relative of a patient admitted following general surgical procedure
For Staff:
• Age \< 18yrs
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04538469
Study Brief:
Protocol Section:
NCT04538469