Clinical trial NCT05092529: Psychological Impact of COVID-19 on Intensive Care Survivors
Official title: The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Psychological Distress
Depression
Anxiety
Post-traumatic Stress Disorder
Post Intensive Care Syndrome
Lead sponsor: Royal Liverpool University Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-25
Enrollment: 1620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care survivors

Brief summary: Psychological distress is commonly experienced by survivors of an intensive care admission, including patients treated during previous pandemics. Whilst data emerges about the short-term impact of COVID-19 on patients and healthcare systems, the long term impact remains unclear.

The purpose of this trainee-led, multi-centre longitudinal study is to assess the short- and long-term psychological impact on patients who have survived an admission to intensive care due to COVID-19, and identify possible predictors of anxiety, depression and trauma symptoms in this patient group.

Detailed description: The primary objective is to identify the proportion of patients surviving an admission to intensive care due to COVID-19 who experience anxiety, depression and/or trauma symptoms in the 6 months post discharge.

Whilst the secondary objectives are to identify demographic, clinical, physical and/or psychosocial predictors of depression, anxiety and/or trauma symptoms at 3-, 6- and 12-months post discharge from ICU. And to assess the feasibility of using a self-reported online questionnaire to assess anxiety, depression and/or trauma symptoms in patients following ICU admission.

An amendment was approved by the East Midlands - Derby Research Ethics Committee on 17 March 2022, to conduct three sub-studies:

1. Semi-structured interviews - to explore the experiences of critical care survivors following COVID-19 infection during their recovery phase, including perceptions about the care received and support available to them.
2. Survey of follow-up services offered to ICU survivors - to assess geographical differences in the availability and structure of follow-up services offered to patients with critical COVID-19 after hospital discharge.
3. Survey of study team members - to gain feedback from the study team members on their involvement in the study.

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years
* Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
* Treated for COVID-19

Exclusion Criteria:

* Unable to complete questionnaires
* Unable or unwilling to consent
* Unable to speak, understand or communicate in English
* Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU admission)
* Patients without a fixed abode, at which postal questionnaires might be received, and who have no access to a personal email address.

Primary outcomes:
measure: Anxiety
timeFrame: 6 months post intensive care unit (ICU) discharge
measure: Depression
timeFrame: 6 months post ICU discharge
measure: Symptoms of trauma
timeFrame: 6 months post ICU discharge
Secondary outcomes:
measure: Anxiety
timeFrame: 3 and/or 12 months post ICU discharge
measure: Depression
timeFrame: 3 and/or 12 months post ICU discharge
measure: Symptoms of trauma
timeFrame: 3 and/or 12 months post ICU discharge
measure: Metacognitive beliefs and processes
timeFrame: 3, 6 and/or 12 months post ICU discharge
measure: Health-related quality of life
timeFrame: 3, 6 and/or 12 months post ICU discharge
measure: Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19
timeFrame: Study duration, up to 1 year
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital
state: England
city: Basildon
country: United Kingdom
facility: Basildon Hospital
state: England
city: Bedford
country: United Kingdom
facility: Bedford Hospital
state: England
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
state: England
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
state: England
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
state: England
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital
state: England
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
state: England
city: Colchester
country: United Kingdom
facility: Colchester Hospital
state: England
city: Crewe
country: United Kingdom
facility: Leighton Hospital
state: England
city: Exeter
country: United Kingdom
facility: Wonford Hospital
state: England
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: Kingston Upon Thames
country: United Kingdom
facility: Kingston Hospital
state: England
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
state: England
city: London
country: United Kingdom
facility: Lewisham and Greenwich Hospitals
state: England
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: England
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
state: England
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals Foundation Trust
state: England
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
state: England
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Prescot
country: United Kingdom
facility: Whiston Hospital
state: England
city: Rotherham
country: United Kingdom
facility: Rotherham General Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: England
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: England
city: Sutton In Ashfield
country: United Kingdom
facility: King's Mill Hospital
state: England
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
state: England
city: Tunbridge Wells
country: United Kingdom
facility: Tunbridge Wells Hospital
state: England
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
state: England
city: Watford
country: United Kingdom
facility: Watford General Hospital
state: England
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
state: England
city: Belfast
country: United Kingdom
facility: Ulster Hospital
state: Northern Ireland
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital
state: Scotland
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
city: Pontyclun
country: United Kingdom
facility: Royal Glamorgan Hospital
state: Wales
city: Swansea
country: United Kingdom
facility: Morriston Hospital
state: Wales
city: London
country: United Kingdom
facility: North Middlesex University Hospital
city: London
country: United Kingdom
facility: Southend University Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Romford
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
Study officials:
affiliation: Royal Liverpool University Hospital
name: Alicia AC Waite
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liverpool
name: Ingeborg D Welters
role: PRINCIPAL_INVESTIGATOR
References: