Psychological Impact of COVID-19 on Intensive Care Survivors
NCT ID: NCT05092529
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1620 participants
OBSERVATIONAL
2020-11-17
2023-11-17
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
* Treated for COVID-19
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Royal Liverpool University Hospital
OTHER_GOV
Responsible Party
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Alicia Waite
Postdoctoral Clinical Research Fellow
Principal Investigators
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Alicia AC Waite
Role: PRINCIPAL_INVESTIGATOR
Royal Liverpool University Hospital
Ingeborg D Welters
Role: PRINCIPAL_INVESTIGATOR
University of Liverpool
Locations
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Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Barnsley Hospital
Barnsley, England, United Kingdom
Basildon Hospital
Basildon, England, United Kingdom
Bedford Hospital
Bedford, England, United Kingdom
Royal Blackburn Hospital
Blackburn, England, United Kingdom
Pilgrim Hospital
Boston, England, United Kingdom
Royal Papworth Hospital
Cambridge, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Countess of Chester Hospital
Chester, England, United Kingdom
Chesterfield Royal Hospital
Chesterfield, England, United Kingdom
Colchester Hospital
Colchester, England, United Kingdom
Leighton Hospital
Crewe, England, United Kingdom
Wonford Hospital
Exeter, England, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Kingston Hospital
Kingston upon Thames, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Lewisham and Greenwich Hospitals
London, England, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Macclesfield District General Hospital
Macclesfield, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Newcastle upon Tyne, England, United Kingdom
Newcastle upon Tyne Hospitals Foundation Trust
Newcastle upon Tyne, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Nottingham University Hospitals
Nottingham, England, United Kingdom
Royal Oldham Hospital
Oldham, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Whiston Hospital
Prescot, England, United Kingdom
Rotherham General Hospital
Rotherham, England, United Kingdom
Tunbridge Wells Hospital
Royal Tunbridge Wells, England, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, England, United Kingdom
Lister Hospital
Stevenage, England, United Kingdom
King's Mill Hospital
Sutton in Ashfield, England, United Kingdom
Musgrove Park Hospital
Taunton, England, United Kingdom
Pinderfields General Hospital
Wakefield, England, United Kingdom
Watford General Hospital
Watford, England, United Kingdom
Royal Albert Edward Infirmary
Wigan, England, United Kingdom
Ulster Hospital
Belfast, Northern Ireland, United Kingdom
Forth Valley Royal Hospital
Larbert, Scotland, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Royal Glamorgan Hospital
Pont-y-clun, Wales, United Kingdom
Morriston Hospital
Swansea, Wales, United Kingdom
North Middlesex University Hospital
London, , United Kingdom
Southend University Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, , United Kingdom
Countries
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References
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Waite AAC, Johnston BW, Boyle AJ, Cherry MG, Fisher P, Brown SL, Jones C, Williams K, Welters ID. PIM-COVID study: protocol for a multicentre, longitudinal study measuring the psychological impact of surviving an intensive care admission due to COVID-19 on patients in the UK. BMJ Open. 2023 Sep 27;13(9):e071730. doi: 10.1136/bmjopen-2023-071730.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Trainee Research in Intensive Care Network website
Other Identifiers
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IRAS 282400
Identifier Type: REGISTRY
Identifier Source: secondary_id
NIHR CPMS 47545
Identifier Type: REGISTRY
Identifier Source: secondary_id
SP0316
Identifier Type: -
Identifier Source: org_study_id