PIM-COVID: Psychological Impact of COVID-19 on Intensive Care Survivors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Anxiety [6 months post intensive care unit (ICU) discharge]
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
- Depression [6 months post ICU discharge]
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
- Symptoms of trauma [6 months post ICU discharge]
Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75.
Secondary Outcome Measures
- Anxiety [3 and/or 12 months post ICU discharge]
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
- Depression [3 and/or 12 months post ICU discharge]
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
- Symptoms of trauma [3 and/or 12 months post ICU discharge]
Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75.
- Metacognitive beliefs and processes [3, 6 and/or 12 months post ICU discharge]
Cognitive Attentional Syndrome Scale-1 (Revised; CAS-1R), which is a 10-item measure with responses scaled from 0%-100%, which are summed to produce a total score. Higher scores indicate greater conviction in metacognitive beliefs and greater use of maladaptive coping strategies to manage distress.
- Health-related quality of life [3, 6 and/or 12 months post ICU discharge]
EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L) comprises health status measures (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) divided into five levels of perceived problems and a visual analogue scale of health status ranging from 0-100.
- Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19 [Study duration, up to 1 year]
Response rate to invitations to participate/questionnaires.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients ≥18 years
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Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
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Treated for COVID-19
Exclusion Criteria:
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Unable to complete questionnaires
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Unable or unwilling to consent
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Unable to speak, understand or communicate in English
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Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU admission)
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Patients without a fixed abode, at which postal questionnaires might be received, and who have no access to a personal email address.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Cornwall Hospital | Truro | Cornwall | United Kingdom | TR1 3LJ |
| 2 | Barnsley Hospital | Barnsley | England | United Kingdom | S75 2EP |
| 3 | Basildon Hospital | Basildon | England | United Kingdom | SS16 5NL |
| 4 | Bedford Hospital | Bedford | England | United Kingdom | MK42 9DJ |
| 5 | Royal Blackburn Hospital | Blackburn | England | United Kingdom | BB2 3HH |
| 6 | Pilgrim Hospital | Boston | England | United Kingdom | PE21 9QS |
| 7 | Royal Papworth Hospital | Cambridge | England | United Kingdom | CB2 0AY |
| 8 | Cumberland Infirmary | Carlisle | England | United Kingdom | CA2 7HY |
| 9 | Chesterfield Royal Hospital | Chesterfield | England | United Kingdom | S44 5BL |
| 10 | Countess of Chester Hospital | Chester | England | United Kingdom | CH2 1UL |
| 11 | Colchester Hospital | Colchester | England | United Kingdom | CO4 5JL |
| 12 | Leighton Hospital | Crewe | England | United Kingdom | CW1 4QJ |
| 13 | Wonford Hospital | Exeter | England | United Kingdom | EX2 5DW |
| 14 | Queen Elizabeth Hospital | Gateshead | England | United Kingdom | NE9 6SX |
| 15 | Ipswich Hospital | Ipswich | England | United Kingdom | IP4 5PD |
| 16 | Kingston Hospital | Kingston Upon Thames | England | United Kingdom | KT2 7QB |
| 17 | Lincoln County Hospital | Lincoln | England | United Kingdom | LN2 5QY |
| 18 | Royal Liverpool University Hospital | Liverpool | England | United Kingdom | L7 8XP |
| 19 | Aintree University Hospital | Liverpool | England | United Kingdom | WD18 0HB |
| 20 | Lewisham and Greenwich Hospitals | London | England | United Kingdom | SE13 6LH |
| 21 | King's College Hospital NHS Foundation Trust | London | England | United Kingdom | SE5 9RS |
| 22 | Macclesfield District General Hospital | Macclesfield | England | United Kingdom | SK10 3BL |
| 23 | Maidstone Hospital | Maidstone | England | United Kingdom | ME16 9QQ |
| 24 | James Cook University Hospital | Middlesbrough | England | United Kingdom | TS4 3BW |
| 25 | Northumbria Healthcare NHS Foundation Trust | Newcastle Upon Tyne | England | United Kingdom | NE27 0QJ |
| 26 | Newcastle upon Tyne Hospitals Foundation Trust | Newcastle Upon Tyne | England | United Kingdom | NE7 7DN |
| 27 | Northampton General Hospital | Northampton | England | United Kingdom | NN1 5BD |
| 28 | Nottingham University Hospitals | Nottingham | England | United Kingdom | NG5 1PB |
| 29 | Royal Oldham Hospital | Oldham | England | United Kingdom | OL1 2JH |
| 30 | Derriford Hospital | Plymouth | England | United Kingdom | PL6 8DH |
| 31 | Whiston Hospital | Prescot | England | United Kingdom | L35 5DR |
| 32 | Rotherham General Hospital | Rotherham | England | United Kingdom | S60 2UD |
| 33 | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | England | United Kingdom | S10 2JF |
| 34 | Lister Hospital | Stevenage | England | United Kingdom | SG1 4AB |
| 35 | King's Mill Hospital | Sutton In Ashfield | England | United Kingdom | NG17 4JL |
| 36 | Musgrove Park Hospital | Taunton | England | United Kingdom | TA1 5DA |
| 37 | Tunbridge Wells Hospital | Tunbridge Wells | England | United Kingdom | TN2 4QJ |
| 38 | Pinderfields General Hospital | Wakefield | England | United Kingdom | WF1 4DG |
| 39 | Watford General Hospital | Watford | England | United Kingdom | WD18 0HB |
| 40 | Royal Albert Edward Infirmary | Wigan | England | United Kingdom | WN1 2NN |
| 41 | Ulster Hospital | Belfast | Northern Ireland | United Kingdom | BT16 1RH |
| 42 | Forth Valley Royal Hospital | Larbert | Scotland | United Kingdom | FK5 4WR |
| 43 | University Hospital of Wales | Cardiff | Wales | United Kingdom | CF14 4XW |
| 44 | Royal Glamorgan Hospital | Pontyclun | Wales | United Kingdom | CF72 8XR |
| 45 | Morriston Hospital | Swansea | Wales | United Kingdom | SA6 6NL |
Sponsors and Collaborators
- Royal Liverpool University Hospital
Investigators
- Principal Investigator: Alicia AC Waite, Royal Liverpool University Hospital
- Principal Investigator: Ingeborg D Welters, University of Liverpool
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- SP0316
- IRAS 282400
- NIHR CPMS 47545