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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS 282400 | Registry Identifier | IRAS | |
| NIHR CPMS 47545 | Registry Identifier | NIHR CPMS |
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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.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case). | 6 months post intensive care unit (ICU) discharge |
| Depression | Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case). | 6 months post ICU discharge |
| Symptoms of trauma | Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75. | 6 months post ICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case). | 3 and/or 12 months post ICU discharge |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
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Intensive care survivors
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| Name | Affiliation | Role |
|---|---|---|
| Alicia AC Waite | Royal Liverpool University Hospital | Principal Investigator |
| Ingeborg D Welters | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom | ||
| Barnsley Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37758678 | Derived | 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. |
| Label | URL |
|---|---|
| Trainee Research in Intensive Care Network website | View source |
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Upon the conclusion of the study, the dataset may be made available from the corresponding author on reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 19, 2023 |
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Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
| 3 and/or 12 months post ICU discharge |
| Symptoms of trauma | Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75. | 3 and/or 12 months post ICU discharge |
| Metacognitive beliefs and processes | 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. | 3, 6 and/or 12 months post ICU discharge |
| Health-related quality of life | 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. | 3, 6 and/or 12 months post ICU discharge |
| Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19 | Response rate to invitations to participate/questionnaires. | Study duration, up to 1 year |
| Barnsley |
| England |
| S75 2EP |
| United Kingdom |
| Basildon Hospital | Basildon | England | SS16 5NL | United Kingdom |
| Bedford Hospital | Bedford | England | MK42 9DJ | United Kingdom |
| Royal Blackburn Hospital | Blackburn | England | BB2 3HH | United Kingdom |
| Pilgrim Hospital | Boston | England | PE21 9QS | United Kingdom |
| Royal Papworth Hospital | Cambridge | England | CB2 0AY | United Kingdom |
| Cumberland Infirmary | Carlisle | England | CA2 7HY | United Kingdom |
| Countess of Chester Hospital | Chester | England | CH2 1UL | United Kingdom |
| Chesterfield Royal Hospital | Chesterfield | England | S44 5BL | United Kingdom |
| Colchester Hospital | Colchester | England | CO4 5JL | United Kingdom |
| Leighton Hospital | Crewe | England | CW1 4QJ | United Kingdom |
| Wonford Hospital | Exeter | England | EX2 5DW | United Kingdom |
| Queen Elizabeth Hospital | Gateshead | England | NE9 6SX | United Kingdom |
| Ipswich Hospital | Ipswich | England | IP4 5PD | United Kingdom |
| Kingston Hospital | Kingston upon Thames | England | KT2 7QB | United Kingdom |
| Lincoln County Hospital | Lincoln | England | LN2 5QY | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | England | L7 8XP | United Kingdom |
| Aintree University Hospital | Liverpool | England | WD18 0HB | United Kingdom |
| Lewisham and Greenwich Hospitals | London | England | SE13 6LH | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | England | SE5 9RS | United Kingdom |
| Macclesfield District General Hospital | Macclesfield | England | SK10 3BL | United Kingdom |
| Maidstone Hospital | Maidstone | England | ME16 9QQ | United Kingdom |
| James Cook University Hospital | Middlesbrough | England | TS4 3BW | United Kingdom |
| Northumbria Healthcare NHS Foundation Trust | Newcastle upon Tyne | England | NE27 0QJ | United Kingdom |
| Newcastle upon Tyne Hospitals Foundation Trust | Newcastle upon Tyne | England | NE7 7DN | United Kingdom |
| Northampton General Hospital | Northampton | England | NN1 5BD | United Kingdom |
| Nottingham University Hospitals | Nottingham | England | NG5 1PB | United Kingdom |
| Royal Oldham Hospital | Oldham | England | OL1 2JH | United Kingdom |
| Derriford Hospital | Plymouth | England | PL6 8DH | United Kingdom |
| Whiston Hospital | Prescot | England | L35 5DR | United Kingdom |
| Rotherham General Hospital | Rotherham | England | S60 2UD | United Kingdom |
| Tunbridge Wells Hospital | Royal Tunbridge Wells | England | TN2 4QJ | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | England | S10 2JF | United Kingdom |
| Lister Hospital | Stevenage | England | SG1 4AB | United Kingdom |
| King's Mill Hospital | Sutton in Ashfield | England | NG17 4JL | United Kingdom |
| Musgrove Park Hospital | Taunton | England | TA1 5DA | United Kingdom |
| Pinderfields General Hospital | Wakefield | England | WF1 4DG | United Kingdom |
| Watford General Hospital | Watford | England | WD18 0HB | United Kingdom |
| Royal Albert Edward Infirmary | Wigan | England | WN1 2NN | United Kingdom |
| Ulster Hospital | Belfast | Northern Ireland | BT16 1RH | United Kingdom |
| Forth Valley Royal Hospital | Larbert | Scotland | FK5 4WR | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| Royal Glamorgan Hospital | Pont-y-clun | Wales | CF72 8XR | United Kingdom |
| Morriston Hospital | Swansea | Wales | SA6 6NL | United Kingdom |
| North Middlesex University Hospital | London | N18 1QX | United Kingdom |
| Southend University Hospital | London | SS2 6XT | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| North Manchester General Hospital | Manchester | M8 5RB | United Kingdom |
| Barking, Havering and Redbridge University Hospitals NHS Trust | Romford | RM7 0AG | United Kingdom |
| Nov 21, 2023 |
| Prot_SAP_ICF_002.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| C000657744 | postintensive care syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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