Psychological Impact of COVID-19 on Intensive Care Survivors (PIM-COVID)

November 21, 2023 updated by: Alicia Waite, Royal Liverpool University Hospital

The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1620

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, N18 1QX
        • North Middlesex University Hospital
      • London, United Kingdom, SS2 6XT
        • Southend University Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Manchester, United Kingdom, M8 5RB
        • North Manchester General Hospital
      • Romford, United Kingdom, RM7 0AG
        • Barking, Havering and Redbridge University Hospitals NHS Trust
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
    • England
      • Barnsley, England, United Kingdom, S75 2EP
        • Barnsley Hospital
      • Basildon, England, United Kingdom, SS16 5NL
        • Basildon Hospital
      • Bedford, England, United Kingdom, MK42 9DJ
        • Bedford Hospital
      • Blackburn, England, United Kingdom, BB2 3HH
        • Royal Blackburn Hospital
      • Boston, England, United Kingdom, PE21 9QS
        • Pilgrim Hospital
      • Cambridge, England, United Kingdom, CB2 0AY
        • Royal Papworth Hospital
      • Carlisle, England, United Kingdom, CA2 7HY
        • Cumberland Infirmary
      • Chester, England, United Kingdom, CH2 1UL
        • Countess of Chester Hospital
      • Chesterfield, England, United Kingdom, S44 5BL
        • Chesterfield Royal Hospital
      • Colchester, England, United Kingdom, CO4 5JL
        • Colchester Hospital
      • Crewe, England, United Kingdom, CW1 4QJ
        • Leighton Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Wonford Hospital
      • Gateshead, England, United Kingdom, NE9 6SX
        • Queen Elizabeth Hospital
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Kingston Upon Thames, England, United Kingdom, KT2 7QB
        • Kingston Hospital
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, England, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • Liverpool, England, United Kingdom, WD18 0HB
        • Aintree University Hospital
      • London, England, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, England, United Kingdom, SE13 6LH
        • Lewisham and Greenwich Hospitals
      • Macclesfield, England, United Kingdom, SK10 3BL
        • Macclesfield District General Hospital
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Maidstone Hospital
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle Upon Tyne, England, United Kingdom, NE27 0QJ
        • Northumbria Healthcare NHS Foundation Trust
      • Newcastle Upon Tyne, England, United Kingdom, NE7 7DN
        • Newcastle upon Tyne Hospitals Foundation Trust
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham University Hospitals
      • Oldham, England, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Prescot, England, United Kingdom, L35 5DR
        • Whiston Hospital
      • Rotherham, England, United Kingdom, S60 2UD
        • Rotherham General Hospital
      • Sheffield, England, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust
      • Stevenage, England, United Kingdom, SG1 4AB
        • Lister Hospital
      • Sutton In Ashfield, England, United Kingdom, NG17 4JL
        • King's Mill Hospital
      • Taunton, England, United Kingdom, TA1 5DA
        • Musgrove Park Hospital
      • Tunbridge Wells, England, United Kingdom, TN2 4QJ
        • Tunbridge Wells Hospital
      • Wakefield, England, United Kingdom, WF1 4DG
        • Pinderfields General Hospital
      • Watford, England, United Kingdom, WD18 0HB
        • Watford General Hospital
      • Wigan, England, United Kingdom, WN1 2NN
        • Royal Albert Edward Infirmary
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT16 1RH
        • Ulster Hospital
    • Scotland
      • Larbert, Scotland, United Kingdom, FK5 4WR
        • Forth Valley Royal Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Pontyclun, Wales, United Kingdom, CF72 8XR
        • Royal Glamorgan Hospital
      • Swansea, Wales, United Kingdom, SA6 6NL
        • Morriston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Intensive care survivors

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 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).
6 months post intensive care unit (ICU) discharge
Depression
Time Frame: 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).
6 months post ICU discharge
Symptoms of trauma
Time Frame: 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.
6 months post ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 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).
3 and/or 12 months post ICU discharge
Depression
Time Frame: 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).
3 and/or 12 months post ICU discharge
Symptoms of trauma
Time Frame: 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.
3 and/or 12 months post ICU discharge
Metacognitive beliefs and processes
Time Frame: 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.
3, 6 and/or 12 months post ICU discharge
Health-related quality of life
Time Frame: 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.
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
Time Frame: Study duration, up to 1 year
Response rate to invitations to participate/questionnaires.
Study duration, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Liverpool University Hospital

Investigators

  • Principal Investigator: Ingeborg D Welters, University of Liverpool
  • Principal Investigator: Alicia AC Waite, Royal Liverpool University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0316
  • IRAS 282400 (Registry Identifier: IRAS)
  • NIHR CPMS 47545 (Registry Identifier: NIHR CPMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon the conclusion of the study, the dataset may be made available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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