NCT05092529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

50 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

October 18, 2021

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (6)

  • Anxiety

    3 and/or 12 months post ICU discharge

  • Depression

    3 and/or 12 months post ICU discharge

  • Symptoms of trauma

    3 and/or 12 months post ICU discharge

  • Metacognitive beliefs and processes

    3, 6 and/or 12 months post ICU discharge

  • Health-related quality of life

    3, 6 and/or 12 months post ICU discharge

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care survivors

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (50)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Barnsley Hospital

Barnsley, England, S75 2EP, United Kingdom

Location

Basildon Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Bedford Hospital

Bedford, England, MK42 9DJ, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, England, BB2 3HH, United Kingdom

Location

Pilgrim Hospital

Boston, England, PE21 9QS, United Kingdom

Location

Royal Papworth Hospital

Cambridge, England, CB2 0AY, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Countess of Chester Hospital

Chester, England, CH2 1UL, United Kingdom

Location

Chesterfield Royal Hospital

Chesterfield, England, S44 5BL, United Kingdom

Location

Colchester Hospital

Colchester, England, CO4 5JL, United Kingdom

Location

Leighton Hospital

Crewe, England, CW1 4QJ, United Kingdom

Location

Wonford Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Kingston Hospital

Kingston upon Thames, England, KT2 7QB, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Aintree University Hospital

Liverpool, England, WD18 0HB, United Kingdom

Location

Lewisham and Greenwich Hospitals

London, England, SE13 6LH, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, England, SE5 9RS, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, England, SK10 3BL, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Newcastle upon Tyne, England, NE27 0QJ, United Kingdom

Location

Newcastle upon Tyne Hospitals Foundation Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Nottingham University Hospitals

Nottingham, England, NG5 1PB, United Kingdom

Location

Royal Oldham Hospital

Oldham, England, OL1 2JH, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Whiston Hospital

Prescot, England, L35 5DR, United Kingdom

Location

Rotherham General Hospital

Rotherham, England, S60 2UD, United Kingdom

Location

Tunbridge Wells Hospital

Royal Tunbridge Wells, England, TN2 4QJ, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, England, S10 2JF, United Kingdom

Location

Lister Hospital

Stevenage, England, SG1 4AB, United Kingdom

Location

King's Mill Hospital

Sutton in Ashfield, England, NG17 4JL, United Kingdom

Location

Musgrove Park Hospital

Taunton, England, TA1 5DA, United Kingdom

Location

Pinderfields General Hospital

Wakefield, England, WF1 4DG, United Kingdom

Location

Watford General Hospital

Watford, England, WD18 0HB, United Kingdom

Location

Royal Albert Edward Infirmary

Wigan, England, WN1 2NN, United Kingdom

Location

Ulster Hospital

Belfast, Northern Ireland, BT16 1RH, United Kingdom

Location

Forth Valley Royal Hospital

Larbert, Scotland, FK5 4WR, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Royal Glamorgan Hospital

Pont-y-clun, Wales, CF72 8XR, United Kingdom

Location

Morriston Hospital

Swansea, Wales, SA6 6NL, United Kingdom

Location

North Middlesex University Hospital

London, N18 1QX, United Kingdom

Location

Southend University Hospital

London, SS2 6XT, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

North Manchester General Hospital

Manchester, M8 5RB, United Kingdom

Location

Barking, Havering and Redbridge University Hospitals NHS Trust

Romford, RM7 0AG, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

COVID-19DepressionAnxiety DisordersStress Disorders, Post-Traumaticpostintensive care syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Alicia AC Waite

    Royal Liverpool University Hospital

    PRINCIPAL INVESTIGATOR
  • Ingeborg D Welters

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Clinical Research Fellow

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 25, 2021

Study Start

November 17, 2020

Primary Completion

February 14, 2023

Study Completion

November 17, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations