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NCT05092529 Clinical Trial

Psychological Impact of COVID-19 on Intensive Care Survivors

Depression Clinical Trial

— PIM-COVID  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05092529
Other study ID # SP0316
Secondary ID IRAS 282400NIHR
Status Completed
Phase
First received
Last updated
Start date November 17, 2020
Est. completion date November 17, 2023

Study information
Verified date November 2023
Source Royal Liverpool University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1620
Est. completion date November 17, 2023
Est. primary completion date February 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Barnsley Hospital Barnsley England
United Kingdom Basildon Hospital Basildon England
United Kingdom Bedford Hospital Bedford England
United Kingdom Ulster Hospital Belfast Northern Ireland
United Kingdom Royal Blackburn Hospital Blackburn England
United Kingdom Pilgrim Hospital Boston England
United Kingdom Royal Papworth Hospital Cambridge England
United Kingdom University Hospital of Wales Cardiff Wales
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 Forth Valley Royal Hospital Larbert Scotland
United Kingdom Lincoln County Hospital Lincoln England
United Kingdom Aintree University Hospital Liverpool England
United Kingdom Royal Liverpool University Hospital Liverpool England
United Kingdom King's College Hospital NHS Foundation Trust London England
United Kingdom Lewisham and Greenwich Hospitals London England
United Kingdom North Middlesex University Hospital London
United Kingdom Southend University Hospital London
United Kingdom Macclesfield District General Hospital Macclesfield England
United Kingdom Maidstone Hospital Maidstone England
United Kingdom Manchester Royal Infirmary Manchester
United Kingdom North Manchester General Hospital Manchester
United Kingdom James Cook University Hospital Middlesbrough England
United Kingdom Newcastle upon Tyne Hospitals Foundation Trust Newcastle Upon Tyne England
United Kingdom Northumbria Healthcare NHS 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 Royal Glamorgan Hospital Pontyclun Wales
United Kingdom Whiston Hospital Prescot England
United Kingdom Barking, Havering and Redbridge University Hospitals NHS Trust Romford
United Kingdom Rotherham General Hospital Rotherham 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 Morriston Hospital Swansea Wales
United Kingdom Musgrove Park Hospital Taunton England
United Kingdom Royal Cornwall Hospital Truro Cornwall
United Kingdom Tunbridge Wells Hospital Tunbridge Wells England
United Kingdom Pinderfields General Hospital Wakefield England
United Kingdom Watford General Hospital Watford England
United Kingdom Royal Albert Edward Infirmary Wigan England

Sponsors (1)
Lead Sponsor Collaborator
Royal Liverpool University Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary Depression 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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