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Clinical Trials/NCT05092529
NCT05092529
Completed
Not Applicable

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

Royal Liverpool University Hospital50 sites in 1 country1,620 target enrollmentNovember 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Royal Liverpool University Hospital
Enrollment
1620
Locations
50
Primary Endpoint
Depression
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 17, 2020
End Date
November 17, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alicia Waite

Postdoctoral Clinical Research Fellow

Royal Liverpool University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

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.

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).

Secondary Outcomes

  • Depression(3 and/or 12 months post ICU discharge)
  • Metacognitive beliefs and processes(3, 6 and/or 12 months post ICU discharge)
  • Anxiety(3 and/or 12 months post ICU discharge)
  • Symptoms of trauma(3 and/or 12 months post ICU discharge)
  • Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19(Study duration, up to 1 year)
  • Health-related quality of life(3, 6 and/or 12 months post ICU discharge)

Study Sites (50)

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