Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection
NCT04385121
Anxiety, Anxiety Disorders
Strasbourg, France
View Trial DetailsNCT Number: NCT05092529
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.
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Notify Me18 year and older
All sexes
Observational
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
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.
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).
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).
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.
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.
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.
Time frame: Study duration, up to 1 year
Response rate to invitations to participate/questionnaires.
Royal Liverpool University Hospital
Other Gov
The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom
Acronym: PIM-COVID
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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