COVID19-OR (SARS-CoV-2): Observation,Risk & Recovery

Study Overview
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Brief Summary
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A novel coronavirus, designated corona virus disease 2019 (COVID-19) has resulted in a Pandemic at the time of writing (27th April) the reported number of confirmed cases exceeding 3 million and over 200000 associated deaths. The burden on global critical care has been considerable. As of 24th April there have been 8752 UK critical care admissions with services under considerable strain, and a mortality rate over 50%. Survivors of critical illness will require significant input. This study will perform mixed methods to provide rich data on risk stratification and recovery from critical illness. Recovery from a novel disease requires documenting and the study reports physical and psychological changes following hospital discharge in survivors. In addition qualitative interviews are being conducted with patients who have survived and been discharged from critical care along with their relatives and treating professionals, to better understand their needs during recovery.

Official Title
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COVID19-OR (SARS-CoV-2):Observation, Risk & Recovery. An Observational Study Exploring Risk Assessment and Recovery From COVID-19 (SARS-CoV-2) Infection in Hospitalised Patients

Conditions
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Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years admitted to ICU with SARS-CoV-2 and survived Relatives or friends and professionals involved in the care of these patients. Exclusion Criteria: Patients <18 years; Patients with a negative test for SARS-CoV-2 or patients not tested due to absence of symptoms;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical | Chelsea critical care physical assessment tool | through study completion , an average of 1 year | 
| Physical | Incremental Shuttle Walk Test (ISWT) | through study completion , an average of 1 year | 
| Physical | 1- minute Sit to Stand, Grip strength | through study completion , an average of 1 year | 
| Health Related Quality of life | Short Form Survey on health related quality of life (SF-12). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. Higher scores indicate better outcome. | at 3 months | 
| Health Related Quality of life | Short Form Survey on health related quality of life (SF-36). Scores can range from 0 to 100 and a higher score indicates better outcome. | at 1 year | 
| Psychological | Depression Test Questionnaire (PHQ-9). Scores range from 1 to 27 and higher scores indicate worse outcome. | through study completion , an average of 1 year | 
| Psychological | Anxiety Test Questionnaire (GAD-7). Scores range from 0 to 21 and higher scores indicates worse outcome. | through study completion , an average of 1 year | 
| Psychological | Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30 and higher scores indicate a better outcome. | through study completion , an average of 1 year | 
| Psychological | Post-traumatic stress disorder (PTSD) Trauma Screening (TSQ). A screening tool with 10 items. If 6 items are endorsed then the outcome is 'positive' for PTSD. | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk stratification | escalation to critical care (Yes/No) | through study completion and average of 1 year | 
| risk stratification | mechanical ventilation (Yes/No) | through study completion and average of 1 year | 
| risk stratification | critical care stay hospital stay (number of days) | through study completion and average of 1 year |