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Clinical Trials/NCT04524520
NCT04524520
Completed
Not Applicable

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

Western Sussex Hospitals NHS Trust1 site in 1 country194 target enrollmentMay 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exploring Risk Assessment and Recovery From COVID-19 Infection in Hospitalised Patients
Sponsor
Western Sussex Hospitals NHS Trust
Enrollment
194
Locations
1
Primary Endpoint
Health Related Quality of life
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2020
End Date
June 8, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Western Sussex Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Health Related Quality of life

Time Frame: at 1 year

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.

Psychological

Time Frame: at 1 year

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.

Physical

Time Frame: through study completion , an average of 1 year

1- minute Sit to Stand, Grip strength

Secondary Outcomes

  • risk stratification(through study completion and average of 1 year)

Study Sites (1)

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