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

NCT04524520 | Completed

• 1 other identifier: 20/YH/0157
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• risk stratification

  through study completion and average of 1 year

• risk stratification

  through study completion and average of 1 year

• risk stratification

  through study completion and average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to hospital with suspected/confirmed COVID-19.

You may qualify if:

• Adults ≥18 years admitted to ICU with SARS-CoV-2 and survived
• Relatives or friends and professionals involved in the care of these patients.

You may not qualify if:

• Patients \<18 years;
• Patients with a negative test for SARS-CoV-2 or patients not tested due to absence of symptoms;

Sponsors & Collaborators

• Western Sussex Hospitals NHS Trust: lead

Study Sites (1)

Dr Luke Hodgson

Worthing, United Kingdom

Location

Study Officials

• Dr Luke Hodgson

  Western Sussex Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: May 5, 2020
• Primary Completion: May 8, 2022
• Study Completion: June 8, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

GB (1)