REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI
- Conditions
- Respiratory DiseaseCOVID-19Viral Infection
- Registration Number
- NCT05246098
- Lead Sponsor
- McMaster University
- Brief Summary
Background: Many adults and some children with COVID-19 or acute respiratory infection become critically ill and need advanced life support in the Intensive Care Unit (ICU). Frailty is a medical condition of reduced function and health. Adults with frailty have a lower chance of surviving critical illness. The investigators are still learning about critically ill adults with COVID-19 or acute respiratory infection, and do not have much information on how frailty affects outcomes in critically ill children, with or without COVID-19 or acute respiratory infection. Rehabilitation can help survivors of COVID-19 or acute respiratory infection by improving strength and improve quality of life (QOL).
Objectives: The main goal of this research study is to see if patients with frailty have a lower chance of surviving COVID-19 or acute respiratory infection critical illness and more health problems after survival than patients without frailty. The investigators will also study the types of rehabilitation received by patients with COVID-19 or acute respiratory infection.
Methods: The investigators will include adults and children with COVID-19 or acute respiratory infection who are admitted to the ICUs that participate in the study. The investigators will gather data about each patient, including before and during their illness.
Outcomes: The investigators will collect level of frailty, function, and types of therapy, or rehabilitation received by patients. In adults, the investigators are most interested in learning if frailty influences mortality, or death. In children, the investigators are most interested in whether children with COVID-19 or acute respiratory infection critical illness are more likely to develop frailty. The investigators will also study post-hospital discharge location in survivors (e.g., home, rehabilitation).
Relevance: The COVID-19 pandemic is a global public health crisis. It is critical to understand how COVID-19 and other acute respiratory infection critical illness affects groups of people who are at higher risk, and the impact on outcomes that are important to patients, like functioning and QOL. The results will help policy makers plan post-hospital services for survivors, help healthcare workers understand the importance of rehabilitation practice for patients with COVID-19 or acute respiratory infection, and help researchers develop treatments to improve QOL after COVID-19 or acute respiratory infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- Adult and pediatric survivors of COVID-19 or acute respiratory infection admitted to participating intensive care units (ICUs) and PICUs. The investigators define children as less than, and adults as greater than or equal to, 18 years old, respectively. The investigators will include adults and pediatrics with a confirmed diagnosis of COVID-19, pediatric patients with MIS-C, and adults and pediatrics with suspected or proven acute respiratory infection with onset within 14 days of ICU/PICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high flow oxygen therapy.
- Patients who were admitted to ICU for <24 hours
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Status Score (Pediatrics) hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission Frailty (paediatrics)
Clinical Frailty Score (Adults) hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission Frailty
- Secondary Outcome Measures
Name Time Method COVID-19 Yorkshire Rehab Screen 6-months post ICU admission Physical function; cognition; quality of life; disease symptoms
EQ5D-5L (EuroQoL; Adults) 6-months post ICU admission Physical Functional
Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale 6-months post PICU admission Quality of Life; Each item is measured on a 5 point Likert scale with 0 indicating never and 4 indicating almost always.The Likert scores are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 3=25, and 4=0. A higher score indicates better health-related quality of life.
Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale 6-months post PICU admission Quality of Life; Each item is measured on a 5 point Likert scale with 0 indicating never and 4 indicating almost always.The Likert scores are reversed scored and linearly transform to a 0-100 scale with 0=100, 1-75, 2=50, 3=25, and 4=0. A higher score indicates better health-related quality of life.
Katz activities of daily living (ADL; adults) hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission Physical Functional
Trial Locations
- Locations (28)
Sturgeon Community Hopsital
π¨π¦St. Albert, Alberta, Canada
Royal Columbian Hospital
π¨π¦New Westminister, British Columbia, Canada
QEII Health Sciences Centre
π¨π¦Halifax, Nova Scotia, Canada
Izaak Walton Killam Hospital for Children
π¨π¦Halifax, Nova Scotia, Canada
The Centre hospitalier universitaire Sainte-Justine
π¨π¦MontrΓ©al, Quebec, Canada
Alberta Children's Hospital
π¨π¦Calgary, Alberta, Canada
University of Alberta
π¨π¦Edmonton, Alberta, Canada
Children's Hospital of Winnipeg
π¨π¦Winnipeg, Manitoba, Canada
Brantford General Hospital
π¨π¦Brantford, Ontario, Canada
Hamilton General Hospital
π¨π¦Hamilton, Ontario, Canada
St. Joseph's Healthcare Intensive Care Unit
π¨π¦Hamilton, Ontario, Canada
McMaster Children's Hospital
π¨π¦Hamilton, Ontario, Canada
Juravinski Hospital
π¨π¦Hamilton, Ontario, Canada
Kingston Health Sciences Centre
π¨π¦Kingston, Ontario, Canada
London Health Sciences Centre
π¨π¦London, Ontario, Canada
Children's Hospital of Eastern Ontario
π¨π¦Ottawa, Ontario, Canada
The Ottawa Hospital
π¨π¦Ottawa, Ontario, Canada
Niagara Health System
π¨π¦St. Catharines, Ontario, Canada
Sunnybrook Hospital
π¨π¦Toronto, Ontario, Canada
St. Michael's Hospital
π¨π¦Toronto, Ontario, Canada
The Hospital for Sick Children
π¨π¦Toronto, Ontario, Canada
HΓ΄pital HΓ΄tel-Dieu de LΓ©vis
π¨π¦LΓ©vis, Quebec, Canada
Montreal Children's Hospital
π¨π¦Montreal, Quebec, Canada
Centre hospitalier de l'UniversitΓ© de MontrΓ©al
π¨π¦MontrΓ©al, Quebec, Canada
HΓ΄pital du SacrΓ©-CΕur de MontrΓ©al
π¨π¦MontrΓ©al, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de QuΓ©bec
π¨π¦Quebec City, Quebec, Canada
HΓ΄pital Fleurimont - Sherbrooke
π¨π¦Sherbrooke, Quebec, Canada
Saskatchewan Health Authority
π¨π¦Regina, Saskatchewan, Canada