Clinical trial NCT05246098: REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI
Official title: REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or Acute Respiratory Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Disease
COVID-19
Viral Infection
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Critical Care Trials Group
First posted: 2022-02-18
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who were admitted to ICU for \<24 hours

Primary outcomes:
measure: Clinical Frailty Score (Adults)
timeFrame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
measure: Functional Status Score (Pediatrics)
timeFrame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission
Secondary outcomes:
measure: Katz activities of daily living (ADL; adults)
timeFrame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
measure: EQ5D-5L (EuroQoL; Adults)
timeFrame: 6-months post ICU admission
measure: COVID-19 Yorkshire Rehab Screen
timeFrame: 6-months post ICU admission
measure: Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale
timeFrame: 6-months post PICU admission
measure: Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale
timeFrame: 6-months post PICU admission
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: St. Albert
country: Canada
facility: Sturgeon Community Hopsital
state: Alberta
city: New Westminister
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Children's Hospital of Winnipeg
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Izaak Walton Killam Hospital for Children
state: Nova Scotia
city: Brantford
country: Canada
facility: Brantford General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Intensive Care Unit
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Lévis
country: Canada
facility: Hôpital Hôtel-Dieu de Lévis
state: Quebec
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: The Centre hospitalier universitaire Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: Hôpital Fleurimont - Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Saskatchewan Health Authority
state: Saskatchewan
Study officials:
affiliation: McMaster University
name: Michelle E Kho, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: