REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI

COVID-19 Clinical Trial

— REVIVe  

Official title:

REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or Acute Respiratory Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246098
• Other study ID #: REVIVe
• Status: Recruiting
• Start date: September 15, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2024
• Source: McMaster University
• Contact: Geoff Strong, PT, MS
• Phone: 905-522-1155
• Email: revive[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 1, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Frailty
• Infections
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Viral Infection
• Virus Diseases

Locations

Country	Name	City	State
Canada	Brantford General Hospital	Brantford	Ontario
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Intensive Care Unit	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Hôpital Hôtel-Dieu de Lévis	Lévis	Quebec
Canada	London Health Sciences Centre	London	Ontario
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Hôpital du Sacré-Cœur de Montréal	Montréal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec City	Quebec
Canada	Saskatchewan Health Authority	Regina	Saskatchewan
Canada	Hôpital Fleurimont - Sherbrooke	Sherbrooke	Quebec
Canada	Niagara Health System	St. Catharines	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital Research Institute	Vancouver	British Columbia
Canada	Children's Hospital of Winnipeg	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Frailty Score (Adults)	Frailty	hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Primary	Functional Status Score (Pediatrics)	Frailty (paediatrics)	hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission
Secondary	Katz activities of daily living (ADL; adults)	Physical Functional	hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Secondary	EQ5D-5L (EuroQoL; Adults)	Physical Functional	6-months post ICU admission
Secondary	COVID-19 Yorkshire Rehab Screen	Physical function; cognition; quality of life; disease symptoms	6-months post ICU admission
Secondary	Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale	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.	6-months post PICU admission
Secondary	Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale	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.	6-months post PICU admission