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

NCT05246098 | Recruiting

• 1 other identifier: REVIVe
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 28

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.

Conditions

Respiratory Disease; COVID-19; Viral Infection

Outcome Measures

Primary Outcomes (2)

• Clinical Frailty Score (Adults)

  Frailty

  hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission

• Functional Status Score (Pediatrics)

  Frailty (paediatrics)

  hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission

Secondary Outcomes (5)

• Katz activities of daily living (ADL; adults)

  hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission

• EQ5D-5L (EuroQoL; Adults)

  6-months post ICU admission

• COVID-19 Yorkshire Rehab Screen

  6-months post ICU admission

• Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale

  6-months post PICU admission

• Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale

  6-months post PICU admission

Study Arms (2)

Adults

Adult survivors of COVID-19 or acute respiratory infection admitted to participating ICUs. Adults are defined as greater than or equal to, 18 years old. We will include adults with a confirmed diagnosis of COVID-19 or those with suspected or proven acute respiratory infection with onset within 14 days of ICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high-flow oxygen therapy.

Pediatrics

Pediatric survivors of COVID-19, MIS-C, or acute respiratory infection admitted to participating pediatric intensive care units (PICUs). The investigators define children as less than 18 years old. We will include pediatric patients with COVID-19, those with multi-system inflammatory syndrome in children (MIS-C), and those with suspected or proven acute respiratory infection with onset within 14 days of ICU admission and requiring invasive mechanical ventilation, non-invasive ventilation, or high-flow oxygen therapy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Critical Care Trials Group: collaborator

Study Sites (28)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

ACTIVE NOT RECRUITING

University of Alberta

Edmonton, Alberta, T6G2B7, Canada

RECRUITING

Sturgeon Community Hopsital

St. Albert, Alberta, T8N 6C4, Canada

NOT YET RECRUITING

Royal Columbian Hospital

New Westminster, British Columbia, V3L 0A4, Canada

NOT YET RECRUITING

Children's Hospital of Winnipeg

Winnipeg, Manitoba, R3E 0Z3, Canada

ACTIVE NOT RECRUITING

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

Izaak Walton Killam Hospital for Children

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Brantford General Hospital

Brantford, Ontario, N3R 1G9, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

St. Joseph's Healthcare Intensive Care Unit

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

ACTIVE NOT RECRUITING

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

ACTIVE NOT RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

ACTIVE NOT RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Niagara Health System

St. Catharines, Ontario, L2S 0A9, Canada

RECRUITING

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

ACTIVE NOT RECRUITING

Hôpital Hôtel-Dieu de Lévis

Lévis, Quebec, G6V 3Z1, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

The Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

ACTIVE NOT RECRUITING

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Hôpital Fleurimont - Sherbrooke

Sherbrooke, Quebec, J1H 5H3, Canada

RECRUITING

Saskatchewan Health Authority

Regina, Saskatchewan, Canada

RECRUITING

MeSH Terms

Conditions

Respiration Disorders; COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Michelle E Kho, PT, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoff Strong, PT, MS

CONTACT

905-522-1155; revive@mcmaster.ca

Study Design

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

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 18, 2022
• Study Start: August 24, 2022
• Primary Completion: March 31, 2025
• Study Completion: October 1, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (28)