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

November 4, 2024 updated by: McMaster University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Active, not recruiting
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G2B7
        • Recruiting
        • University of Alberta
        • Contact:
      • St. Albert, Alberta, Canada, T8N 6C4
        • Not yet recruiting
        • Sturgeon Community Hopsital
        • Contact:
    • British Columbia
      • New Westminister, British Columbia, Canada, V3L 0A4
        • Not yet recruiting
        • Royal Columbian Hospital
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0Z3
        • Active, not recruiting
        • Children's Hospital of Winnipeg
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
      • Halifax, Nova Scotia, Canada, B3K 6R8
    • Ontario
      • Brantford, Ontario, Canada, N3R 1G9
      • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton, Ontario, Canada, L8V 1C3
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare Intensive Care Unit
        • Contact:
      • Hamilton, Ontario, Canada, L8S 4K1
        • Active, not recruiting
        • McMaster Children's Hospital
      • Kingston, Ontario, Canada, K7L 2V7
      • London, Ontario, Canada, N6A 5W9
        • Active, not recruiting
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L1
        • Active, not recruiting
        • Children's Hospital of Eastern Ontario
      • St. Catharines, Ontario, Canada, L2S 0A9
      • Toronto, Ontario, Canada, M5B 1W8
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 1E8
        • Active, not recruiting
        • The Hospital for Sick Children
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
      • Montreal, Quebec, Canada, H4A 3J1
        • Active, not recruiting
        • Montreal Children's Hospital
      • Montréal, Quebec, Canada, H4J 1C5
      • Montréal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de L'Universite de Montreal
        • Contact:
      • Montréal, Quebec, Canada, H3T 1C5
      • Quebec City, Quebec, Canada, G1V 4G5
      • Sherbrooke, Quebec, Canada, J1H 5H3
    • Saskatchewan
      • Regina, Saskatchewan, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Frailty Score (Adults)
Time Frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Frailty
hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Functional Status Score (Pediatrics)
Time Frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission
Frailty (paediatrics)
hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Katz activities of daily living (ADL; adults)
Time Frame: hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
Physical Functional
hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admission
EQ5D-5L (EuroQoL; Adults)
Time Frame: 6-months post ICU admission
Physical Functional
6-months post ICU admission
COVID-19 Yorkshire Rehab Screen
Time Frame: 6-months post ICU admission
Physical function; cognition; quality of life; disease symptoms
6-months post ICU admission
Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale
Time Frame: 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.
6-months post PICU admission
Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale
Time Frame: 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.
6-months post PICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group

Investigators

  • Principal Investigator: Michelle E Kho, PT, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REVIVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe