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REVIVe: Frailty, Rehabilitation, and Hospitalization Outcomes in Adult and Pediatric Survivors of COVID-19 (REVIVe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05246098
Recruitment Status : Recruiting
First Posted : February 18, 2022
Last Update Posted : February 8, 2023
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Information provided by (Responsible Party):
McMaster University

Study Description
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Brief Summary:

Background: Many adults and some children with COVID-19 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, and do not have much information on how frailty affects outcomes in critically ill children, with or without COVID-19. Rehabilitation can help survivors of COVID-19 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 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.

Methods: The investigators will include adults and children with COVID-19 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 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 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, and researchers develop treatments to improve QOL after COVID-19.


Condition or disease
Respiratory Disease COVID-19 Viral Infection

Study Design
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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: REVIVe: Frailty, Rehabilitation, and Hospitalization Outcomes in Adult and Pediatric Survivors of COVID-19
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Adults
Adult survivors of severe acute respiratory syndrome (SARS) SARS-CoV-2 disease admitted to participating ICUs. Adults are defined as adults as greater than or equal to, 18 years old. We will include adults with a confirmed diagnosis of COVID-19.
Pediatrics
Pediatric survivors of severe SARS-CoV-2 disease 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 and those with multi-system inflammatory syndrome in children (MIS-C).


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Frailty Score (Adults) [ Time Frame: hospital discharge, 6-month hospital discharge ]
    Frailty

  2. Functional Status Score (Pediatrics) [ Time Frame: PICU discharge; 6-months post-PICU discharge ]
    Frailty (paediatrics)


Secondary Outcome Measures :
  1. Katz activities of daily living (ADL; adults) [ Time Frame: hospital discharge, approximately 28 days after enrolment ]
    Physical Functional

  2. EQ5D-5L (EuroQoL; Adults) [ Time Frame: hospital discharge, approximately 28 days after enrolment; 6-month hospital discharge ]
    Physical Functional

  3. COVID-19 Yorkshire Rehab Screen [ Time Frame: 6-months post-hospital discharge ]
    Physical function; cognition; quality of life; disease symptoms

  4. Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale [ Time Frame: 6-months post-PICU discharge ]
    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.

  5. Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale [ Time Frame: 6-months post-PICU discharge ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric survivors of severe SARS-CoV-2 disease admitted to participating 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 with a confirmed diagnosis of COVID-19. The investigators will include pediatric patients with COVID-19 and those with MIS-C.
Criteria

Inclusion Criteria:

  • Adult and pediatric survivors of severe SARS-CoV-2 disease 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 with a confirmed diagnosis of COVID-19. The investigators will include pediatric patients with COVID-19 and those with MIS-C.

Exclusion Criteria:

  • The investigators will exclude patients who were admitted to ICU for <24 hours or did not receive at least one of the following therapeutic life support interventions: mechanical ventilation (e.g., invasive, non-invasive, high flow nasal cannula), vasoactive medications (vasopressors or inotropes), or acute renal replacement therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05246098


Contacts
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Contact: Geoff Strong, PT, MS 905-522-1155 ext 33242 strong@mcmaster.ca

Locations
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Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Oleksa Rewa, MD, MSc    780.231.3280    rewa@ualberta.ca   
Canada, Ontario
St. Joseph's Healthcare Intensive Care Unit Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Michelle Kho, PT, PhD       khome@mcmaster.ca   
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Karen Choong, MB, FRCP(C), MSc       choongk@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Investigators
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Principal Investigator: Michelle E Kho, PT, PhD McMaster University
More Information
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT05246098    
Other Study ID Numbers: in-progress
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Respiration Disorders
Respiratory Tract Diseases
Frailty
Respiratory Tract Infections
Infections
Pneumonia, Viral
 Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Pathologic Processes