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NCT Number: NCT05246098

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical Frailty Score (Adults)

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

    Frailty

  2. Functional Status Score (Pediatrics)

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

    Frailty (paediatrics)

Secondary outcomes

  1. 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

  2. EQ5D-5L (EuroQoL; Adults)

    Time frame: 6-months post ICU admission

    Physical Functional

  3. COVID-19 Yorkshire Rehab Screen

    Time frame: 6-months post ICU admission

    Physical function; cognition; quality of life; disease symptoms

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Geoff Strong, PT, MS

CONTACT

[email protected]

905-522-1155 ext. 33242

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: REVIVe

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2022
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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