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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05246098
Acronym
REVIVe
Enrollment
900
Registered
2022-02-18
Start date
2022-08-24
Completion date
2025-10-01
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Respiratory Disease, Viral Infection

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.

Interventions

None listed

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Canadian Critical Care Trials Group
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Frailty Score (Adults)hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admissionFrailty
Functional Status Score (Pediatrics)hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post PICU admissionFrailty (paediatrics)

Secondary

MeasureTime frameDescription
COVID-19 Yorkshire Rehab Screen6-months post ICU admissionPhysical function; cognition; quality of life; disease symptoms
Katz activities of daily living (ADL; adults)hospital discharge or 6-months post ICU admission, whichever occurs first; 6-months post ICU admissionPhysical Functional
Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale6-months post PICU admissionQuality 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.
Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale6-months post PICU admissionQuality 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.
EQ5D-5L (EuroQoL; Adults)6-months post ICU admissionPhysical Functional

Countries

Canada

Contacts

Primary ContactGeoff Strong, PT, MS
revive@mcmaster.ca905-522-1155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026