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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Disease, COVID-19, Viral Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults<br>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<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Frailty Score (Adults) | Frailty | hospital discharge, 6-month hospital discharge | 
| Functional Status Score (Pediatrics) | Frailty (paediatrics) | PICU discharge; 6-months post-PICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Katz activities of daily living (ADL; adults) | Physical Functional | hospital discharge, approximately 28 days after enrolment | 
| EQ5D-5L (EuroQoL; Adults) | Physical Functional | hospital discharge, approximately 28 days after enrolment; 6-month hospital discharge | 
| COVID-19 Yorkshire Rehab Screen | Physical function; cognition; quality of life; disease symptoms | 6-months post-hospital discharge | 
| Pediatric Quality of Life Inventory (PedQL) - Multidimensional Fatigue Scale | 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 discharge | 
| Pediatric Quality of Life Inventory (PedQL) - General Well-being Scale | 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 discharge |