Clinical trial NCT04602260: Functional Recovery of Hospitalised Patients With COVID-19: The COREG Extension Study
Official title: Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Corona Virus Infection
Mobility Limitation
Frailty
Keywords: mobility
functional recovery
pulmonary function
Covid-19
coronavirus
health outcomes
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients included in the COREG registry that meet inclusion criteria will be approached for enrollment in this extension study.

Brief summary: Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Although there has been a rapid response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Older adults who survive the diseases are at risk of developing persistent mobility limitations due to extensive bed rest during hospitalization. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.

Detailed description: The coronavirus disease of 2019 (COVID-19) is an international public health challenge with far-reaching social, economic and health impacts. Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Of the 15,381 reported cases of COVID-19 in Ontario to date, approximately 22.2% (n=3,420) are aged 60-79 and 22.4% (n=3,443) are 80 and over. Although there has been a rapid and coordinated response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Anecdotally, the investigators are seeing severe declines in function, persistent symptoms, and new and worsening chronic conditions among older survivors of COVID-19. It is known that older adults who survive acute respiratory distress syndrome and associated diseases are at risk of developing persistent mobility limitations due to extensive bed rest and/or long stays in the intensive care unit (ICU) during hospitalization. Recent studies have shown that many older patients spend only 4% of their hospital stay out of bed, and each day in bed is associated with a 1-5% loss in muscle strength. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility; with further losses in physiological reserve and resilience. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.

This study is an extension of the Coronavirus (COVID-19) Registry (COREG) platform (PI Andrew Costa)- a unique Kitchener-Waterloo-Hamilton registry of suspected and confirmed COVID-19 hospital admissions based on (and in collaboration with) the WHO International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). The addition of a prospective cohort study extension to COREG will allow the investigators to follow-older hospitalised COVID-19 patients over the longer-term in order to gain an understanding of the trajectory of functional recovery of the disease. Combining the primary data collection with COREG will also allow the investigators to identify determinants of long-term outcomes for at-risk older adults. These data are necessary to guide the clinical care and optimal management of older patients who survive serious COVID-19 illness.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Currently hospitalised/recently discharged due to/since confirmed or suspected COVID- 19 infection using the ISARIC definition.

Exclusion Criteria:

* Previously institutionalized
* Pre-morbid severe mobility limitation

Primary outcomes:
measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version
timeFrame: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)
measure: Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version
timeFrame: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function), and at 3,6,9 and 12-months post hospital discharge
measure: Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version
timeFrame: Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)
measure: Change in Activity Measure for Post Acute Care (AM-PAC) Daily Activity
timeFrame: 3,6,9 and 12-months post hospital discharge
Secondary outcomes:
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Clinical Frailty Scale (CFS) for participants over 60 years of age
timeFrame: Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function ), and at 3,6,9 and 12-months post hospital discharge
measure: Change in Forced Expiratory Volume (FEV1)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Forced Expiratory Volume Percentage (FEV1%)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Functional Independence Measure (FIM)
timeFrame: 3 and 6 months post hospital discharge
measure: Change in Impact of Event Scale - Revised (IES-R)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Health status (EQ-5D-5L)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Post-COVID-19 Functional Status Scale (PCFSS)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Fatigue Visual Analog Scale (Fatigue VAS)
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Modified Medical Research Council (MRC) Breathlessness Scale
timeFrame: 3,6,9 and 12-months post hospital discharge
measure: Change in Oxygen Saturation (SpO2)
timeFrame: 3,6,9 and 12-months post hospital discharge
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Marla K Beauchamp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reid JC, Costa AP, Duong M, Ho T, Kruisselbrink R, Raina P, Kirkwood R, Jones A, Corriveau S, Griffith LE, Haider S, Marcucci M, Markle-Reid M, Morrison H, Raghavan N, Schumacher C, Vrkljan B, Junek M, Martin L, Patel A, Girolametto C, Pitre T, Beauchamp MK; COREG Investigators. Functional recovery following hospitalisation of patients diagnosed with COVID-19: a protocol for a longitudinal cohort study. BMJ Open. 2021 Dec 13;11(12):e053021. doi: 10.1136/bmjopen-2021-053021.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.