Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- McMaster University
- Enrollment
- 211
- Locations
- 1
- Primary Endpoint
- Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Marla Beauchamp
Assistant Professor
McMaster University
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
Outcomes
Primary Outcomes
Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version
Time Frame: 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)
The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version
Time Frame: 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
The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Change in Activity Measure for Post Acute Care (AM-PAC) Daily Activity
Time Frame: 3,6,9 and 12-months post hospital discharge
The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version
Time Frame: 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)
The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.
Secondary Outcomes
- Change in Functional Independence Measure (FIM)(3 and 6 months post hospital discharge)
- Change in Impact of Event Scale - Revised (IES-R)(3,6,9 and 12-months post hospital discharge)
- Change in Short Physical Performance Battery (SPPB)(3,6,9 and 12-months post hospital discharge)
- Change in Forced Expiratory Volume Percentage (FEV1%)(3,6,9 and 12-months post hospital discharge)
- Change in Health status (EQ-5D-5L)(3,6,9 and 12-months post hospital discharge)
- Change in Fatigue Visual Analog Scale (Fatigue VAS)(3,6,9 and 12-months post hospital discharge)
- Change in Forced Vital Capacity (FVC)(3,6,9 and 12-months post hospital discharge)
- Change in Clinical Frailty Scale (CFS) for participants over 60 years of age(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)
- Change in Forced Expiratory Volume (FEV1)(3,6,9 and 12-months post hospital discharge)
- Change in Hospital Anxiety and Depression Scale (HADS)(3,6,9 and 12-months post hospital discharge)
- Change in Oxygen Saturation (SpO2)(3,6,9 and 12-months post hospital discharge)
- Change in Post-COVID-19 Functional Status Scale (PCFSS)(3,6,9 and 12-months post hospital discharge)
- Change in Modified Medical Research Council (MRC) Breathlessness Scale(3,6,9 and 12-months post hospital discharge)