Functional Recovery of Hospitalised Patients With COVID-19: The COREG Extension Study

• ClinicalTrials.gov Identifier: NCT04602260
• Recruitment Status: Recruiting
• First Posted: October 26, 2020
• Last Update Posted: August 24, 2021
• Sponsor: McMaster University
• Information provided by (Responsible Party): Marla Beauchamp, McMaster University

Study Description

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.

Condition or disease
Covid19; Corona Virus Infection; Mobility Limitation; Frailty

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 211 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)
• Actual Study Start Date: June 9, 2020
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Groups and Cohorts

Group/Cohort
Prospective Cohort; The prospective cohort will assess patients upon admission to general internal medicine, at hospital discharge, and at 3, 6, 9, and 12-month follow-up.
Retrospective Cohort; The retrospective cohort will assess patients at 3, 6, 9, and 12-months after being discharged from the hospital.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. Change in Short Physical Performance Battery (SPPB) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
   The SPPB combines the results of gait speed over 3 meters, the 5-repetition chair-stand, and a progressive balance test to assess lower extremity function.
2. Change in Clinical Frailty Scale (CFS) for participants over 60 years of age [ 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 CFS is an interview-based scale wherein the assessor may ask the participant questions about things such as a participant's independence or physical abilities to determine where the participant falls along the 9-point scale, from 1 (Very Fit) to 9 (Terminally Ill).
3. Change in Forced Expiratory Volume (FEV1) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
   The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation as measured by spirometry.
4. Change in Forced Vital Capacity (FVC) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
   The amount of air that can be forcibly exhaled from a participant's lungs after taking the deepest breath possible, as measured by spirometry. FVC is the total amount of air exhaled during the FEV test.
5. Change in Forced Expiratory Volume Percentage (FEV1%) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
   The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value.
6. Change in Functional Independence Measure (FIM) [ Time Frame: 3 and 6 months post hospital discharge ]
   The FIM assesses the functional status of a person based on the level of assistance the person requires.
7. Change in Impact of Event Scale - Revised (IES-R) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
   The IES-R is a 22-item self-report measure that asks questions about subjective distress caused by traumatic events. Each item is rated on a 5-point scale, from 0 ("not at all") to 4 ("extremely").
8. Change in Health status (EQ-5D-5L) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
   The EQ-5D-5L is a generic and well-established instrument for describing health status or disease-specific outcome measures. It defines health in terms of five dimensions: Mobility, Self- Care, Usual Activities, Pain/Discomfort, and Anxiety/ Depression. The response options are of five levels, from no, slight, moderate, severe, to extreme problems
9. Change in Post-COVID-19 Functional Status Scale (PCFSS) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
   Developed in early 2020, this 5-point scale assesses how individuals have been affected in a participant's everyday life by COVID-19 illness and recovery. Lower grades indicate better functioning, with grade 0 representing the absence of symptoms or functional limitations and grade 4 reflecting severe limitations and symptom burden. The PCFSS can be patient-reported following a flow diagram series of questions to result in a grade, or it can be administered via structured interview, which is more comprehensive. The research team will conduct the structured interview over the phone and the patient-reported flow chart during the home visits.
10. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
    The HADS is a 14-item two-dimension scale that identifies depression and anxiety among physically ill patients. Scores range from 0 to 21, with higher scores indicating higher levels of anxiety. In the general ill population, a cut-off of ≥8 indicates depression.
11. Change in Fatigue Visual Analog Scale (Fatigue VAS) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
    This visual scale allows individuals to rate a participant's global fatigue from 0 (worst fatigue) to 10 (normal).
12. Change in Modified Medical Research Council (MRC) Breathlessness Scale [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
    This brief questionnaire contains five statements describing a range of breathlessness from only becoming breathless with strenuous exercise to being too breathless to leave the house.
13. Change in Oxygen Saturation (SpO2) [ Time Frame: 3,6,9 and 12-months post hospital discharge ]
    Oxygen saturation will be measured using a fingertip pulse oximeter to detect hypoxia and to evaluate any persistent hypoxia post-COVID-19 illness.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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

Contacts and Locations

Contacts

Contact: Hope Morrison, BA; 905-525-9140 ext 20810; morrih12@mcmaster.ca

Locations

Canada, Ontario

McMaster University; Recruiting

Hamilton, Ontario, Canada, L8S1C7

Contact: Hope Morrison, BA 905-525-9140 ext 20810 morrih12@mcmaster.ca

Sponsors and Collaborators

McMaster University

Investigators

• Principal Investigator: Marla K Beauchamp, PhD; McMaster University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

• Responsible Party: Marla Beauchamp, Assistant Professor, McMaster University
• ClinicalTrials.gov Identifier: NCT04602260
• Other Study ID Numbers: COREG-Extension_14567
• First Posted: October 26, 2020
• Last Update Posted: August 24, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marla Beauchamp, McMaster University:

mobility; functional recovery; pulmonary function; Covid-19; coronavirus; health outcomes

Additional relevant MeSH terms:

COVID-19; Coronavirus Infections; Frailty; Mobility Limitation; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes