None listed
Conditions
Brief summary
Project Summary In the majority of cases coronavirus disease (COVID-19) people present with signs and symptoms of respiratory tract infection including fever, cough, fatigue, dyspnoea, and sputum production. Although the majority of COVID-19 cases have mild to moderate disease, approximately 15% will develop severe or critical disease that requires intensive medical management or admission to an intensive care unit (ICU). Medical management in ICU often includes use of sedation, neuromuscular blocking agents and prolonged mechanical ventilation. Given the nature of the disease process and the treatment required, those affected by severe COVID-19 infection are at risk of long-term sequelae that can potential to affect long-term health and wellbeing. These sequelae include symptoms such as fatigue and shortness of breath, ongoing weakness and reduced physical function due to ICU-acquired weakness (ICUAW) and impaired psychological function. It is essential to provide an in-depth multidimensional description of recovery trajectories during and following the acute phase of the disease from a symptom, physical and psychological perspective. The main aim of this study will be to provide a multidimensional analysis of recovery in people with severe (or critical) COVID-19 during the first 12 months following diagnosis. Specific objectives are to: (i) document recovery trajectories during and following the acute phase of the disease from a symptom, physical and psychological perspective; and (ii) identify factors associated with prolonged recovery.
Interventions
Patients with suspected (control) or confirmed COVID-19 were studied for 12 months after diagnosis. The study involved physical (1-minute sit-to-stand test [1-STS]; grip strength) and PROM measures (Modified medical research council dyspnoea scale, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Impact of Events Scale, EQ-5D-5L) repeated at 3 time points in the year (3, 6 and 12 months) after attending a health facility in Perth, Western Australia. All participants completed study physical and survey assessments on the same day with remote (via video or phone) and face-to-face options available to reduce the patient burden and minimise transmission of infection. (Grip strength and oxygen saturation for the 1-STS were not collected if patients were assessed outside the hospital environment.) A research physiotherapist or trained research assistant conducted the assessments and each session took approximately 30-40 minutes. Data were collected prospectively from June 2020 and will be analysed retrospectively.
Sponsors
Eligibility
Inclusion criteria
Participant inclusion criteria: Patients were eligible to participate if they are: (i) >= 18 years old, (ii) attended the recruitment sites with a confirmed or suspected diagnosis of COVID-19, and (iii) were recruited into or data is captured as per waiver of consent provisions in the ISARIC / WHO study (RGS3976). Hospitalised patients who did not consent to the ISARIC / WHO study were eligible for recruitment to the LATER-19 trial and were offered the opportunity to consent using the appropriate documents at time of recruitment or immediately prior to first assessment (in person or remote via video conference).
Exclusion criteria
Participant exclusion criteria: Participants were excluded with preexisting neuromuscular disorders thought to affect the measures of physical function including previous cerebrovascular incidents, muscle or bony injury within the last three months, or pre-existing disorders such as Parkinson’s Disease; preexisting mental illness,; and, significant communication or cognitive impairment thought to affect responses to self-report measures.