Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001067864
Ethics application status
Approved
Date submitted
20/07/2021
Date registered
13/08/2021
Date last updated
28/10/2021
Date data sharing statement initially provided
13/08/2021
Date results information initially provided
13/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Life AfTER COVID-19 (LATER-19) - an observational study
Scientific title
Life AfTER COVID-19 (LATER-19): a prospective, longitudinal, cohort study of symptoms, physical function and psychological outcomes in a Western Australian population
Secondary ID [1] 304833 0
Nil known
Universal Trial Number (UTN)
U1111-1268-2350
Trial acronym
LATER-19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 322920 0
Condition category
Condition code
Infection 320493 320493 0 0
Other infectious diseases
Respiratory 320556 320556 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 321213 0
Diagnosis / Prognosis
Comparator / control treatment
Control patients were recruited after attending ambulatory clinics, ED or admitted to hospital with suspected COVID-19. They were recruited based on their attendance at the same time as COVID-19 confirmed patients. Control patients completed the same assessments as the COVID-19 positive participants.
Control group
Active

Outcomes
Primary outcome [1] 328322 0
Physical function - functional capacity - 1 minute sit-to-stand test.
Timepoint [1] 328322 0
3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).
Primary outcome [2] 328323 0
Health-related quality of life - EQ5D-5L
Timepoint [2] 328323 0
3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).
Secondary outcome [1] 398591 0
Feelings of anxiety and depression - Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 398591 0
3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).
Secondary outcome [2] 398592 0
Posttraumatic stress - Impact of Events Scale – 6 (IES-6)
Timepoint [2] 398592 0
3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).
Secondary outcome [3] 398593 0
Symptom – shortness of breath - Modified medical research council dyspnoea scale - mMRC survey
Timepoint [3] 398593 0
3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).
Secondary outcome [4] 398594 0
Symptom - fatigue - Fatigue Severity Scale (FSS)
Timepoint [4] 398594 0
3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).
Secondary outcome [5] 398815 0
Length of stay - hospital (sourced from electronic data system - WebPAS).
Timepoint [5] 398815 0
At discharge from acute hospital
Secondary outcome [6] 398816 0
Length of stay - ICU (sourced from electronic data system - WebPAS).
Timepoint [6] 398816 0
At discharge from acute hospital
Secondary outcome [7] 398817 0
Grip strength (left and right) - dynamometry measured in triplicate
Timepoint [7] 398817 0
3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Statistical analysis
Descriptive summaries will include means ± SD or medians [interquartile ranges] for continuous data and frequency distributions for categorical data. Comparisons of patient baseline characteristics (gender, age, comorbidities) and clinical characteristic data by disease severity (mild or severe/critical) will be undertaken using parametric independent t-tests or oneway ANOVAs for normally distributed continuous data and non-parametric Mann-Whitney U or Kruskall-Wallis H tests for continuous data not confirmed to display a normal distribution and Chi-squared or Fisher’s Exact tests, as appropriate, for categorical data.

Associations of patient and clinical characteristic predictors with longitudinal in-hospital symptomatic and physical functioning outcomes (including 1STS, handgrip force) will be examined using generalised linear mixed models (GLMM) with random subject effects, adjusting for disease severity, length of stay in ICU and in hospital, and selected baseline (admission) characteristics. Associations of patient characteristic, clinical pathway and rehabilitation pathway predictors with post-discharge recovery trajectories (including 1STS, FSS, MMRC, EQ-5D-5L, HADS, IES-6 and clinical sequalae) will be examined using GLMM with random subject effects, adjusting for disease severity and selected baseline (discharge) characteristics. All models will be implemented as univariable and predictive multivariable models, with all covariates univariately significant at alpha=0.15 considered as candidate predictors in the multivariable models. Results will be summarised using estimated marginal means and 95% CI for continuous outcomes or odds ratios (OR) and 95% CI for categorical outcomes. Model fit will be assessed using residuals checking and cross-validation of models will be undertaken by splitting the dataset to form training and test sets if the sample is large. Missing data points in longitudinal data will be accounted for by the use of maximum likelihood estimation (MLE) methods in the models. Temporal outcomes including time to death and time to discharge in the in-hospital analysis and time to reach recovery milestones, defined according to EQ5D age and gender appropriate norms, in post-discharge analysis will be assessed using Kaplan-Meier survival probabilities and compared between relevant patient characteristic, clinical pathway and rehabilitation pathway predictors using Log rank tests. Effects of these predictors on temporal outcomes will be examined using Cox proportional hazards regression models, censoring at 12 months post-admission and adjusting for relevant baseline patient and clinical characteristics. Results will be summarised using hazard ratios (HR) and 95% CI. Sensitivity analyses will be performed on patients who are engaged in any other forms of exercise/wellbeing apps/activities and those who are not.
Stata MP version 16.0 (StataCorp LP, College Station, TX) will be used for data analysis. All hypotheses will be two-sided and significance will be set at alpha=0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/05/2020
Date of last participant enrolment
Anticipated
Actual
30/10/2020
Date of last data collection
Anticipated
29/10/2021
Actual
4/10/2021
Sample size
Target
450
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20033 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 20034 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 20035 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 34742 0
6000 - Perth
Recruitment postcode(s) [2] 34743 0
6009 - Nedlands
Recruitment postcode(s) [3] 34741 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 309206 0
Other Collaborative groups
Name [1] 309206 0
Western Australian Health Translation Network
Country [1] 309206 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150.
Country
Australia
Secondary sponsor category [1] 310168 0
Other Collaborative groups
Name [1] 310168 0
Western Australian Health Translation network (WAHTN)
Address [1] 310168 0
The Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009
Country [1] 310168 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309058 0
South Metropolitan Health Service HREC
Ethics committee address [1] 309058 0
Education Building, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150
Ethics committee country [1] 309058 0
Australia
Date submitted for ethics approval [1] 309058 0
30/04/2020
Approval date [1] 309058 0
29/05/2020
Ethics approval number [1] 309058 0
RGS0000004040

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Please feel free to reach out and consider comparison studies with all or any of the study outcomes collected in our study. We are collecting all of our outcomes at 3, 6 and 12 months after attendance at our recruitment facilities with PCR negative (suspected) or confirmed COVID19 disease.

The Western Australian Health Translation Network (WAHTN) is a state-wide collaborative network of WA’s universities, medical research institutes, public and private hospitals, PathWest and the WA Department of Health.

Contacts
Principal investigator
Name 112822 0
A/Prof Dale Edgar
Address 112822 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150.
Country 112822 0
Australia
Phone 112822 0
+61 413070384
Fax 112822 0
Email 112822 0
dale.edgar@health.wa.gov.au
Contact person for public queries
Name 112823 0
A/Prof Dale Edgar
Address 112823 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150.
Country 112823 0
Australia
Phone 112823 0
+61 413070384
Fax 112823 0
Email 112823 0
dale.edgar@health.wa.gov.au
Contact person for scientific queries
Name 112824 0
A/Prof Dale Edgar
Address 112824 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150.
Country 112824 0
Australia
Phone 112824 0
+61 413070384
Fax 112824 0
Email 112824 0
dale.edgar@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All trial data could be made available - deidentified.
When will data be available (start and end dates)?
April 2020 - October 2021
Available to whom?
Researchers interested in collaborative comparisons.
Due to the sensitive nature of the data, joint publication (co-authorship) will be a condition of sharing the data.
Available for what types of analyses?
LATER19 cohort IPD will be available for appropriate comparisons with other COVID-19 cohorts
How or where can data be obtained?
Data will only be made available with the appropriate Ethics approvals and Data Sharing Agreements as approved by the sponsor - South Metropolitan Health Service HREC.
Email Principle Investigator for details - dale.edgar@health.wa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12618Study protocolLife AfTER covid-19 (LATER-19): a protocol for a prospective, longitudinal, cohort study of symptoms, physical function and psychological outcomes in the context of a pandemic Dale W. Edgar, Paul Gittings, Lisa Van der Lee, Louise Naylor, Andrew Maiorana, Angela Jacques, Vinicius Cavalheri on behalf of the LATER-19 Co-investigator Group. Tasman Medical Journal 2021; 3(1); 1-10https://tasmanmedicaljournal.com/issues/3/3-1/dale.edgar@health.wa.gov.au N/A 382441-(Uploaded-20-07-2021-18-53-44)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.