ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

Physical function - functional capacity - 1 minute sit-to-stand test.

Timepoint [1]

3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).

Primary outcome [2]

Health-related quality of life - EQ5D-5L

Timepoint [2]

3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).

Secondary outcome [1]

Feelings of anxiety and depression - Hospital Anxiety and Depression Scale (HADS)

Timepoint [1]

3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).

Secondary outcome [2]

Posttraumatic stress - Impact of Events Scale – 6 (IES-6)

Timepoint [2]

3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).

Secondary outcome [3]

Symptom – shortness of breath - Modified medical research council dyspnoea scale - mMRC survey

Timepoint [3]

3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).

Secondary outcome [4]

Symptom - fatigue - Fatigue Severity Scale (FSS)

Timepoint [4]

3 months, 6 months and 12 months post-diagnosis of COVID-19 or attendance for suspected COVID-19 (controls).

Secondary outcome [5]

Length of stay - hospital (sourced from electronic data system - WebPAS).

Timepoint [5]

At discharge from acute hospital

Secondary outcome [6]

Length of stay - ICU (sourced from electronic data system - WebPAS).

Timepoint [6]

At discharge from acute hospital

Secondary outcome [7]

Grip strength (left and right) - dynamometry measured in triplicate

Timepoint [7]

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?

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)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [2]

Royal Perth Hospital - Perth

Recruitment hospital [3]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment postcode(s) [2]

6000 - Perth

Recruitment postcode(s) [3]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Western Australian Health Translation Network

Address [1]

The Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009

Country [1]

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]

Other Collaborative groups

Name [1]

Western Australian Health Translation network (WAHTN)

Address [1]

The Harry Perkins Institute of Medical Research
6 Verdun St, Nedlands WA 6009

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service HREC

Ethics committee address [1]

Education Building, Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/04/2020

Approval date [1]

29/05/2020

Ethics approval number [1]

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

A/Prof Dale Edgar

Address

Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150.

Country

Australia

Phone

+61 413070384

Fax

dale.edgar@health.wa.gov.au

Contact person for public queries

Name

Dale Edgar

Address

Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150.

Country

Australia

Phone

+61 413070384

Fax

dale.edgar@health.wa.gov.au

Contact person for scientific queries

Name

Dale Edgar

Address

Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, WA, 6150.

Country

Australia

Phone

+61 413070384

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
12618	Study protocol	Life 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); 1-10	https://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

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