Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001114932p
Ethics application status
Submitted, not yet approved
Date submitted
9/10/2020
Date registered
28/10/2020
Date last updated
28/10/2020
Date data sharing statement initially provided
28/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Morbidity Post COVID-19 - Investigation and call to action
Scientific title
Morbidity Post COVID-19 - Investigation and call to action
Secondary ID [1] 302494 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 319346 0
Respiratory dysfunction - including dyspnoea, reduced lung function and lung volumes 319347 0
Post-viral cognitive dysfunction 319348 0
Post-viral depression 319349 0
Post-viral muscle atrophy 319350 0
Post-viral anxiety 319351 0
Condition category
Condition code
Respiratory 317305 317305 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 317306 317306 0 0
Physiotherapy
Physical Medicine / Rehabilitation 317307 317307 0 0
Occupational therapy
Mental Health 317308 317308 0 0
Anxiety
Mental Health 317309 317309 0 0
Depression
Mental Health 317332 317332 0 0
Studies of normal psychology, cognitive function and behaviour
Infection 317496 317496 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research will conduct observational measures to detect impairments that may be present as a direct result of COVID-19 infection. Participants involved will have had a positive COVID-19 test along with a hospital admission to an actual ward or virtual ward. Participants involved will also have recovered from coronavirus infection and will now no longer have a positive coronavirus test.
Participants will attend the Physiotherapy and Thoracic Medicine Departments for a total of 4 visits over a 6-month period (Every 2 months post initial visit on recruitment). Each participant will be required for a total of 1-hour for each visit, total of 4 hours over a 6-month period.
During the visit the participants will undergo the following observational tests:
- Respiratory Function Testing (Spirometry) - 15 minutes
- 6 Minute Walk Test (Physical fitness) - 8 minutes
- Ultrasound of rectus femoris muscle (Muscle cross sectional area) - 5 minutes
- FIM (Physical function) - 5 minutes
- Short Form-36 Questionnaire (Quality of Life) - 5 minutes
- The Zung Self-rated Anxiety Scale (Anxiety) - 5 Minutes
- The Zung Self-rated Depression Scale (Depression) 5 minutes
- Montreal Cognitive Assessment (Cognitive Function) 10 minutes
Intervention code [1] 318797 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325374 0
Change in respiratory function test results
- Spirometry (FEV1, FVC)
- Diffusion capacity for carbon monoxide (DLCO) will be measured by a respiratory technician in the thoracic medicine department. DLCO will be performed using a portable single breath DLCO device.
Timepoint [1] 325374 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint
Secondary outcome [1] 387703 0
Changes in Physical fitness
- Cardiovascular fitness using 6 Minute Walk Test
Timepoint [1] 387703 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint
Secondary outcome [2] 387704 0
Changes in muscle cross sectional area as measured by ultrasound
- Specifically rectus femoris muscle
Timepoint [2] 387704 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint
Secondary outcome [3] 387705 0
Changes in physical function
- Using Functional Independence Measure (FIM)
Timepoint [3] 387705 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint
Secondary outcome [4] 387706 0
Changes in quality of life
- Using SF-36
Timepoint [4] 387706 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint
Secondary outcome [5] 387707 0
Changes in mental health - anxiety
- Using The Zung Self-Rating Anxiety Scale
Timepoint [5] 387707 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint
Secondary outcome [6] 387708 0
Changes in mental health - depression
- Using The Zung Self-Rating Depression Scale
Timepoint [6] 387708 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint
Secondary outcome [7] 387709 0
Changes in cognitive function
- Using Montreal Cognitive Assessment
Timepoint [7] 387709 0
4 measured time points over a 6 month-period.
Initial timepoint - On recruitment
Second Visit - 2 Months post initial timepoint
Third Visit - 4 Months post initial timepoint
Fourth visit - 6 Months post initial timepoint

Eligibility
Key inclusion criteria
Inclusion criteria will be all patients who tested positive for COVID-19, greater than 18 years
and who were monitored or admitted to Metro North during 2020. This includes patients admitted to intensive care, the COVID-19 wards at RBWH and those patients in the Metro North “Virtual Ward”.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The data will be tested for normality and logarithmic transformation performed if required. An ANOVA will compare outcomes over time between the three groups related to severity of COVID-19, using the premorbid Charleson Comorbidity Score as a confounder.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2020
Actual
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
30/07/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17802 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 17803 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 31659 0
4029 - Herston
Recruitment postcode(s) [2] 31660 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 306920 0
Charities/Societies/Foundations
Name [1] 306920 0
RBWH Foundation
Country [1] 306920 0
Australia
Primary sponsor type
Hospital
Name
The Royal Brisbane and Women's Hospital
Address
Butterfield St, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 307481 0
University
Name [1] 307481 0
Griffith University
Address [1] 307481 0
170 Kessels Road, Nathan, Queensland, 4111
Country [1] 307481 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307070 0
Metro North Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 307070 0
Lower ground floor, Executive Offices
James Mayne Building
Butterfield Street
HERSTON QLD 4029
Ethics committee country [1] 307070 0
Australia
Date submitted for ethics approval [1] 307070 0
31/08/2020
Approval date [1] 307070 0
Ethics approval number [1] 307070 0

Summary
Brief summary
The aim of this project is to document over a period of a six-month period the post morbidity problems including pulmonary, functional, neurocognitive and health related quality of life for those patients infected with COVID-19. Results will be compared between severity levels of the infection (mild, severe and critical) and adjusted for the premorbid age adjusted Charleson Comorbidity Score. It is hypothesised those subjects with a positive diagnosis of COVID -19 will have abnormal results when compared to population norms in pulmonary function, functional ability, neurocognitive status and health related quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105922 0
Dr Jennifer Paratz
Address 105922 0
Royal Brisbane & Women’s Hospital
Physiotherapy Department
Level 2, Ned Hanlon Building
Butterfield Street, Brisbane, QLD, 4029
Country 105922 0
Australia
Phone 105922 0
+61 073646 2581
Fax 105922 0
Email 105922 0
[email protected]
Contact person for public queries
Name 105923 0
Dr Jennifer Paratz
Address 105923 0
Royal Brisbane & Women’s Hospital
Physiotherapy Department
Level 2, Ned Hanlon Building
Butterfield Street, Brisbane, QLD, 4029
Country 105923 0
Australia
Phone 105923 0
+61 073646 2581
Fax 105923 0
Email 105923 0
[email protected]
Contact person for scientific queries
Name 105924 0
Dr Jennifer Paratz
Address 105924 0
Royal Brisbane & Women’s Hospital
Physiotherapy Department
Level 2, Ned Hanlon Building
Butterfield Street, Brisbane, QLD, 4029
Country 105924 0
Australia
Phone 105924 0
+61 073646 2581
Fax 105924 0
Email 105924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.