Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000977976p
Ethics application status
Submitted, not yet approved
Date submitted
24/08/2020
Date registered
30/09/2020
Date last updated
30/09/2020
Date data sharing statement initially provided
30/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
National Asthma Treatment Survey in Australian adults
Scientific title
National Survey of Difficult to Treat and Severe Asthma- a cross-sectional observational study in Australian adults
Secondary ID [1] 302121 0
Nil known
Universal Trial Number (UTN)
U1111-1257-3764
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 318746 0
difficult to treat asthma 318747 0
severe asthma 318748 0
mental illness 318749 0
depression 318750 0
anxiety 318751 0
Respiratory 318752 0
Condition category
Condition code
Respiratory 316766 316766 0 0
Asthma
Mental Health 316767 316767 0 0
Depression
Mental Health 317164 317164 0 0
Anxiety
Public Health 317165 317165 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project will involve conducting a national, web-based survey to estimate the prevalence of difficult to treat and severe asthma in the Australian population, to explore their medication use, to quantify mental health issues experienced by people with difficult to treat or severe asthma, any mental health support received, and the impact of COVID-19
The survey will be one-off.
The survey was purpose designed for this study. Validated questionnaires will be included where available. These are (to be confirmed): ACT; Kessler/ DASS21/HADS; AIS-6; PAQ4; CARE empathy.
The time taken to complete the survey is approx. 10 minutes for those who do not satisfy the definition of difficult to treat or severe asthma, and 15 minutes for those who do.
Intervention code [1] 318421 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324887 0
Proportion of survey participants with difficult to treat or severe asthma
The definitions of difficult to treat and severe asthma that will be used for the primary outcome are those published by the Global Initiative for Asthma (GINA). (Global Initiative for Asthma. Difficult-to-treat and severe asthma in adolescent and adult patients - Diagnosis and Management. A GINA Pocket Guide for Health Professionals V2.0. GINA; 2019; www.ginasthma.org/severeasthma/.
The total survey was designed specifically for this study.
Timepoint [1] 324887 0
At time of survey
Secondary outcome [1] 386100 0
What is the utilisation of biological agents among people with asthma? Assessed using study specific survey
Timepoint [1] 386100 0
At time of survey
Secondary outcome [2] 386101 0
What is the prevalence of mental health issues such as anxiety and depression in people with difficult to treat asthma or severe asthma? Score for PHQ4
Timepoint [2] 386101 0
At time of survey
Secondary outcome [3] 386102 0
How do anxiety and depression impact the quality of life of people with difficult to treat asthma?
Score for AIS-6
Timepoint [3] 386102 0
At time of survey
Secondary outcome [4] 386103 0
Are the emotional support needs of people with difficult to treat asthma being met? Score for CARE empathy scale
Timepoint [4] 386103 0
At time of survey
Secondary outcome [5] 386104 0
What health service utilisation can be attributed to supporting the mental health needs of people with difficult to treat asthma? Assessed using study specific survey
Timepoint [5] 386104 0
At time of survey
Secondary outcome [6] 386105 0
What burden are systemic corticosteroids creating for people with difficult to treat asthma, including psychological effects? Assessed using study specific survey
Timepoint [6] 386105 0
At time of survey
Secondary outcome [7] 386106 0
What impact has COVID-19 had on people with difficult to treat or severe asthma? Assessed using study specific survey
Timepoint [7] 386106 0
At time of survey
Secondary outcome [8] 386118 0
Medication use in people with difficult to treat and severe asthma. Assessed using study specific survey
Timepoint [8] 386118 0
At time of survey

Eligibility
Key inclusion criteria
Aged 18 years or over
Australian resident
Current asthma
Randomly selected from an existing large web-based Australian survey panel
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None. Survey provider verifies participants with multiple integrity processes.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Descriptive and inferential statistics will be used to describe the sample population and to explore the relationship among variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
15/11/2020
Actual
Date of last data collection
Anticipated
15/11/2020
Actual
Sample size
Target
8000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306548 0
Government body
Name [1] 306548 0
National Health and Medical Research Council Severe Asthma Centre for Research Excellence
Country [1] 306548 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Rd
Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 307073 0
None
Name [1] 307073 0
Address [1] 307073 0
Country [1] 307073 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306738 0
University of Sydney HREC
Ethics committee address [1] 306738 0
Ethics committee country [1] 306738 0
Australia
Date submitted for ethics approval [1] 306738 0
18/08/2020
Approval date [1] 306738 0
Ethics approval number [1] 306738 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104850 0
Prof Helen Reddel
Address 104850 0
c/- Woolcock Institute of Medical Research
431 Glebe Point Rd'
Glebe NSW 2037
Country 104850 0
Australia
Phone 104850 0
+61 2 9114 0437
Fax 104850 0
61 2 9114 0010
Email 104850 0
[email protected]
Contact person for public queries
Name 104851 0
Sharon Davis
Address 104851 0
c/- Woolcock Institute of Medical Research
431 Glebe Point Rd'
Glebe NSW 2037
Country 104851 0
Australia
Phone 104851 0
+61 2 91140371
Fax 104851 0
61 2 91140010
Email 104851 0
[email protected]
Contact person for scientific queries
Name 104852 0
Helen Reddel
Address 104852 0
c/- Woolcock Institute of Medical Research
431 Glebe Point Rd'
Glebe NSW 2037
Country 104852 0
Australia
Phone 104852 0
+61 2 91140437
Fax 104852 0
61 2 91140010
Email 104852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results
When will data be available (start and end dates)?
2 years after article publication with no end date
Available to whom?
These data will be available to researchers who provide a methodologically sound proposal
Available for what types of analyses?
These data will be available only to achieve the aims outlined in the approved proposal.
How or where can data be obtained?
Data access will be subject to approval by Principal Investigator - Prof Helen Reddel - via email ([email protected]).
Proposals will be reviewed by the National Breathlessness Survey research team. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.


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.