Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001572156
Ethics application status
Approved
Date submitted
30/10/2019
Date registered
14/11/2019
Date last updated
10/09/2020
Date data sharing statement initially provided
14/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
National Breathlessness Survey (Australia)
Scientific title
National Breathlessness Survey (Australia); an observational study of breathlessness in Australian adults
Secondary ID [1] 299560 0
None
Universal Trial Number (UTN)
U1111-1242-0956
Trial acronym
NBS (National Breathlessness Survey)
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
breathlessness 314829 0
asthma 314830 0
chronic obstructive pulmonary disease (COPD) 314831 0
Condition category
Condition code
Respiratory 313166 313166 0 0
Asthma
Respiratory 313167 313167 0 0
Chronic obstructive pulmonary disease
Respiratory 313177 313177 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross-sectional study of prevalence of breathlessness (as measured by mMRC scale of dyspnoea score) in a population sample of Australian adults. Thus far, the median length time taken to complete the survey is approximately 14 minutes.
Intervention code [1] 315817 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321690 0
The percentage of the Australian population with mMRC breathlessness/dyspnoea score greater than or equal to 1.
Timepoint [1] 321690 0
At the time of the survey
Secondary outcome [1] 376162 0
prevalence of breathlessness (mMRC breathlessness/dyspnoea score 1+) in adults with and without a diagnosis of lung disease (determined by study-specific survey)
Timepoint [1] 376162 0
At the time of the survey
Secondary outcome [2] 376391 0
Frequency of breathlessness - continuous or intermittent (determined by study-specific survey)
Timepoint [2] 376391 0
at the time of the survey
Secondary outcome [3] 376392 0
impact of breathlessness - Dyspnoea-12
Timepoint [3] 376392 0
at the time of the survey
Secondary outcome [4] 376393 0
prevalence of smoking - study-specific survey
Timepoint [4] 376393 0
lifetime, assessed at time of survey
Secondary outcome [5] 376397 0
health care utilisation among people with breathlessness (assessed using study-specific survey)
Timepoint [5] 376397 0
over the last 12 months, assessed at the time of the survey
Secondary outcome [6] 376399 0
Medication use among people with breathlessness (assessed using study-specific survey)
Timepoint [6] 376399 0
in last 12 months, assessed at the time of the survey
Secondary outcome [7] 376400 0
prevalence of respiratory disease (other than asthma and COPD) that may be associated with breathlessness (determined by study-specific survey)
Timepoint [7] 376400 0
assessed at the time of the survey
Secondary outcome [8] 376663 0
prevalence of breathlessness (mMRC breathlessness/dyspnoea score 1+) in adults with and without a diagnosis of cardiovascular disease (determined by study-specific survey
Timepoint [8] 376663 0
assessed at the time of the survey
Secondary outcome [9] 376664 0
impact of breathlessness - SF-1
Timepoint [9] 376664 0
assessed at the time of the survey
Secondary outcome [10] 376666 0
impact of breathlessness - EuroQol-5L-5D
Timepoint [10] 376666 0
assessed at the time of the survey
Secondary outcome [11] 376667 0
impact of breathlessness - patient health questionnaire-4
Timepoint [11] 376667 0
assessed at the time of the survey
Secondary outcome [12] 376668 0
prevalence of exposure to tobacco smoke
Timepoint [12] 376668 0
lifetime, assessed at time of survey
Secondary outcome [13] 376669 0
prevalence of exposure to dust or fumes (study-specific survey)
Timepoint [13] 376669 0
lifetime, assessed at the time of the survey
Secondary outcome [14] 376670 0
prevalence of living near a main road (study-specific survey)
Timepoint [14] 376670 0
lifetime, assessed at the time of the survey
Secondary outcome [15] 376671 0
prevalence of cardiovascular disease (assessed using study-specific survey)
Timepoint [15] 376671 0
assessed at the time of the survey
Secondary outcome [16] 376672 0
prevalence of obesity/overweight (assessed by BMI calculated from self-reported height and weight)
Timepoint [16] 376672 0
assessed at the time of the survey
Secondary outcome [17] 376673 0
prevalence of anxiety/depression (assessed using study-specific survey)
Timepoint [17] 376673 0
assessed at the time of the survey

Eligibility
Key inclusion criteria
Age 18 years or over
Resident of Australia
Member of an existing, large web-based Australian survey panel.

*please note that this study is a random population survey, so volunteers cannot be accepted*
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria.

Study design
Purpose
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
14/10/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
30/10/2019
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
30000
Accrual to date
10072
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304046 0
Commercial sector/Industry
Name [1] 304046 0
GlaxoSmithKline
Country [1] 304046 0
Australia
Funding source category [2] 304140 0
Commercial sector/Industry
Name [2] 304140 0
AstraZeneca
Country [2] 304140 0
Australia
Funding source category [3] 304141 0
Commercial sector/Industry
Name [3] 304141 0
Novartis
Country [3] 304141 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] 304371 0
None
Name [1] 304371 0
Address [1] 304371 0
Country [1] 304371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304536 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 304536 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 304536 0
Australia
Date submitted for ethics approval [1] 304536 0
21/06/2019
Approval date [1] 304536 0
05/08/2019
Ethics approval number [1] 304536 0
2019/621

Summary
Brief summary
The aim of the National Breathlessness Survey is to evaluate respiratory symptom burden (breathlessness, cough, wheeze and/or chest tightness), treatment, healthcare utilisation and patient attitudes and beliefs in a randomly selected adult population, irrespective of any current diagnostic assignment.
Specifically, the National Breathlessness Survey aims to:
• Describe the prevalence (and severity) of breathlessness in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis, or cardiac disease.
• Describe the frequency of breathlessness and the impact of breathlessness on quality of life in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis or cardiac disease.
• Quantify how many people have exposure to known risk factors for developing breathlessness or experiencing adverse health outcomes of contributory conditions, including the presence of comorbidities (e.g. exposure to tobacco products, occupational exposure to fumes, dust and asthmagens, inactivity/obesity).
• Assess healthcare utilisation among people with breathlessness.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97306 0
Prof Helen Reddel
Address 97306 0
Australian Centre for Airways disease Monitoring (ACAM)
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2037
Australia
Country 97306 0
Australia
Phone 97306 0
+61 2 9114 0437
Fax 97306 0
+61 2 9114 0011
Email 97306 0
[email protected]
Contact person for public queries
Name 97307 0
Prof Helen Reddel
Address 97307 0
Australian Centre for Airways disease Monitoring (ACAM)
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2037
Australia
Country 97307 0
Australia
Phone 97307 0
+61 2 9114 0437
Fax 97307 0
+61 2 9114 0011
Email 97307 0
[email protected]
Contact person for scientific queries
Name 97308 0
Prof Helen Reddel
Address 97308 0
Australian Centre for Airways disease Monitoring (ACAM)
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2037
Australia
Country 97308 0
Australia
Phone 97308 0
+61 2 9114 0437
Fax 97308 0
+61 2 9114 0011
Email 97308 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-dentified 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.