Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000748415
Ethics application status
Approved
Date submitted
11/04/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
THE PRIMARY BREATHE AUSTRALIA TRIAL: Breathlessness Self-Management in Primary Care
Scientific title
A Hybrid Effectiveness Implementation Randomised Controlled Trial of a Technology Enabled Non-Pharmacological Breathlessness Self-Management and Mastery Intervention in Australian Primary Care and Residential Aged Care
Secondary ID [1] 314192 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Lung Disease 337057 0
Interstitial lung disease 337058 0
Chronic asthma 337059 0
Bronchiectasis 337060 0
Lung cancer 337061 0
Condition category
Condition code
Respiratory 333501 333501 0 0
Asthma
Respiratory 333502 333502 0 0
Chronic obstructive pulmonary disease
Cancer 333503 333503 0 0
Lung - Mesothelioma
Cancer 334352 334352 0 0
Lung - Non small cell
Cancer 334353 334353 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms in the study, the Primary Breathe Australia self-management intervention (intervention arm) or usual care (control arm).

Participants assigned to the intervention arm will be entered into the Primary Breathe Australia self-management intervention.
The Primary Breathe Australia self-management intervention consists of at least 2, but up to 3, one-on-one clinical consultations delivered over an 8-week period (or shorter period according to patient preference) by the Primary Breathe Australia nurse who is embedded within the primary care or residential aged care site. Each consultation is expected to last 20-60 minutes and can be delivered face-to-face or via telehealth. The content of the interventions will involve patient assessment, general chronic breathlessness education, non-pharmacological self-management education, and provision of digital resources developed for the intervention. Adherence will be measured using post-consultation summaries.
Intervention code [1] 330796 0
Treatment: Other
Comparator / control treatment
Usual care - Usual care will vary broadly depending on the primary respiratory condition and includes may include pharmacological or non pharmacoligical investigations or therapies to assess or manage the underlying condition at the discretion of the participants usual treating clinicians.
Control group
Active

Outcomes
Primary outcome [1] 341079 0
change in Breathlessness Mastery
Timepoint [1] 341079 0
8 weeks post-randomisation
Secondary outcome [1] 446112 0
change in Breathlessness Mastery
Timepoint [1] 446112 0
4 weeks post-randomisation
Secondary outcome [2] 446115 0
change in Breathlessness Mastery
Timepoint [2] 446115 0
12 weeks post-randomisation
Secondary outcome [3] 446116 0
change in Breathlessness Mastery
Timepoint [3] 446116 0
24 weeks post-randomisation
Secondary outcome [4] 446117 0
change in Quality of Life
Timepoint [4] 446117 0
4 weeks post-randomisation
Secondary outcome [5] 446118 0
change in Quality of Life
Timepoint [5] 446118 0
8 weeks post-randomisation
Secondary outcome [6] 446119 0
change in Quality of Life
Timepoint [6] 446119 0
12 weeks post-randomisation
Secondary outcome [7] 446120 0
change in Quality of Life
Timepoint [7] 446120 0
24 weeks post-randomisation
Secondary outcome [8] 446121 0
change in Quality of Life
Timepoint [8] 446121 0
4 weeks post-randomisation
Secondary outcome [9] 446124 0
change in Quality of Life
Timepoint [9] 446124 0
8 weeks post-randomisation
Secondary outcome [10] 446125 0
change in Quality of Life
Timepoint [10] 446125 0
12 weeks post-randomisation
Secondary outcome [11] 446126 0
change in Quality of Life
Timepoint [11] 446126 0
24 weeks post-randomisation
Secondary outcome [12] 446127 0
change in distress due to breathlessness
Timepoint [12] 446127 0
4 weeks post-randomisation
Secondary outcome [13] 446130 0
change in distress due to breathlessness
Timepoint [13] 446130 0
8 weeks post-randomisation
Secondary outcome [14] 446131 0
change in distress due to breathlessness
Timepoint [14] 446131 0
12 weeks post-randomisation
Secondary outcome [15] 446132 0
change in distress due to breathlessness
Timepoint [15] 446132 0
24 weeks post-randomisation
Secondary outcome [16] 446133 0
change in worst breathlessness severity in last 24 hours
Timepoint [16] 446133 0
4 weeks post-randomisation
Secondary outcome [17] 446134 0
change in worst breathlessness severity in last 24 hours
Timepoint [17] 446134 0
8 weeks post-randomisation
Secondary outcome [18] 446135 0
change in worst breathlessness severity in last 24 hours
Timepoint [18] 446135 0
12 weeks post-randomisation
Secondary outcome [19] 446136 0
change in worst breathlessness severity in last 24 hours
Timepoint [19] 446136 0
24 weeks post-randomisation
Secondary outcome [20] 446137 0
change in symptoms of anxiety
Timepoint [20] 446137 0
4 weeks post-randomisation
Secondary outcome [21] 446138 0
change in symptoms of anxiety
Timepoint [21] 446138 0
8 weeks post-randomisation
Secondary outcome [22] 446139 0
change in symptoms of anxiety
Timepoint [22] 446139 0
12 weeks post-randomisation
Secondary outcome [23] 446142 0
change in symptoms of anxiety
Timepoint [23] 446142 0
24 weeks post-randomisation
Secondary outcome [24] 446143 0
change in symptoms of depression
Timepoint [24] 446143 0
4 weeks post-randomisation
Secondary outcome [25] 446144 0
change in symptoms of depression
Timepoint [25] 446144 0
8 weeks post-randomisation
Secondary outcome [26] 446145 0
change in symptoms of depression
Timepoint [26] 446145 0
12 weeks post-randomisation
Secondary outcome [27] 446146 0
change in symptoms of depression
Timepoint [27] 446146 0
24 weeks post-randomisation
Secondary outcome [28] 446153 0
change in fatigue
Timepoint [28] 446153 0
4 weeks post-randomisation
Secondary outcome [29] 446154 0
change in fatigue
Timepoint [29] 446154 0
8 weeks post-randomisation
Secondary outcome [30] 446155 0
change in fatigue
Timepoint [30] 446155 0
12 weeks post-randomisation
Secondary outcome [31] 446156 0
change in fatigue
Timepoint [31] 446156 0
24 weeks post-randomisation
Secondary outcome [32] 446157 0
change in health services utilisation
Timepoint [32] 446157 0
24 weeks post-randomisation
Secondary outcome [33] 446158 0
Process evaluation of the Primary Breathe Australia intervention
Timepoint [33] 446158 0
1, 3, and 15 months post-site onboarding

Eligibility
Key inclusion criteria
Each participant must meet the following criteria to be enrolled in this trial:
• Have a clinician-confirmed diagnosis of at least one of the following chronic respiratory diseases (CRD):
o Chronic obstructive pulmonary disease (COPD)
o Interstitial lung disease (ILD)
o Chronic asthma
o Bronchiectasis
o Lung cancer
• Experienced moderate to severe breathlessness (equivalent to 2 or more on mMRC) for 3 months or more
• Aged greater than or equal to 18 years
• Expected survival of greater than or equal to 3 months at time of recruitment (as determined by community clinicians e.g., local GP)
• Is listed as an active patient in the EMR at the recruiting primary care practice (defined as =1 visit in previous 12 months and/or self-report as main primary care practitioner) OR
is a residential client of the recruiting residential aged care facility
• CRD is optimally managed as defined by clinician judgement (for primary care recruited participants)
• Willing and able to complete study assessments and provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not meeting all of the inclusion criteria or meeting any of the following criteria will be excluded from the trial:
• Significant cognitive impairment which prevents the participant from actively engaging with non-pharmacological breathlessness self-management strategies as indicated by a score of 0-3 on the General Practitioner's Assessment of Cognition (GPCOG)
• Unable to understand or comply with a self-management intervention for breathlessness
• Exacerbation of CRD within the past 4 weeks
• Changes to respiratory medications or treatments (including supplemental oxygen therapy) within the past 4 weeks
• Commencement or change of opioids or psychotropic medications within the past 4 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using a randomisation module embedded in an online database (REDCap) hosted on servers at Monash University.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated 1:1 to intervention or control, stratified by study site. The allocation sequence will be computer generated to ensure allocation concealment, sequentially within each stratum (site), using permuted blocks of random sizes to ensure the number of individuals is balanced between study arms within each stratum.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics such as counts, proportions, means and standard deviations (or median and Interquartile range (IQR) if the data distribution is skewed), will be used to summarise and compare participant characteristics by study arm, and present any other relevant data (e.g., characteristics of study sites).
Primary analysis will use, a linear mixed effects model using restricted maximum likelihood will be used to perform a constrained longitudinal data analysis (cLDA) to estimate the between arm difference in mean change in CRQ mastery at each follow up time point (namely, 4-, 8- (primary outcome), and -16 weeks post randomisation) from baseline. The response variable will consist of all CRQ mastery scores at each time point (baseline, 4, 8, 16- and 24week). The model will include study arm, time (baseline, 4, 8, 12- and 24 weeks), and site as fixed effects, and a random effects model for individuals to account for the correlation between repeated measures on the same individual. The model will adjust for CRQ mastery at baseline, where the estimates for the mean CRQ mastery at baseline will be constrained to be equal between the two study arms. The variance-covariance structure for the repeated measures will be defined as unstructured, with alternative structures considered if the model fails to converge. The estimated intervention effect will be reported as the difference in means between the intervention and control arms at each 4, 8, 12 and 24 weeks with 95% confidence interval and p-value. Similar regression analyses appropriate for the data type will be utilised for the secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
246
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318711 0
Government body
Name [1] 318711 0
Australian NHMRC MRFF grant 2022/MRF2022148
Country [1] 318711 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321141 0
None
Name [1] 321141 0
Address [1] 321141 0
Country [1] 321141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317316 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317316 0
Ethics committee country [1] 317316 0
Australia
Date submitted for ethics approval [1] 317316 0
14/04/2025
Approval date [1] 317316 0
20/06/2025
Ethics approval number [1] 317316 0
MUHREC 47110

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

Contacts
Principal investigator
Name 140674 0
Prof Natasha Smallwood
Address 140674 0
Monash University, 99 Commerical Rd, Prahran, VIC 3004
Country 140674 0
Australia
Phone 140674 0
+61 03 99038930
Fax 140674 0
Email 140674 0
[email protected]
Contact person for public queries
Name 140675 0
Amy Pascoe
Address 140675 0
Monash University, 99 Commerical Rd, Prahran, VIC 3004
Country 140675 0
Australia
Phone 140675 0
+61 03 99038930
Fax 140675 0
Email 140675 0
[email protected]
Contact person for scientific queries
Name 140676 0
Natasha Smallwood
Address 140676 0
Monash University 99 Commerical Rd, Prahran, VIC 3004
Country 140676 0
Australia
Phone 140676 0
+61 03 99038930
Fax 140676 0
Email 140676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: pending publication of results, requests to be directed to corresponding author (email address as provided in the publication author details and may vary across publications associated with this study).

Are there extra considerations when requesting access to individual participant data?
No


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.