Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001455550
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
BREATHE SMART- Breathlessness Rapid Evaluation And THErapy- Screening, Management
And IntegRated Technology: Screening adults in Australian GP clinics
Scientific title
BREATHE SMART- Breathlessness Rapid Evaluation And THErapy- Screening, Management
And IntegRated Technology: Uptake of the self-screening for dyspnoea using the BREATHE SMART tool in adults attending GP clinics
Secondary ID [1] 313305 0
None
Universal Trial Number (UTN)
Trial acronym
BREATHE SMART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dyspnoea 335648 0
breathlessness 335649 0
Condition category
Condition code
Respiratory 332202 332202 0 0
Other respiratory disorders / diseases
Respiratory 332203 332203 0 0
Asthma
Respiratory 332204 332204 0 0
Chronic obstructive pulmonary disease
Public Health 332205 332205 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BREATHE study consists of two components: BREATHE SMART (Breathlessness Rapid Evaluation And THErapy- Screening, Management And IntegRated Technology) and BREATHE CDSS (Breathlessness Rapid Evaluation And THErapy- Clinical Decision Support System). The details of the BREATHE CDSS study is registered seperately.

The primary objective of BREATHE SMART is to develop a fully integrated system of patient self-screening for dyspnea in general practice.

In the BREATHE SMART study we are working with Better Consult software, a product of HealthShare. BetterConsult is a pre-consultation tool that captures patients’ presenting symptoms, medications and other relevant clinical information and then translates the data into concise medical notes for review. Better Consult integrates with Best Practice, a leading primary care practice management software. Better Consult reads the practice electronic appointment book at the beginning of each day and sends an automated SMS prior to their scheduled GP appointment with a link to a specific self-screening survey.

Each in scope patient (i.e. >= 18 years of age with a booked appointment with a GP) will be consented though the BetterConsult digital interface and initially asked to rate if they have any difficulty with breathing using the validated mMRC scale. If they rate this answer as “0” (no dyspnea) then they will not progress any further. For all other patients, dyspnea will be further assessed using the Dyspnea-12 (D-12) score- a questionnaire that quantifies physical/affective aspects of dyspnea and queried about the length of time they have been experiencing breathlessness. The screening procedure will take 5-10 minutes to complete, and patients will be invited to participate at each GP appointment they attend through the study period.

These screening results will be imported to the patient’s electronic medical record. When the GP opens the patient's electronic medical record the GP will be prompted to review these results and can discuss this with the patient during their appointment or at a subsequent visit. Further investigations and management will be at the GP's discretion. GPs will be trained in use of the CDSS and in interpretation of the various scales. GP usage of the CDSS will be able to be tracked by the performance metrics of the software.

The patient self-screening intervention will run for 12 months in each practice.
Intervention code [1] 329878 0
Early detection / Screening
Comparator / control treatment
A before/after comparator will be used to compare the case detection of of a number of chronic dyspnea-related conditions (e.g. asthma, chronic obstructive pulmonary disease, heart failure) made in the 12 months prior to the intervention and the 12 months of the intervention.

A data extraction will be obtained retrospectively for all practices for the twelve months prior to the commencement of the self-screen intervention which will provide ‘baseline/preintervention’ data, and this will be compared to the 12 months of the intervention.
Control group
Historical

Outcomes
Primary outcome [1] 339788 0
Proportion of patients undertaking self screening for dyspnea
Timepoint [1] 339788 0
The 12 months that the intervention is active in the practice.
Primary outcome [2] 339789 0
Proportion of patients with chronic dyspnea
Timepoint [2] 339789 0
The 12 months that the intervention is active in the practice.
Secondary outcome [1] 441331 0
Number of newly-diagnosed cases of asthma) per 1000 patients over the study period
Timepoint [1] 441331 0
- 12 months of the self-screening intervention.
Secondary outcome [2] 442375 0
Number of newly-diagnosed cases of COPD per 1000 patients over the study period
Timepoint [2] 442375 0
- 12 months of the self-screening intervention.
Secondary outcome [3] 442376 0
Number of newly-diagnosed cases of lung cancer per 1000 patients over the study period
Timepoint [3] 442376 0
- 12 months of the self-screening intervention.
Secondary outcome [4] 442377 0
Number of newly-diagnosed cases of heart failure per 1000 patients over the study period
Timepoint [4] 442377 0
- 12 months of the self-screening intervention.

Eligibility
Key inclusion criteria
Patients booked for a GP consultation (either face-to-face or telehealth), greater than (or equal to) 18 years that have consented to SMS communication with their GP practice.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age and/or have not consented to SMS communication wither their GP practice.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This BREATHE SMART study is part of a cluster randomised controlled study (BREATHE) where clusters are randomised to arm 1 (BREATHE SMART - registered in this form) or arm 2 (BREATHE CDSS - registered separately). This arm (BREATHE SMART) is a before/after study assessing the impact of the BREATHE SMART tool.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A data extraction will be obtained retrospectively for all practices for the twelve months prior to the commencement of the self-screen intervention which will provide ‘baseline/preintervention’ data. Basic demographic data will be collected to compare the two cohorts to assess for disparities. This will be done by a data extraction software.

Descriptive analyses will occur both at the individual practice level, and for all practices pooled together.

Analyses of pre-intervention data

• Total number of in-scope patients actively attending the practice;

• Total number of patients newly identified with dyspnea and a range of conditions related to dyspnea (e.g., asthma, COPD, heart failure) in the pre-intervention period;

• The rate of detection (per 1000 patients) of dyspnea and dyspnea-related conditions;

Analyses of intervention data

• Total number of in-scope patients actively attending the practice over the study period;

• Total number of in-scope patients completing dyspnea self-screening;

• Total number of patients identified with dyspnea requiring further investigation;

• The rate of detection of dyspnea requiring further investigation (per 1000 patients);

• The rate of detection of newly-detected conditions related to dyspnea (per 1000 patients) (e.g. asthma, COPD, heart failure);

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
12000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS

Funding & Sponsors
Funding source category [1] 317753 0
Government body
Name [1] 317753 0
Medical Research Future Fund (MRFF), Department of Health and Aged Care
Country [1] 317753 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
Country
Australia
Secondary sponsor category [1] 320072 0
None
Name [1] 320072 0
Address [1] 320072 0
Country [1] 320072 0
Other collaborator category [1] 283277 0
Other
Name [1] 283277 0
The George Institute
Address [1] 283277 0
Country [1] 283277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316440 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 316440 0
Ethics committee country [1] 316440 0
Australia
Date submitted for ethics approval [1] 316440 0
22/05/2024
Approval date [1] 316440 0
02/10/2024
Ethics approval number [1] 316440 0
iRECS6645

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

Contacts
Principal investigator
Name 137906 0
Prof Charlotte Hespe
Address 137906 0
The University of Notre Dame 160 Oxford St Darlinghurst NSW 2010
Country 137906 0
Australia
Phone 137906 0
+61414855322
Fax 137906 0
Email 137906 0
charlotte.hespe@nd.edu.au
Contact person for public queries
Name 137907 0
Charlotte Hespe
Address 137907 0
The University of Notre Dame 160 Oxford St Darlinghurst NSW 2010
Country 137907 0
Australia
Phone 137907 0
+61414855322
Fax 137907 0
Email 137907 0
charlotte.hespe@nd.edu.au
Contact person for scientific queries
Name 137908 0
A/Prof Katrina Giskes
Address 137908 0
The University of Notre Dame 160 Oxford St Darlinghurst NSW 2010
Country 137908 0
Australia
Phone 137908 0
+61414441847
Fax 137908 0
Email 137908 0
katrina.giskes@nd.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24310Study protocol  katrina.giskes@nd.edu.au
24311Ethical approval  katrina.giskes@nd.edu.au



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.