Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001036909
Ethics application status
Approved
Date submitted
5/08/2020
Date registered
12/10/2020
Date last updated
10/06/2021
Date data sharing statement initially provided
12/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating patient experiences of obtaining a diagnosis of severe asthma: the Severe Asthma Pathways Study
Scientific title
Investigating patient experiences of obtaining a diagnosis of severe asthma: the Severe Asthma Pathways Study
Secondary ID [1] 301949 0
None
Universal Trial Number (UTN)
Trial acronym
SAP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe asthma 318497 0
Condition category
Condition code
Respiratory 316500 316500 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People with severe asthma will be interviewed about their experiences in obtaining a severe asthma diagnosis. It is anticipated that there will only be a single exposure to the patient but given the nature of qualitative research, follow up exposures may be necessary to further explore interview topics to prevent interview fatigue and in depth exploration of topics. The patient will determine the length of each exposure based on their comfort levels. The anticipated maximum duration of a single interview will be approximately 60 minutes to prevent interview fatigue and further interviews scheduled if necessary. The maximum number of interviews that a participant may be asked to complete to further explore interview topics will be three, e.g. maximum of three 60 minute interviews spaced one month apart.
The participant is not required to complete any questionnaires, either online or in person.

Topics covered in the interviews will include time taken to receive a diagnosis of severe asthma, number of specialists seen, symptoms experienced (onset/duration), interactions with primary health care including pharmacists and general practitioners.

The overall duration of study participation when follow-up interviews are undertaken will be no longer than three months.
Interviews will be conducted, via videoconference to allow for rapport to develop between interviewer and participant. HOWEVER, only audio recordings will be kept.
The interviews will be conducted by a research assistant trained in qualitative interview techniques.
Intervention code [1] 318236 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324644 0
Time taken to receive a final diagnosis of severe asthma as reported by participants during an audio-recorded, semi-structured one-on-one interview.
Timepoint [1] 324644 0
Cumulative participant responses will be assessed at the end of the recruitment period.
Secondary outcome [1] 385321 0
Perceived barriers to achieving severe asthma diagnosis as reported by participants during an audio-recorded, semi-structured one-on-one interview.
Timepoint [1] 385321 0
Cumulative participant responses will be assessed at the end of the recruitment period

Eligibility
Key inclusion criteria
People with severe asthma that are able to speak English comfortably.
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
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
None.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/11/2020
Actual
8/12/2020
Date of last participant enrolment
Anticipated
30/12/2021
Actual
Date of last data collection
Anticipated
30/12/2021
Actual
Sample size
Target
50
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 306365 0
Commercial sector/Industry
Name [1] 306365 0
GSK Pty LTd
Country [1] 306365 0
United Kingdom
Primary sponsor type
Other
Name
The Woolcock Institute of Medical Research
Address
431 Glebe Point Rd Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 306876 0
None
Name [1] 306876 0
Address [1] 306876 0
Country [1] 306876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306572 0
University of Sydney Human Ethics Committee
Ethics committee address [1] 306572 0
Ethics committee country [1] 306572 0
Australia
Date submitted for ethics approval [1] 306572 0
03/08/2020
Approval date [1] 306572 0
14/09/2020
Ethics approval number [1] 306572 0
2020/522

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

Contacts
Principal investigator
Name 104326 0
Prof Sinthia Bosnic-Anticevich
Address 104326 0
The Woolcock Institute of Medical Research
431 Glebe Point Rd Glebe NSW 2037 Australia
Country 104326 0
Australia
Phone 104326 0
+61 2 91140145
Fax 104326 0
Email 104326 0
[email protected]
Contact person for public queries
Name 104327 0
Sinthia Bosnic-Anticevich
Address 104327 0
The Woolcock Institute of Medical Research
431 Glebe Point Rd Glebe NSW 2037 Australia
Country 104327 0
Australia
Phone 104327 0
+61 2 91140145
Fax 104327 0
Email 104327 0
[email protected]
Contact person for scientific queries
Name 104328 0
Sinthia Bosnic-Anticevich
Address 104328 0
The Woolcock Institute of Medical Research
431 Glebe Point Rd Glebe NSW 2037 Australia
Country 104328 0
Australia
Phone 104328 0
+61 2 91140145
Fax 104328 0
Email 104328 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
Consent for sharing has not been applied for in ethics application.


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.