Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001562460
Ethics application status
Approved
Date submitted
31/08/2016
Date registered
11/11/2016
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
People's experiences of severe asthma
Scientific title
Investigating people's personal experiences of living with and managing severe asthma: a qualitative study
Secondary ID [1] 289919 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Asthma 299890 0
Condition category
Condition code
Respiratory 299793 299793 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an exploratory, qualitative study, investigating the personal experiences of people living with severe asthma. Interviews will be performed on a one-off basis. This will involve a video and audio recorded interview that will be conducted in their own home. Each interview would go for approximately 1-2 hours.
Using rigorous, systematic qualitative methods we will analyse transcripts from in-depth individual interviews, and use these data to publish in peer reviewed international journals. Also, part of our study will include developing a visual web-based information resource for use by the public (information and support) and health professionals (education/training). We are following the DIPEx methodology, that has been used for thousands of participants in the UK, several other countries, and has been used for six studies within Australia so far (on www.healthtalkaustralia.org).
Intervention code [1] 295603 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299257 0
Using transcripts from the interviews, a content and thematic analysis will be undertaken using standard qualitative methods.
Timepoint [1] 299257 0
One-off interview session
Secondary outcome [1] 326659 0
Our first secondary outcome is developing a web-based resource, for the Australian version of the website www.healthtalkonline.org as well as the website for the Centre for Research Excellence in Severe Asthma (CRESA). The CRESA website is yet to be developed.
Timepoint [1] 326659 0
Following completion of all participant interviews and qualitative analysis
Secondary outcome [2] 327600 0
Our second secondary outcome is Identifying goals important to people with severe asthma using the transcripts from in-depth interviews
Timepoint [2] 327600 0
during one off interview sessions

Eligibility
Key inclusion criteria
Participants will be included if they are over 18 years old and must be diagnosed with severe asthma. Severe asthma is defined as asthma for which control can be maintained only with the highest level of recommended treatment or good control is not achieved despite the highest level of recommended treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they don't have a confirmed diagnosis of severe asthma.

Study design
Purpose of the study
Educational / counselling / training
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 design features
Phase
Type of endpoint/s
Statistical methods / analysis
In line with standard qualitative research practice we will use a maximum variation sampling framework, which is a purposive sample of approximately 30-50 people with severe refractory asthma, who will be recruited from different settings across Australia. Therefore, no formal sample calculations were performed. We aim for depth in our interviews and we will keep interviewing participants until no new themes have emerged.The methods used for this project are based on those established by the Health Experiences Research Group (HERG) at the University of Oxford and managed through the DIPEx UK Charity. We will use systematic and rigorous qualitative research methods and analysis, using a narrative illness methodology and thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/11/2016
Actual
Date of last participant enrolment
Anticipated
29/09/2017
Actual
Date of last data collection
Anticipated
30/11/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294285 0
Other Collaborative groups
Name [1] 294285 0
Centre of Research Excellence in Severe Asthma
Country [1] 294285 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Lorraine Smith,University of Sydney
Address
Faculty of Pharmacy
A15 - Pharmacy And Bank Building
The University of Sydney
2006
Country
Australia
Secondary sponsor category [1] 293122 0
Individual
Name [1] 293122 0
Associate Professor. Helen Reddel
Address [1] 293122 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW Sydney, Australia
2037
Country [1] 293122 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295717 0
Human Research Ethics Committee
Ethics committee address [1] 295717 0
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 295717 0
Australia
Date submitted for ethics approval [1] 295717 0
03/12/2015
Approval date [1] 295717 0
17/02/2016
Ethics approval number [1] 295717 0
2015/934

Summary
Brief summary
Background:
Asthma is a common chronic lung disease and symptoms vary from mild to severe. Within the general population with asthma, approximately 5-10% suffer with severe asthma. People with severe asthma run the highest risk for acute and/or severe exacerbations and mortality, yet there is not much empirical data on how this affects the patients lived experience.

Aim:
Using the Database of Personal Experiences of Health and Illness (DIPEx) methodology we aim to explore the personal experiences of people living with severe asthma.

Methods:
Participants will be included if they are over 18 years old and must be diagnosed with severe asthma. A maximum variation sample of approximately 30-50 participants will be recruited from different settings across Australia. DIPEx methodology involves audio and/or video recording potential participants and encourages them to talk without interruption about all aspects of their experiences that mattered to them. The collected data will be transcribed and coded into ‘categories’ and ‘themes’. These categories and themes will be based on areas that are identified as important to the participants.

Significance:
These stories will be used as a reliable source of information to educate students and health care professionals, and as an evidence base to inform person-centered care and future policy improvements to understand the concerns, meaning and priorities of a diverse range of people with severe asthma. The topic summaries, and selected video clips, will also be published on the website http://healthtalkaustralia.org
Trial website
http://healthtalkaustralia.org.
http://www.severeasthma.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68210 0
A/Prof Lorraine Smith
Address 68210 0
Pharmacy and Bank Building A15
The University of Sydney
NSW
2066
Country 68210 0
Australia
Phone 68210 0
+61 2 9036 7079
Fax 68210 0
Email 68210 0
[email protected]
Contact person for public queries
Name 68211 0
Daniela Eassey
Address 68211 0
N372 Pharmacy and Bank Building A15
The University of Sydney
NSW
2006
Country 68211 0
Australia
Phone 68211 0
+61293516471
Fax 68211 0
Email 68211 0
[email protected]
Contact person for scientific queries
Name 68212 0
Daniela Eassey
Address 68212 0
N372 Pharmacy and Bank Building A15
The University of Sydney
NSW
2006
Country 68212 0
Australia
Phone 68212 0
+61293516471
Fax 68212 0
Email 68212 0
[email protected]

No information has been provided regarding IPD availability


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.