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Trial registered on ANZCTR


Registration number
ACTRN12619000601134
Ethics application status
Approved
Date submitted
15/04/2019
Date registered
18/04/2019
Date last updated
5/11/2019
Date data sharing statement initially provided
18/04/2019
Date results information initially provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preferences for Asthma Treatment Regimens – A Qualitative Study.
Scientific title
Preferences for Asthma Treatment Regimens – A Qualitative Study.
Secondary ID [1] 297786 0
MRINZ/19/03
Universal Trial Number (UTN)
UTN: U1111-1229-5743
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 312136 0
Condition category
Condition code
Respiratory 310690 310690 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an exploratory qualitative study on patient preferences for asthma treatment regimens. A serise of focus groups will be ran in patients with asthma, each participant will only attend one focus group. The focus groups will be facilitated by a memember of study staff who has experience in qualitative methodology. They will introduce the topic, guide the discussion and ask questions. The discussion will be semi structured and follow the focus group interview guide. An addition member of staff will take notes. Each group will be audio recorded. Each focus group will last approximately a hour. Audio recordings will be transcribed verbatim. We will analysis the transcripts using content thematic analysis.
Intervention code [1] 315978 0
Not applicable
Comparator / control treatment
No control group (qualitative study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319537 0
Thematic analysis of the characteristics of a "perfect" asthma treatment regimen might be. We will do this using transcripts from focus groups, content and thematic analysis will be undertaken using recognised qualitative methodology.
Timepoint [1] 319537 0
One-off focus group
Secondary outcome [1] 368613 0
Thematic analysis of participants experiences of having asthma. We will do this using transcripts from focus groups, content and thematic analysis will be undertaken using recognised qualitative methodology.
Timepoint [1] 368613 0
One-off focus group

Eligibility
Key inclusion criteria
Adults aged 18-75 with a self-reported doctor diagnosis of asthma who have a current prescription for one or more inhaled asthma medications and have used any inhalers in the last month.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who are not able to or unwilling to give informed consent, who are not fluent in English, who have other pre-existing respiratory diagnoses in addition to asthma, or who are using step 4/5 add-on maintenance treatments for asthma such as oral prednisone, long-acting muscarinic antagonists (LAMAs) or biological agents.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
We will use maximal variation purposeful sampling to recruit approximately 30 people with asthma from the greater Wellington region in New Zealand. As this is a qualitative study there are no formal sample size calculations. We will aim for data that has depth from the focus groups and will stop when we have thematic saturation. The focus groups will be semi structured. The Necessities and Concerns Framework (NCF) which explains treatment beliefs about medicines, as proposed by Horne et al., will be used to guide design of the interview guide which includes questions and prompts. We will use qualitative description as our methodology and content or thematic analysis as our theoretical framework to analyse the data. Initial coding (open-coding) will be done on a line-by-line basis. There will be an iterative process of reading, reviewing and refining themes and subthemes. While the emphasis will be on description to stay true to the participants’ accounts the data will be synthesised into overarching concepts. The process will be adaptive building on new insights emerging from the focus groups.
We will use the following strategies to improve the credibility and trustworthiness of the analysis:
1. Negative case analysis – to find examples where elements of the data contradict the emerging patterns.
2. Peer coding within the research team: increasing richness of concepts being considered; to test whether the ideas emerging from the analysis do in fact arise from the data rather than being imposed on it.
3. Discussion of emerging ideas within the team during initial analysis.
It is anticipated we will have thematic saturation by the end of the 4th focus group, but we will run a final focus group after thematic saturation has been reached to confirm this.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21365 0
New Zealand
State/province [1] 21365 0
Wellington

Funding & Sponsors
Funding source category [1] 302309 0
Charities/Societies/Foundations
Name [1] 302309 0
Medical Research Institute of New Zealand
Address [1] 302309 0
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
New Town
Wellington
6021
Country [1] 302309 0
New Zealand
Funding source category [2] 302615 0
Charities/Societies/Foundations
Name [2] 302615 0
Research for Life
Address [2] 302615 0
Research For Life
(Wellington Medical Research Foundation Inc.)
PO Box 14186
Kilbirnie
Wellington 6241
Country [2] 302615 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
New Town
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 302188 0
None
Name [1] 302188 0
Address [1] 302188 0
Country [1] 302188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302984 0
Health and disability and ethics committee
Ethics committee address [1] 302984 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302984 0
New Zealand
Date submitted for ethics approval [1] 302984 0
26/03/2019
Approval date [1] 302984 0
15/04/2019
Ethics approval number [1] 302984 0
19/CEN/52

Summary
Brief summary
Background:
Patient preferences for specific inhaler regimens and the associated risks and benefits of that regimen are paramount to making informed prescribing choices. Qualitative studies on what patient’s with asthma want from an asthma inhaler regimen are the starting point for understanding asthma treatment from the patient’s perspective, and what their treatment priorities are. Data from qualitative studies on patient preferences for asthma treatment should be incorporated into design of future RCTs into emerging novel inhaler regimens, but in addition should be used to inform how we use existing treatments.


Study Aims
We aim to identify and understand which aspects of asthma inhaler regimens are most important to people with asthma using qualitative methodologies.

Methods:
Design: A series of focus groups in patients with mild to moderate asthma will be used to identify and understand what attributes of asthma treatment regimens are the most important to patients and how they might influence their behaviour.
Participants: approximately 30 participants with mild to moderate asthma will be recruited from advertising and purposive sampling will be used to achieve a mix of ages, gender, ethnic backgrounds and asthma treatment experience.
Study procedures: a focus group topic guide will be used to aid the discussion. The theoretical basis used to inform the focus group topic guide is that of self-regulation and self-management. The main topics covered will be the concept of a “perfect” asthma treatment regimen and patients experiences of having asthma.
Data analysis: the focus groups will be audio recorded then transcribed verbatim. We will use content thematic analysis to analyse our data.

Significance:
This will allow better understanding of the factors influencing patient decisions and which asthma regimens they have a preference for. It will also be used to influence future studies regarding patient preferences for asthma treatment regimens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92070 0
Dr James Fingleton
Address 92070 0
Medical Research Institute of New Zealand
Private bag 7902
Wellington
6242
Country 92070 0
New Zealand
Phone 92070 0
+64 4 805 0234
Fax 92070 0
Email 92070 0
james.fingleton@mrinz.ac.nz
Contact person for public queries
Name 92071 0
Dr Christina Baggott
Address 92071 0
Medical Research Institute of New Zealand
Private bag 7902
Wellington
6242
Country 92071 0
New Zealand
Phone 92071 0
+64 4 805 0262
Fax 92071 0
Email 92071 0
christina.baggott@mrinz.ac.nz
Contact person for scientific queries
Name 92072 0
Dr Christina Baggott
Address 92072 0
Medical Research Institute of New Zealand
Private bag 7902
Wellington
6242
Country 92072 0
New Zealand
Phone 92072 0
+64 4 805 0262
Fax 92072 0
Email 92072 0
christina.baggott@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a qualitative study, the data is coming from focus groups so providing individual participant data is not appropriate.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1882 0
Ethical approval
Citation [1] 1882 0
Link [1] 1882 0
Email [1] 1882 0
Other [1] 1882 0
Type [2] 1883 0
Study protocol
Citation [2] 1883 0
Link [2] 1883 0
Email [2] 1883 0
Other [2] 1883 0
Type [3] 1884 0
Informed consent form
Citation [3] 1884 0
Link [3] 1884 0
Email [3] 1884 0
Other [3] 1884 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary