ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Respiratory

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]

Not applicable

Comparator / control treatment

No control group (qualitative study)

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

One-off focus group

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

7/05/2019

Actual

7/05/2019

Date of last participant enrolment

Anticipated

28/06/2019

Actual

19/08/2019

Date of last data collection

Anticipated

Actual

19/08/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Medical Research Institute of New Zealand

Address [1]

Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
New Town
Wellington
6021

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Research for Life

Address [2]

Research For Life
(Wellington Medical Research Foundation Inc.)
PO Box 14186
Kilbirnie
Wellington 6241

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and disability and ethics committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/03/2019

Approval date [1]

15/04/2019

Ethics approval number [1]

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

Dr James Fingleton

Address

Medical Research Institute of New Zealand
Private bag 7902
Wellington
6242

Country

New Zealand

Phone

+64 4 805 0234

Fax

[email protected]

Contact person for public queries

Name

Christina Baggott

Address

Medical Research Institute of New Zealand
Private bag 7902
Wellington
6242

Country

New Zealand

Phone

+64 4 805 0262

Fax

[email protected]

Contact person for scientific queries

Name

Christina Baggott

Address

Medical Research Institute of New Zealand
Private bag 7902
Wellington
6242

Country

New Zealand

Phone

+64 4 805 0262

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Attachment
1882	Ethical approval	377253-(Uploaded-15-04-2019-12-41-35)-Study-related document.pdf
1883	Study protocol	377253-(Uploaded-15-04-2019-12-42-20)-Study-related document.doc
1884	Informed consent form	377253-(Uploaded-15-04-2019-12-42-36)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Patient preferences for asthma management: a qualitative study.	2020	https://dx.doi.org/10.1136/bmjopen-2020-037491

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically