Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000306819
Ethics application status
Approved
Date submitted
13/10/2020
Date registered
19/03/2021
Date last updated
22/03/2022
Date data sharing statement initially provided
19/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Augmented reality for asthma education in children and adolescents with asthma - a qualitative study
Scientific title
Investigating facilitators and barriers to implementation of an augmented reality delivery mechanism for education and behavioural change in children and adolescents with asthma
Secondary ID [1] 302502 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 319363 0
Condition category
Condition code
Respiratory 317319 317319 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Via an external company and with input from health professionals, we will develop a smartphone and tablet application which can deliver asthma education and behavioural change tools via augmented reality (AR) which is the intervention being investigated.
AR delivered via a smartphone or tablet application can superimpose digital information so that content seems to coexist within the real world, through delivering information through videos, graphs and animation.

This application will function via pattern recognition of a paper-based poster, to trigger educational videos to activate, and initiate the paper-based poster to come to life on either the smartphone or tablet. The educational videos will cover indications for use of different asthma inhalers as well as correct technique of asthma inhalers. We will use current resources such as the Lung Foundation Australia ‘Stepwise Management of Stable COPD’ reference guide which uses similar technology, to underpin our intervention development.

Participants will be recruitedd from three categories – children and adolescents with asthma (aged 8-17), parents/guardians of asthmatic children and adolescents, and health professionals who have treated asthma patients regularly for >12 months in the last 5 years.

Individual participants will be shown a demonstration of how to use the same AR tool by one of the research investigators face to face, then be invited to also trial the use of it themselves.

Qualitative data will be obtained through a once off semi-structured interview of approximately 45-60 minute duration per participant. During this time period, the participant will be shown a demonstration of how to use the AR smartphone/tablet application, then invited to trial the AR tool themselves. The AR tool will be trialled by the participant as a one-off during this time for a period of approximately 10-15 minutes. They will then be asked a range of questions about their opinions of the tool. Once the interview is complete, the participation in the study is complete.

Demonstration and trial of the intervention, and interviews will be conducted at the Women's and Children's Hospital in Adelaide, South Australia. Interviews will be conducted by the principal investigator and co-investigators of the study.

We will use the data obtained to amend the alpha version and create an optimal functional tool for a feasibility study. The aim in this study is to identify barriers and facilitators of the AR tool in this qualitative study and not to assess the effectiveness of the tool itself.
Intervention code [1] 318801 0
Behaviour
Intervention code [2] 318802 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325385 0
Identification of facilitators and barriers of the augmented reality tool delivered via a smartphone or tablet application, for asthma education and behavioural change in children and adolescents.

Measured by one-on-one interviews conducted with semi-structured moderator guides. Interviews will be audio recorded. Participants may be contacted at a later date to validate the content if needed. Analysis will be coded using the theoretical domains framework and analysed using NVivo software.
Timepoint [1] 325385 0
At the time of the interview
Secondary outcome [1] 391960 0
N/A - qualitative study
Timepoint [1] 391960 0
N/A

Eligibility
Key inclusion criteria
Asthma community
Inclusion criteria: Children and adolescents with a clinical diagnosis of asthma or a parent/guardian of an asthmatic child or adolescent

Health professionals who have worked in their profession in South Australia (nursing staff, paediatric general medicine doctors, general practitioners, respiratory specialists, pharmacists and asthma educators) and have treated asthma patients regularly for >12 months in the last 5 years.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to consent
Non-english speaking

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
There are no formal criteria for determining sample size in qualitative research. However, it is suggested that a common range of participants is between 8-15. This is indicative of an adequate size to achieve richness of data and small enough to undertake in-depth, meaningful analysis. We will aim to recruit a total sample size of approximately 17 participants, allowing documentation of diversity and understanding variation among participants.

Qualitative data will be transcribed by an automatic transcription service and coded by two researchers to improve inter-rater reliability. Deductive thematic analysis will be used as the coding method to categorise responses into the 18 domains of the Theoretical Domains Framework. These will be entered and analysed in NViVo software version 11.0.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/04/2021
Actual
26/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306943 0
University
Name [1] 306943 0
The University of Adelaide
Country [1] 306943 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide, North Terrace
SA 5005
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 307502 0
None
Name [1] 307502 0
Address [1] 307502 0
Country [1] 307502 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307077 0
Women's and Children's Health Network: Human Research Ethics Committee
Ethics committee address [1] 307077 0
Ethics committee country [1] 307077 0
Australia
Date submitted for ethics approval [1] 307077 0
Approval date [1] 307077 0
21/08/2020
Ethics approval number [1] 307077 0
HREC/20/WCHN/74

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

Contacts
Principal investigator
Name 105950 0
Dr Antonia Chan
Address 105950 0
Level 6 Respiratory Department
The Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 105950 0
Australia
Phone 105950 0
+61 402529552
Fax 105950 0
Email 105950 0
[email protected]
Contact person for public queries
Name 105951 0
Antonia Chan
Address 105951 0
Level 6 Respiratory Department
The Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 105951 0
Australia
Phone 105951 0
+61 402529552
Fax 105951 0
Email 105951 0
[email protected]
Contact person for scientific queries
Name 105952 0
Antonia Chan
Address 105952 0
Level 6 Respiratory Department
The Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 105952 0
Australia
Phone 105952 0
+61 402529552
Fax 105952 0
Email 105952 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9408Ethical approval    380723-(Uploaded-11-10-2020-22-21-59)-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
No additional documents have been identified.