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Trial registered on ANZCTR


Registration number
ACTRN12620001109998
Ethics application status
Approved
Date submitted
31/08/2020
Date registered
27/10/2020
Date last updated
22/12/2021
Date data sharing statement initially provided
27/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Mixed reality and holographic technologies to deliver cognitive and behavioural therapies for the treatment of symptoms of anxiety among teenagers with asthma
Scientific title
Mixed reality technology as a delivery mechanism for psychological intervention in adolescents with asthma
Secondary ID [1] 302092 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 318855 0
Psychological distress 318856 0
Condition category
Condition code
Respiratory 316858 316858 0 0
Asthma
Mental Health 316859 316859 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a qualitative study, seeking to explore the use of mixed reality technologies (augmented reality (AR), virtual reality (VR), holographics) as a delivery mechanism for cognitive and behavioural therapies (CBT) in the treatment of elevated psychological distress among young people with asthma.

The mixed reality resources are yet to be developed. They will be based on a component of CBT, and will be developed by the investigator team's Clinical Psychologist. A needs review for this study is currently underway, which will be used to inform the development of these resources.

To evaluate perceptions of usability and appropriateness to reach target audience, qualitative research will be carried out through one-on-one interviews. During the interviews, mixed reality tools will be demonstrated and participants allocated time to interact with the resources themselves. Semi-structured moderator guides based on rigorous, systematic frameworks will be used to direct interviews with n= 10 young people, n=10 parents, and n=10 health professionals. Qualitative interviews will be supplemented with a questionnaire including Likert scales to facilitate triangulation of data, and the System Useability Scale to identify useability data.

Interviews will run for approximately one hour, and will take place in meeting spaces in the respiratory departments at two large, teaching hospitals in metropolitan Adelaide, South Australia, or online via Zoom software, according to the participant's preference.
Intervention code [1] 322514 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324967 0
Understanding of the feasibility of mixed reality resources for use by youth (13-17 years) through interviews with young people with asthma.
Timepoint [1] 324967 0
At once-off interviews
Primary outcome [2] 325271 0
Understanding of the feasibility of mixed reality tools for use by youth (13-17 years) through interviews with parents/caregivers of young people with asthma.
Timepoint [2] 325271 0
At once-off interview
Primary outcome [3] 325272 0
Understanding of the feasibility of mixed reality tools for use by youth (13-17 years) through interviews with healthcare professionals.
Timepoint [3] 325272 0
At once-off interview.
Secondary outcome [1] 386376 0
Usability of the mixed reality tools will be assessed using the System Usability Scale
Timepoint [1] 386376 0
At once-off interview.

Eligibility
Key inclusion criteria
Inclusion criteria for young people: Young people will be eligible for inclusion in this study if they: are aged between 13 and 17 years; have been formally diagnosed with asthma by a health professional (inpatients or outpatients); have experienced or are currently experiencing heightened symptoms of psychological distress determined by the K10+ scale; have access to a smartphone with the owner’s permission to use it; are English speaking/able to understand written English.

Inclusion criteria for caregivers/parents: Participants will be eligible for inclusion in this study if they: are the caregiver/parent of a child with asthma (aged 13 to 17 years) who currently has/or has reported in the past heightened symptoms of psychological distress (does not need to be the parent/caregiver of a child actively participating in this study); have access to a smartphone and able to use smartphone technology (basic level); are English speaking/able to understand written English.

Inclusion criteria for health professionals: Health professionals will be eligible for inclusion in this study if they: have been practicing in their respective fields for at least 12-months; have access to a smartphone and are able to use smartphone technology (basic level); are English speaking/able to understand written English.
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with an intellectual disability or cognitive impairment that would inhibit their ability to provide informed consent and participate in the project will be ineligible to participate. Young people with a history of epilepsy or other contraindication for the use of VR will also be ineligible to participate.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Qualitative data will be coded using three pre-specified lenses to enable insight into different aspects of the mixed reality interventions. This includes: the Theroetical Domains Framework to aid knowledge translation potential, the Theoretical Framework of Acceptability to evaluate acceptability of the mixed reality intervention as a method to deliver CBT to young people with asthma, and the Enlight protocol (an evaluation tool for mobile eHealth interventions) to evaluate quality and therapeutic potential for the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/11/2020
Actual
22/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17374 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 17375 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 31103 0
5006 - North Adelaide
Recruitment postcode(s) [2] 31104 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 306511 0
Charities/Societies/Foundations
Name [1] 306511 0
Channel 7 Children's Research Foundation
Country [1] 306511 0
Australia
Funding source category [2] 306608 0
University
Name [2] 306608 0
University of South Australia
Country [2] 306608 0
Australia
Funding source category [3] 306609 0
Government body
Name [3] 306609 0
National Health and Medical Research Council (NHMRC)
Country [3] 306609 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 307039 0
None
Name [1] 307039 0
Address [1] 307039 0
Country [1] 307039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306715 0
Women’s and Children’s Health Network (WCHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 306715 0
Ethics committee country [1] 306715 0
Australia
Date submitted for ethics approval [1] 306715 0
Approval date [1] 306715 0
03/06/2019
Ethics approval number [1] 306715 0
Ethics committee name [2] 306793 0
UniSA Human Research Ethics Committee
Ethics committee address [2] 306793 0
Ethics committee country [2] 306793 0
Australia
Date submitted for ethics approval [2] 306793 0
28/06/2019
Approval date [2] 306793 0
Ethics approval number [2] 306793 0

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

Contacts
Principal investigator
Name 104766 0
A/Prof Kristin Carson-Chahhoud
Address 104766 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 104766 0
Australia
Phone 104766 0
+61 08 8302 0453
Fax 104766 0
Email 104766 0
kristin.carson-chahhoud@unisa.edu.au
Contact person for public queries
Name 104767 0
Kelsey Sharrad
Address 104767 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 104767 0
Australia
Phone 104767 0
+61 08 8302 2734
Fax 104767 0
Email 104767 0
kelsey.sharrad@unisa.edu.au
Contact person for scientific queries
Name 104768 0
Kelsey Sharrad
Address 104768 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 104768 0
Australia
Phone 104768 0
+61 08 8302 2734
Fax 104768 0
Email 104768 0
kelsey.sharrad@unisa.edu.au

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?

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.