Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001223921
Ethics application status
Approved
Date submitted
7/08/2020
Date registered
16/11/2020
Date last updated
21/12/2021
Date data sharing statement initially provided
16/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kick the Smokes: Augmented Reality resources to provide smoking cessation information for Aboriginal South Australian tobacco users, and to provide culturally-tailored smoking cessation advice to health professionals.
Scientific title
Development and evaluation of evidence-based augmented reality resources to provide smoking cessation advice for Aboriginal South Australian tobacco users and training in culturally-tailored smoking cessation for health professionals - Qualitative
Secondary ID [1] 301969 0
GNT1108309
Universal Trial Number (UTN)
U1111-1256-5799
Trial acronym
KTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation 318530 0
Condition category
Condition code
Public Health 316534 316534 0 0
Health promotion/education
Public Health 316535 316535 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "Development and evaluation of evidence-based augmented reality resources to provide smoking cessation advice for Aboriginal South Australian tobacco users and training in culturally-tailored smoking cessation for health professionals - Qualitative" is a health promotion project.
Aboriginal Australians are over-represented in the lower socioeconomic status index and tobacco use is a leading risk factor for development of cancer, premature mortality and chronic diseases. Educational information delivered via Augmented Reality (AR) has the potential to address issues of poor health literacy by using digital video, audio and graphical content to explain medical terms and techniques.
This project will develop a workbook, and resource package as physical resources for the delivery of educational material to Aboriginal smokers and health professionals respectively. Both resources can be viewed using a smart-phone app that triggers complimentary AR content as virtual resources. Both physical and virtual resources will deliver educational material unique to their respective cohort. A co-design process will be separately undertaken with each cohort to ensure that resources are culturally appropriate and fit for purpose.
During 'yarning circles' of Aboriginal smokers and ex-smokers will have the opportunity to review the workbook and its associated AR content. Although subject to co-design, the workbook will likely feature information on mindfulness, the physical effects of smoking, information on prescription medications (Champix and Zyban) and Nicotine Replacement Therapies (Patches, Lozenges, Gum and Mouth spray) as well as worksheets (e.g.: ‘How to beat cravings’) and other activities (e.g.: drawing). The AR content will overlay certain images within the workbook and provide educational content in the form of light-hearted (funny/engaging/motivating/empowering) facts and content individuals can view to help with distraction during cravings. The AR is accessed when a workbook image is scanned with a smartphone running the 'Kick the Smokes' app, thereby triggering linked virtual content (noting content audio will be in English or Pitjantjatjara).
In the 1-on-1 interviews, health professionals will have the opportunity to review the resource package and its associated AR-enabled videos. This package will provide professional education on smoking cessation that will likely draw on the existing ‘Very Brief Advice on Smoking’ program. Information from this program will inform the physical and virtual elements of this resource package.
Yarning circle participants and health professionals will be presented with versions of both the workbook, package and the app (respectively) and asked to provide their feedback during their session. Each session is designed to introduce participants to the resources and to obtain their thoughts on their aesthetic, functionality and content. There is no requirement for participants, from either cohort, to use the resources either prior to or after their session.
A total of 42 Aboriginal smokers will be enrolled, this cohort will be comprised of the following groups:
Female smokers (18-35 yrs) n=7
Male smokers (18-35 yrs) n=7
Female smokers (35+ yrs) n=7
Male smokers (35+ yrs) n=7
Female ex-smokers (18+ yrs) n=7
Male ex-smokers (18+ yrs) n=7
Each yarning circle participant is only required to attend one session, and it is anticipated that each session will run for approximately two and a half hours.
A total of 16 health professionals will be enrolled, this cohort will be comprised of the following groups:
Specialist medical officers n=4
Nurses n=4
Allied health professionals n=4
Trainee medical officers, advanced trainees, registrars n=4
Each health professional is only required to attend one interview, and it is anticipated that each interview will run for approximately one hour.
Experienced research staff will run the yarning circles and the 1-on-1 interviews; both forums will be run in a semi-structured interview manner using a pre-defined moderator guide. Each guide contains a series of questions and has been developed in reference to its audience and the projects co-design aims. Where possible the yarning circles and 1-on-1 interviews will be held in person and within metropolitan Adelaide (South Australia). Due to the potential restriction for community engagement, a contingency has been included within the study design to enable the 1-on-1 interviews and yarning circles to be held via teleconferencing.
It is anticipated that the focus group and 1-on-1 interviews will run between August 2020 and March 2021.
Qualitative data obtained during the yarning circles and interviews will be examined using deductive thematic analysis. The purpose of this examination is to understand the barriers and facilitators faced by both Aboriginal smokers and health professionals. Using the ‘Theoretical Framework of Acceptability ’ (TFA) and the 'Theoretical Domains Framework' (TDF) researchers will identify the perceptions of each cohort towards the technology, and how these relate to the use of the resources in their personal and professional lives.
Intervention code [1] 318257 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324662 0
Change in Aboriginal South Australian smoker attitude towards the resource as measured through deductive thematic analysis of yarning circle response data.
Timepoint [1] 324662 0
3 months after data collection period ceases (i.e.; 30 June 2021).
Primary outcome [2] 324663 0
Change in South Australian Health Professional attitude towards the resource as measured through deductive thematic analysis of interview response data.
Timepoint [2] 324663 0
3 months after data collection period ceases (i.e.; 30 June 2021).
Secondary outcome [1] 386797 0
Understanding of the barriers and facilitators for use of augmented reality delivered resources by Aboriginal smokers and health professionals in South Australia as determined through a deductive thematic analysis of participant response data (yarning circle and interview respectively).
Timepoint [1] 386797 0
3 months after data collection period ceases (i.e.; 30 June 2021).

Eligibility
Key inclusion criteria
Aboriginal smokers:
• Self-identifies as Aboriginal
• Lives in South Australia
• Able to provide written informed consent
• >=18 years of age
• Fluent English speaker
• Current smoker or ex-smoker

Health professionals:
• Current or recent (within the past two years) practicing health professional within South Australia
• Able to provide written informed consent
• >=18 years of age
• Worked regularly over the previous 12 months with Aboriginal South Australians
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aboriginal smokers:
• Not a current/past resident of South Australia
• Neurological/ cognitive impairment impeding consent
• Unable to provide written informed consent
• Unable to communicate proficiently in English
• Severe mental health disorder limiting ability to provide informed consent

Health professionals:
• Not a current or recent resident of South Australia
• Neurological/ cognitive impairment impeding consent
• Unable to provide written informed consent
• Unable to communicate proficiently in English

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants within the "Aboriginal smokers" cohort receive the same intervention; and,
all participants within the "health professionals" cohort receive the same intervention. The interventions of each cohort are mutually exclusive; therefore, the outcomes of each cohort will not be compared.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The co-design process will use a deductive thematic analysis approach. Data collected through yarning circles and interviews will be transcribed and examined using qualitative analysis software. The purpose of this analysis is to identify respondent themes that will enable the refinement of the physical and AR resources.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/08/2020
Date of last participant enrolment
Anticipated
29/03/2021
Actual
16/07/2021
Date of last data collection
Anticipated
31/03/2021
Actual
16/07/2021
Sample size
Target
58
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17201 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 17202 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 17203 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 30909 0
5000 - Adelaide
Recruitment postcode(s) [2] 30910 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 30911 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 306392 0
Government body
Name [1] 306392 0
National Health and Medical Research Council
Country [1] 306392 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
101 Currie St,
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 306899 0
None
Name [1] 306899 0
Address [1] 306899 0
Country [1] 306899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306591 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 306591 0
Ethics committee country [1] 306591 0
Australia
Date submitted for ethics approval [1] 306591 0
22/10/2019
Approval date [1] 306591 0
06/04/2020
Ethics approval number [1] 306591 0
04-19-851
Ethics committee name [2] 306596 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 306596 0
Ethics committee country [2] 306596 0
Australia
Date submitted for ethics approval [2] 306596 0
29/04/2020
Approval date [2] 306596 0
21/05/2020
Ethics approval number [2] 306596 0
203117

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

Contacts
Principal investigator
Name 104394 0
A/Prof Kristin Carson-Chahhoud
Address 104394 0
University of South Australia
(Translational Medicine and Technology Group)
GPO Box 2471,
Adelaide SA 5001
Country 104394 0
Australia
Phone 104394 0
+61 883020453
Fax 104394 0
Email 104394 0
[email protected]
Contact person for public queries
Name 104395 0
Kristin Carson-Chahhoud
Address 104395 0
University of South Australia
(Translational Medicine and Technology Group)
GPO Box 2471,
Adelaide SA 5001
Country 104395 0
Australia
Phone 104395 0
+61 883020453
Fax 104395 0
Email 104395 0
[email protected]
Contact person for scientific queries
Name 104396 0
Kristin Carson-Chahhoud
Address 104396 0
University of South Australia
(Translational Medicine and Technology Group)
GPO Box 2471,
Adelaide SA 5001
Country 104396 0
Australia
Phone 104396 0
+61 883020453
Fax 104396 0
Email 104396 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
Individual Participant Data will not be shared due to the governance arrangements agreed with the approved ethics document enabling this research.


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.