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Trial registered on ANZCTR
Registration number
ACTRN12622000627752
Ethics application status
Approved
Date submitted
6/04/2022
Date registered
28/04/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
28/04/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Interactive SNAP (Smoking/Nutrition/Alcohol/Physical Activity) program for adolescents delivered with Augmented Reality technology: A Qualitative Study
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Scientific title
Interactive SNAP program for adolescents delivered with Augmented Reality technology: A Qualitative Study
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Secondary ID [1]
306725
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NHMRC – Grant Number GNT1141521
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Universal Trial Number (UTN)
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Trial acronym
N/A
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Smoking
325705
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Poor nutrition
325706
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Excessive alcohol consumption
325707
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Physical Inactivity
325708
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Condition category
Condition code
Public Health
323053
323053
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This novel AR intervention will be demonstrated via a recorded video of the primary investigator accessing the AR poster via Zappar. The participants will not use the AR intervention themselves as part of our study. The content covered during the demonstration will be purely how to access the educational content. Video will normally be displayed via Zoom call, but in the case of an audio only interview, a link to an online video of the demonstration will be provided.
A preliminary questionnaire will be available to complete prior to interviews. Preliminary interview is expected to take 20 minutes, 25 minutes if questionnaire completion required, demonstration is expected to take less than 5 minutes, followed by a post test interview of approximately 30 minutes, including verbally running through the follow up questionnaire.
All interviews will be conducted remotely, either via Zoom call or telephone.
All interviews will be conducted by the primary investigator.
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Intervention code [1]
323326
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Prevention
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Determining overall participant acceptance of the AR educational resources, assessed using the Theoretical Framework of Acceptability via one-on-one semi structured interviews delivered via Zoom video or telephone call
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Assessment method [1]
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Timepoint [1]
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Immediately after AR demonstration video
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Secondary outcome [1]
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Using the System Usability Scale to measure the participants view regarding the usability of our intervention
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Assessment method [1]
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Timepoint [1]
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Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.
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Secondary outcome [2]
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Assessing an adolescents opinion on the acceptability of AR health education resources for adolescents using one-on-one semi structured interviews delivered via Zoom video or telephone call.
Areas to be assessed include all areas of Theoretical framework of Acceptability, including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.
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Assessment method [2]
408798
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Timepoint [2]
408798
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Adolescent interviews only
Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.
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Secondary outcome [3]
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Assessing a parents opinion on the acceptability of AR health education resources for adolescents using one-on-one semi structured interviews delivered via Zoom video or telephone call.
Areas to be assessed include all areas of Theoretical framework of Acceptability, including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.
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Assessment method [3]
408799
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Timepoint [3]
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Parent interviews only
Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.
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Secondary outcome [4]
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Assessing a health professionals opinion on the acceptability of AR health education resources for adolescents using one-on-one semi structured interviews delivered via Zoom video or telephone call.
Areas to be assessed include all areas of Theoretical framework of Acceptability, including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.
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Assessment method [4]
408800
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Timepoint [4]
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Health professional interviews only
Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.
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Eligibility
Key inclusion criteria
1) Adolescents aged 13-18 years old
Adolescents must be between the ages of 13-18 years of age when the interviews are performed and have a parent or caregiver willing to provide written consent.
2) Parents of adolescents aged 13-18 years old
Parents/caregivers must have at least one child in the age range of 13-18 years of age when interviews are performed,
3) Health professionals (doctors, nurses and allied health professionals)
Health professionals must have been practising in their field at least 12 months.
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Minimum age
13
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
All participants much be able to communicate comfortably in both written and verbal English and have no intellectual or cognitive impairment that would limit their ability to give informed consent.
Adolescents must be between the ages of 13-18 years of age when the interviews are performed and have a parent or caregiver willing to provide written consent.
Parents/caregivers must have at least one child in the age range of 13-18 years of age when interviews are performed, see time period above.
Health professionals must have been practising in their field at least 12 months, see time period above.
While not an exclusion criteria; If a participant is known to a member of the investigator team, another member of the team will complete the interviews and analysis process, so that any confidential personal information is not available for any known individuals.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
N/A
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Kim, Sefcik and Bradway (2017) indicated smaller sample sizes (11-20) were suitable for Qualitative Descriptive research, especially when the primary data collection tool are interviews. When Hennink, Kaiser and Marconi (2017) analysed transcripts of semi-structured interviews, researchers found that 91% of the codes were identified by the sixth interview.
Transcripts developed from processing audio recordings will be coded using the Theoretical Framework of Acceptability/Theoretical Domains Framework and the System Usability Scale. Coding will occur by two independent researchers, using NViVo software, with results reported through narrative synthesis. Quantitative data will be pooled together for means, standard deviations and ranges. Qualitative data will be coded to organize the texts into themes, to help the researchers to identify barriers or enablers for this intervention.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
7/05/2022
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Actual
7/05/2022
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Date of last participant enrolment
Anticipated
28/02/2023
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Actual
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Date of last data collection
Anticipated
31/03/2023
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Actual
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Sample size
Target
21
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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South Australian Health and Medical Research Institute (SAHMRI) - Adelaide
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Recruitment hospital [2]
22147
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UniSA Health and Medical Clinic (City West) - Adelaide
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Recruitment postcode(s) [1]
37269
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 260
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Country [1]
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Australia
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Primary sponsor type
University
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Name
UniSA City East
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Address
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
312385
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Country [1]
312385
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Other collaborator category [1]
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Other
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Name [1]
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South Australian Health and Medical Research Institute (SAHMRI)
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Address [1]
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North Terrace, Adelaide SA 5000
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310601
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UniSA's Human Research Ethics Committee (HREC)
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Ethics committee address [1]
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UniSA Human Research Ethics Committee
Research and Innovation Services
GP Building
Mawson Lakes Boulevard,
Mawson Lakes
South Australia 5095
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Ethics committee country [1]
310601
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Australia
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Date submitted for ethics approval [1]
310601
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02/02/2022
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Approval date [1]
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16/02/2022
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Ethics approval number [1]
310601
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Application ID: 204093
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Summary
Brief summary
Study Purpose: to understand the general publics opinion of delivering health information using augmented reality, and any factors that improve/reduce its perceived effectiveness.
Description: we will demonstrate health education delivered via an app called Zappar, which works with an AR poster we developed with adolescents. Our study involves interviews designed to understand peoples opinions on digital education, including our intervention in particular, and learn the perceived strengths and weaknesses of our intervention.
Study Hypothesis: Education via AR interventions are an acceptable alternative to adolescents
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Trial website
https://www.unisa.edu.au/research/research-volunteers/interactive-snap-program-for-adolescents-delivered-with-augmented-reality-technology
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr John Niwa
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Address
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South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide SA 5000
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Country
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Australia
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Phone
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+61 414979335
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Fax
118222
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Email
118222
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[email protected]
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Contact person for public queries
Name
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Mr John Niwa
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Address
118223
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South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide SA 5000
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Country
118223
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Australia
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Phone
118223
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+61 8 8128 4000
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Fax
118223
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Query!
Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Kristin Chahhoud
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Address
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South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide SA 5000
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Country
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Australia
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Phone
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+61 412 708 879
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Fax
118224
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Email
118224
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Analysis of anonymized data will be the only information available publicly.
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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.
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