Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000252112
Ethics application status
Approved
Date submitted
28/01/2019
Date registered
20/02/2019
Date last updated
15/02/2021
Date data sharing statement initially provided
20/02/2019
Date results provided
15/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Immersive Reality Experiences(IRE)for Improving the Wellbeing of Young People in Hospital
Scientific title
Evaluation of Immersive Reality Experiences(IRE)for Improving the Wellbeing of Young People in Hospital
Secondary ID [1] 297227 0
Nil
Universal Trial Number (UTN)
U1111-1227-5157
Trial acronym
IRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
long-term physical conditions e.g. asthma, cancer, diabetes 311289 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309902 309902 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immersive Reality Experience (IRE) technology will be used to connect hospitalised children with their school or home environments to minimise social isolation. The technology includes a VR headset at Starship Children's Hospital in Auckland and a camera at the distal location (home or school) delivered and managed by a research assistant. Participants will be recruited via their treating teams. Following the completion of consent procedures and pre-intervention measures, participants will have continuous access to IRE technology for a 6-week period, at the end of which they will complete post-intervention outcome measures and follow-up interviews.

Participants will use VR headsets and the camera to see and hear their counterparts at school or home. No direct verbal communication with them will be possible as there is no microphone at the hospital end of the connection (a limitation of the current device's design). There will not be any restriction on use of devices or headsets by participants - this will be entirely up to participants (dose of use can be recorded via the device, but will not be limited). From the previous phase of this research, we know that young people usually use them from between a few minutes to an hour at a time.
Intervention code [1] 313480 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318847 0
Change in wellbeing as measured using the Warwick Edinburgh Wellbeing Scale (WEWBS)
Timepoint [1] 318847 0
6 weeks post intervention commencement
Primary outcome [2] 318848 0
Change in social connectedness as measured using the Social Connectedness Scale (SCS),
Timepoint [2] 318848 0
6 weeks post intervention commencement
Primary outcome [3] 318849 0
Change in social inclusion as measured using the Social Inclusion Scale (SCOPE)
Timepoint [3] 318849 0
6 weeks post intervention commencement
Secondary outcome [1] 367038 0
Qualitative experience of children's use of IRE assessed via individual interviews - 30-60 mins each, audiotaped, questions including the following:

Possible interview questions for young person (language adapted for younger children)
Decision about participation
• What sparked your interest in taking part in the project?
• Have you told anyone about the project and what did you tell them? What was their reaction?
Use of technology
• How easy or difficult have you found it to use the equipment? Could you tell us a little more about that?
• How would you suggest we improve the experience of using the technology in the future?
Experience
• Can you tell me what is was like being in an IR session?
Prompts: How many sessions did you have with your chosen environment? How long were the sessions? Did you prefer one of the sessions over the others? Could you tell us a little more about that? How long did you spend in each session?
• What was it like for you to experience your environment through the help of the technologies?
Prompts: Were you able to learn something (if a school environment)? Were you able to effectively communicate with anyone in the environment during this experience? Could you tell me a little more about this? Was there anyone in particular that you interacted with more during the sessions?
• What would you suggest to make the experience better?
Prompts: What would you say about the experience to another young person going through your experience?
• On reflection, how did your feelings about IRE technology change before and after the experience?
Timepoint [1] 367038 0
6 weeks post intervention commencement
Secondary outcome [2] 367083 0
Qualitative experience of parent's use/support of IRE assessed via individual interviews - 30-60 mins each, audiotaped, questions including the following:

Possible interview questions for family members and/or caregivers and school staff / support person in nominated environment
Decision about participation
• What sparked your interest in supporting (young person) to take part in the project?
• Have you told anyone about the project and what did you tell them? What was their reaction?
• Is there anything that you were concerned about?

Use of technology
• How easy or difficult has (young person) found it to use the equipment? Could you tell us a little more about that?
• How would you suggest we improve the experience of using the technology for other young people in the future?
• Do you think it might be limiting in any way? Could you tell us a little more about that?

Experience
• Can you tell me what is was like to see (young person) in an IR session?
Prompts: Was there an appreciable difference in the dynamics of the environment when (young person) either positive or negative, while (young person) was participating? Did you have to make any changes to accommodate the session?
• What was your experience of seeing (young person) access an environment through the help of the technologies?
Prompts: Were everyone able to effectively communicate with one another in the environment during this experience? Could you tell me a little more about this? Was there anyone in particular that (young person) interacted with more during the sessions?
• What would you suggest to make the experience better?
Prompts: What would you say about the experience to another caregivers or support persons going through the experience?
• On reflection, how did your feelings about IRE technology change before and after the experience?
• How would you describe your and other’s experience of (young person)’s session? Would you be keen to undertake further sessions if asked?
Timepoint [2] 367083 0
6 weeks post intervention commencement

Eligibility
Key inclusion criteria
Children and young people with any medical condition, aged between 13-18 years and admitted to Starship Hospital for more than a 2-week period or intermittently over a longer period will be eligible to participate in the study.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those under 13 years of age, those with a physical or mental health issue that prevents exposure to IRE technology, and those not able to provide informed consent (or assent with parental consent) will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will include basic descriptive statistics. Qualitative data regarding participants’ and their family’s or school staff’s views related to social inclusion, social connectedness and wellbeing will be gathered post-intervention (at 6 weeks) via semi-structured interviews. Participants’ experience with the intervention, including acceptability and usefulness of the technology, will also be sought at this time. Data will be audiotaped, transcribed and analysed using of thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/08/2019
Date of last participant enrolment
Anticipated
31/10/2019
Actual
1/12/2020
Date of last data collection
Anticipated
13/12/2019
Actual
1/01/2021
Sample size
Target
60
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 21227 0
New Zealand
State/province [1] 21227 0
Auckland

Funding & Sponsors
Funding source category [1] 301774 0
Charities/Societies/Foundations
Name [1] 301774 0
Starship Foundation
Country [1] 301774 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Level 12 Support Block, Auckland Hospital, 2 Park Road, Grafton, Auckland 1142, New Zealand.
Country
New Zealand
Secondary sponsor category [1] 301519 0
None
Name [1] 301519 0
Address [1] 301519 0
Country [1] 301519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302491 0
HDEC approval received from the Northern A committee
Ethics committee address [1] 302491 0
Ethics committee country [1] 302491 0
New Zealand
Date submitted for ethics approval [1] 302491 0
31/01/2019
Approval date [1] 302491 0
21/06/2019
Ethics approval number [1] 302491 0
19NTA43

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

Contacts
Principal investigator
Name 90406 0
Dr Hiran Thabrew
Address 90406 0
Department of Psychological Medicine, Level 12 Support Block, Auckland Hospital, 2 Park Road, Grafton, Auckland 1142
Country 90406 0
New Zealand
Phone 90406 0
+64 21402055
Fax 90406 0
Email 90406 0
[email protected]
Contact person for public queries
Name 90407 0
Hiran Thabrew
Address 90407 0
Department of Psychological Medicine, Level 12 Support Block, Auckland Hospital, 2 Park Road, Grafton, Auckland 1142
Country 90407 0
New Zealand
Phone 90407 0
+64 21402055
Fax 90407 0
Email 90407 0
[email protected]
Contact person for scientific queries
Name 90408 0
Hiran Thabrew
Address 90408 0
Department of Psychological Medicine, Level 12 Support Block, Auckland Hospital, 2 Park Road, Grafton, Auckland 1142
Country 90408 0
New Zealand
Phone 90408 0
+64 21402055
Fax 90408 0
Email 90408 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
1182Study protocol    376837-(Uploaded-28-01-2019-20-03-54)-Study-related document.docx



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.