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Trial registered on ANZCTR


Registration number
ACTRN12621000500853
Ethics application status
Approved
Date submitted
2/03/2021
Date registered
29/04/2021
Date last updated
29/04/2021
Date data sharing statement initially provided
29/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting the Transition of Children and Young People with a Spinal Cord Injury from Paediatric to Adult Healthcare Services
Scientific title
Determining the Acceptability and Feasibility of a Co-designed Healthcare Transition Intervention for Children and Young People with a Spinal Cord Injury Transitioning from Paediatric to Adult Healthcare Services
Secondary ID [1] 303558 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 320906 0
Healthcare literacy 320921 0
Condition category
Condition code
Public Health 318730 318730 0 0
Other public health
Injuries and Accidents 319133 319133 0 0
Other injuries and accidents
Neurological 319135 319135 0 0
Other neurological disorders
Musculoskeletal 319137 319137 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participatory action research - over the course of a 12–18 month period, young people with a paediatric-onset spinal cord injury and parents of young people with a paediatric-onset spinal cord injury will be asked to
1) Share their experience with the transition from the paediatric to adult healthcare settings. This will include a 60 minute individual interview in which participants will discuss the needs, gaps, weaknesses and opportunities relating to healthcare transition for young people with spinal cord injury.
2) Co-design a healthcare transition support intervention. Once all interviews have been completed, interviewed participants will be invited to collaborate in a 90 minute group co-design workshop; one for young people and one for parents/caregivers. The workshops will have two phases, the first being to analyse the data from the interviews and the second to co-design the healthcare transition support intervention. The first phase of the workshop will require participants to review samples of unidentifiable excerpts of interviews and initial codes/categories generated by the researchers and decide on their authenticity. Once in agreement on codes/categories, working together researchers and participants (co-researchers) will group codes/categories into themes. In the co-design phase young people's healthcare transition needs and recommendations for the development of the healthcare transition support intervention will be explored. The researcher will use the future workshop method to facilitate discussion and generation of ideas for the development of the healthcare transition support intervention and participants will then work together to brainstorm designs. The future workshop method guides participants through three phases: a critique phase, a fantasy phase and an implementation phase. The aim of the critique phase will be to review the themes identified in the data analysis phase to identify deficits or challenges related to healthcare transition experienced by young people with spinal cord injures. In the fantasy phase, the participants will be given creative freedom to generate utopian ideas about the best possible way to mitigate the issues. In the third phase, the participants will transform the utopian ideas into a design for a practical and realisable healthcare transition support intervention.
3) Refine the draft healthcare transition support intervention. The researcher will take the designs developed in the workshop and within 6 months of the workshops completion turn them into a tangible healthcare transition support intervention. Following the development of a draft healthcare transition support intervention, young people with spinal cord injuries and their parents/caregivers from part 1 and 2 will be invited to participate in a 60 minute focus group to provide their feedback, further develop and refine the draft healthcare transition support intervention.
4) Feedback. Within 2 months of the focus groups completion the researcher will refine the healthcare transition support intervention and send the final HCT intervention to participants involved in parts 1, 2 and 3 as well as relevant stakeholders. Participants will be asked to review the healthcare transition support intervention and will be invited to participate in a brief 15 minute individual interview to provide feedback on the acceptability and feasibility of the final healthcare transition support intervention.
Intervention code [1] 319851 0
Lifestyle
Intervention code [2] 320417 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326677 0
Semi-structured one-on-one 60 minute interviews will be used to collect qualitative data on the experience of healthcare transition and transition needs of young people with spinal cord injury from the perspectives of the young people themselves and parents/caregivers. Interviews will be conducted over the telephone or online using video-conferencing software (Zoom) at a time that is convenient to the participant. All interviews will be audio-recorded and transcribed.
Timepoint [1] 326677 0
At the commencement of the study
Secondary outcome [1] 392344 0
Brief one-on-one interviews will be conducted over the telephone or online using video-conferencing software (Zoom) at a time that is convenient to the participant. The interviews are anticipated to take 15 minutes. The interviews will evaluate the feasibility and acceptability of the developed healthcare transition support intervention using open ended questions to explore participants’ satisfaction, opinion on ease of use, whether they would continue using it or recommend it to a friend. All interviews will be audio recorded and transcribed.
Timepoint [1] 392344 0
At the completion of the study

Eligibility
Key inclusion criteria
Young people must be between the ages of 14 and 25 years old, have acquired a paediatric onset spinal cord injury (before the age of 18) and have sufficient English language proficiency to allow for engagement and discussion.

Parents and carers must have a child with a paediatric onset spinal cord injury and have sufficient English language proficiency to allow for engagement and discussion.
Minimum age
14 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The young person must not currently be in hospital receiving rehabilitation treatment for a spinal-cord injury acquired in the last 12 months.

The parent/caregiver must not be looking after a child currently in hospital receiving rehabilitation treatment for a spinal cord injury acquired in the last 12 months.

Study design
Purpose of the study
Prevention
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307981 0
Charities/Societies/Foundations
Name [1] 307981 0
Spinecare Foundation
Country [1] 307981 0
Australia
Primary sponsor type
Individual
Name
Emily Bray
Address
Western Sydney University, Locked bag 1797, Penrith, NSW, 2751
Country
Australia
Secondary sponsor category [1] 308701 0
Individual
Name [1] 308701 0
Lucie Ramjan
Address [1] 308701 0
Western Sydney University, Locked bag 1797, Penrith, NSW, 2751
Country [1] 308701 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307972 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 307972 0
Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751
Ethics committee country [1] 307972 0
Australia
Date submitted for ethics approval [1] 307972 0
Approval date [1] 307972 0
19/10/2020
Ethics approval number [1] 307972 0
H14029

Summary
Brief summary
The purpose of this study is to develop healthcare transition support resources and tools for young people with spinal cord injuries (SCI). The specific objectives will be to:
• Understand the experience of healthcare transition for young people with SCI and their parents/caregivers.
• Explore the current healthcare transition needs of young people with SCI.
• Co-design and develop healthcare transition support resources and tools for young people with SCI.
• Evaluate the acceptability and feasibility of the healthcare transition support resources and tools in supporting the transition process.
The project will adopt a participatory action research approach to its investigation and invite young people (age 14- 25) with a paediatric onset SCI and parents/caregivers of children with a paediatric onset SCI to participate at all stages of the project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109098 0
Mrs Emily Bray
Address 109098 0
Western Sydney University, School of Nursing and Midwifery, Building EB/LG, Parramatta South Campus, Locked Bag 1797, Penrith, NSW, 2751
Country 109098 0
Australia
Phone 109098 0
+61 0416269500
Fax 109098 0
Email 109098 0
[email protected]
Contact person for public queries
Name 109099 0
Emily Bray
Address 109099 0
Western Sydney University, School of Nursing and Midwifery, Building EB/LG, Parramatta South Campus, Locked Bag 1797, Penrith, NSW, 2751
Country 109099 0
Australia
Phone 109099 0
+61 0416269500
Fax 109099 0
Email 109099 0
[email protected]
Contact person for scientific queries
Name 109100 0
Emily Bray
Address 109100 0
Western Sydney University, School of Nursing and Midwifery, Building EB/LG, Parramatta South Campus, Locked Bag 1797, Penrith, NSW, 2751
Country 109100 0
Australia
Phone 109100 0
+61 0416269500
Fax 109100 0
Email 109100 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?

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
SourceTitleYear of PublicationDOI
EmbaseTransitioning between paediatric and adult healthcare services: A qualitative study of the experiences of young people with spinal cord injuries and parents/caregivers.2022https://dx.doi.org/10.1136/bmjopen-2022-065718
N.B. These documents automatically identified may not have been verified by the study sponsor.