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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
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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
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Secondary ID [1]
303558
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury
320906
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Healthcare literacy
320921
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Condition category
Condition code
Public Health
318730
318730
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0
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Other public health
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Injuries and Accidents
319133
319133
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0
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Other injuries and accidents
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Neurological
319135
319135
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0
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Other neurological disorders
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Musculoskeletal
319137
319137
0
0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
319851
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Lifestyle
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Intervention code [2]
320417
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Treatment: Other
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
326677
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Timepoint [1]
326677
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At the commencement of the study
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Secondary outcome [1]
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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.
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Assessment method [1]
392344
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Timepoint [1]
392344
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At the completion of the study
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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.
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Minimum age
14
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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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
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/05/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
16
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
307981
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Charities/Societies/Foundations
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Name [1]
307981
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Spinecare Foundation
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Address [1]
307981
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1 Fennell Street, North Parramatta, NSW, 2151
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Country [1]
307981
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Australia
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Primary sponsor type
Individual
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Name
Emily Bray
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Address
Western Sydney University, Locked bag 1797, Penrith, NSW, 2751
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Country
Australia
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Secondary sponsor category [1]
308701
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Individual
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Name [1]
308701
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Lucie Ramjan
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Address [1]
308701
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Western Sydney University, Locked bag 1797, Penrith, NSW, 2751
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Country [1]
308701
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307972
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Western Sydney University Human Research Ethics Committee
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Ethics committee address [1]
307972
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Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751
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Ethics committee country [1]
307972
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Australia
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Date submitted for ethics approval [1]
307972
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Approval date [1]
307972
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19/10/2020
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Ethics approval number [1]
307972
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H14029
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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.
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Trial website
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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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Mrs Emily Bray
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Address
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Western Sydney University, School of Nursing and Midwifery, Building EB/LG, Parramatta South Campus, Locked Bag 1797, Penrith, NSW, 2751
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Country
109098
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Australia
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Phone
109098
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+61 0416269500
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Fax
109098
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Email
109098
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[email protected]
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Contact person for public queries
Name
109099
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Mrs Emily Bray
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Address
109099
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Western Sydney University, School of Nursing and Midwifery, Building EB/LG, Parramatta South Campus, Locked Bag 1797, Penrith, NSW, 2751
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Country
109099
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Australia
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Phone
109099
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+61 0416269500
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Fax
109099
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Email
109099
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[email protected]
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Contact person for scientific queries
Name
109100
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Mrs Emily Bray
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Address
109100
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Western Sydney University, School of Nursing and Midwifery, Building EB/LG, Parramatta South Campus, Locked Bag 1797, Penrith, NSW, 2751
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Country
109100
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Australia
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Phone
109100
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+61 0416269500
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Fax
109100
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Email
109100
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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
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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
Source
Title
Year of Publication
DOI
Embase
Transitioning between paediatric and adult healthcare services: A qualitative study of the experiences of young people with spinal cord injuries and parents/caregivers.
2022
https://dx.doi.org/10.1136/bmjopen-2022-065718
N.B. These documents automatically identified may not have been verified by the study sponsor.
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