UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058540 |
|---|---|
| Receipt number | R000066616 |
| Scientific Title | A Study on the educational use of a simulation-based card game on pediatric-to-adult healthcare transition for individuals with childhood-onset neurologic conditions: A multi-perspective study involving patients, families, supporters, and healthcare professionals |
| Date of disclosure of the study information | 2025/08/24 |
| Last modified on | 2025/07/22 02:13:02 |
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Basic information
Public title
A Study on the educational use of a simulation-based card game on pediatric-to-adult healthcare transition for individuals with childhood-onset neurologic conditions: A multi-perspective study involving patients, families, supporters, and healthcare professionals
Acronym
A Study on the educational use of a simulation-based card game on pediatric-to-adult healthcare transition for individuals with childhood-onset neurologic conditions: A multi-perspective study involving patients, families, supporters, and healthcare professionals
Scientific Title
A Study on the educational use of a simulation-based card game on pediatric-to-adult healthcare transition for individuals with childhood-onset neurologic conditions: A multi-perspective study involving patients, families, supporters, and healthcare professionals
Scientific Title:Acronym
A Study on the educational use of a simulation-based card game on pediatric-to-adult healthcare transition for individuals with childhood-onset neurologic conditions: A multi-perspective study involving patients, families, supporters, and healthcare professionals
Region
| Japan |
Condition
Condition
Childhood-onset neurologic conditions, Spina bifida
Classification by specialty
| Neurology | Pediatrics | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the educational effectiveness of the Japanese version of the 'Young Heroes Team', a simulation-based tool developed by the applicant to facilitate understanding of the transition from pediatric to adult care in individuals with childhood-onset neurological disorders, targeting patients and their families, support providers (such as special education teachers and welfare professionals), as well as medical students and junior doctors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In children with childhood-onset neurologic conditions, resilience will be evaluated using a child resilience scale after the first game session, after the second session, and six weeks following the second session. For parents and support providers of these children, resilience will be assessed using an adult resilience scale immediately after the game and six weeks later. For healthcare professionals, awareness regarding transitional care will be evaluated after completion of the game.
Key secondary outcomes
In children with childhood-onset neurologic conditions, quality of life QOL will be assessed and health-related QOL, after the first game session, after the second session, and six weeks following the second session. For parents and support providers, anxiety levels and awareness of transitional care will be evaluated after the game and again six weeks later.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I. Children with childhood-onset neurologic conditions, including spina bifida
II. Parents and support providers of children with childhood-onset neurologic conditions
III. Healthcare professionals
Key exclusion criteria
Those who are unable to independently participate in the game and respond to the questionnaire, or who are otherwise judged by the principal investigator to be unsuitable for participation.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Kinya |
| Middle name | |
| Last name | Ishikawa |
Organization
Institute of Science Tokyo
Division name
Graduate School of Medical and Dental Sciences, Personalized Genomic Medicine for Health
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo^ku, Tokyo
TEL
03-5803-4728
osako.miho@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Osako |
Organization
Institute of Science Tokyo
Division name
Graduate School of Medical and Dental Sciences, Personalized Genomic Medicine for Health
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4728
Homepage URL
osako.miho@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Sasakawa Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional observational study involving patients with childhood-onset neurological disorders (such as spina bifida), their caregivers/supporters, and healthcare professionals. Using an educational card-based tool, the study investigates awareness and understanding related to healthcare transition from pediatric to adult care. Written informed consent and, when applicable, assent will be obtained from all participants.
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066616
