UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058184 |
|---|---|
| Receipt number | R000066517 |
| Scientific Title | Quality of Life in Children with Medical Complexity: a scoping review |
| Date of disclosure of the study information | 2025/06/23 |
| Last modified on | 2025/06/30 11:19:43 |
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Basic information
Public title
Quality of Life in Children with Medical Complexity: a scoping review
Acronym
Quality of Life in Children with Medical Complexity: a scoping review
Scientific Title
Quality of Life in Children with Medical Complexity: a scoping review
Scientific Title:Acronym
Quality of Life in Children with Medical Complexity: a scoping review
Region
| Japan |
Condition
Condition
Children with Medical Complexity
Classification by specialty
| Pediatrics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify how caregivers view QOL in children with medical complexity
Basic objectives2
Others
Basic objectives -Others
To map how caregivers view QOL in children with medical complexity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL in children with medical complexity
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The subjects are caregivers who directly provide daily living care, including medical care.
2) The study describes QOL.
3) The study includes children under 18 years of age who receive chronic complex medical care or multiple medical care needs.
4) The study was written in Japanese or English.
Key exclusion criteria
1) Methodological studies.
2) Review, Grey articles, Books, and Protocol papers.
3) Duplicate articles.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Mikuru |
| Middle name | |
| Last name | Hayashida |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu
TEL
059-232-1111
325m104@m.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Mikuru |
| Middle name | |
| Last name | Hayashida |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu
TEL
059-232-1111
Homepage URL
325m104@m.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University
Address
2-174 Edobashi, Tsu
Tel
059-232-1111
325m104@m.mie-u.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 | 06 | Month | 23 | 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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data sources and search strategy
We will conduct a scoping review to identify how caregivers view QOL in children with medical complexity. This scoping review will be conducted using the electronic databases, PubMed, CINAHL, Medical Journal Web Edition ver. 5, and CiNii, with the keywords "medical complexity," "children," "caregivers," and "QOL" for all literature reported from inception to June 20, 2025.
Selection of studies in included studies
Two review authors will independently check to ensure that studies meet the inclusion criteria. Any discrepancies in study selection will be resolved by discussion or discussion with a third author.
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066517
