UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061716 |
|---|---|
| Receipt number | R000070631 |
| Scientific Title | Discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease: a scoping review |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/28 14:15:06 |
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Basic information
Public title
Discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease: a scoping review
Acronym
Discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease: a scoping review
Scientific Title
Discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease: a scoping review
Scientific Title:Acronym
Discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease: a scoping review
Region
| Japan |
Condition
Condition
Congenital heart disease
Classification by specialty
| Cardiology | Pediatrics | Cardiovascular surgery |
| Nursing | Not applicable | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify what studies have been conducted on discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease.
Basic objectives2
Others
Basic objectives -Others
To map the study populations, age groups, diseases, clinical settings, contents of discussions, study designs, and perspectives of existing studies, and to identify gaps in the literature.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Characteristics of existing studies on discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease.
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Studies involving patients aged 6 years or older with congenital heart disease, or studies involving their family members or healthcare professionals.
2. Studies in which discussions related to palliative care or end-of-life care are the main focus.
These discussions include advance care planning (ACP), end-of-life discussions, goals-of-care discussions, prognostic discussions, DNR/DNAR, treatment limitation, withholding or withdrawal of life-sustaining treatment, and discussions about place of care or end-of-life care.
3. Primary research, including qualitative studies, quantitative studies, mixed-methods studies, cross-sectional studies, observational studies, interview studies, and questionnaire surveys.
5.Studies published in English or Japanese.
Key exclusion criteria
1. Duplicate publications.
2. Conference abstracts or proceedings only.
3. Review articles, guidelines, statements, expert opinions, editorials, or comments.
4.Studies involving only patients with general heart disease that first developed in adulthood.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Fujisawa |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu
TEL
08024149458
326m108@m.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Fujisawa |
Organization
Mie University
Division name
Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu
TEL
080-2414-9458
Homepage URL
326m108@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
08024149458
326m108@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
| 2026 | Year | 06 | Month | 01 | 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
| 2026 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 27 | 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 what studies have been conducted on discussions about palliative and end-of-life care for school-aged and older patients with congenital heart disease. We will search electronic databases including PubMed, CINAHL, and Ichushi-Web. Search terms will include congenital heart disease, Fontan, Glenn, palliative care, end-of-life care, advance care planning, goals of care, discussion, communication, and decision making. Controlled vocabulary and free-text terms will be combined according to each database. The search period will be from database inception to the date of the search.
Selection of studies:
Two reviewers will independently screen titles and abstracts according to the inclusion and exclusion criteria, and then assess full-text articles to determine eligibility. Disagreements will be resolved through discussion, and, if necessary, by consultation with a third reviewer.
Data extraction:
We will extract information on study populations, age groups, diseases, clinical settings, contents of discussions about palliative and end-of-life care, study designs, perspectives, main findings, and gaps in the literature.
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070631
