UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063110 |
|---|---|
| Receipt number | R000072245 |
| Scientific Title | Effects of understanding the perspectives of people with dementia on family caregivers: A study using the "Ninchisho Sekai no Arukikata" workshop |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 02:32:33 |
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Basic information
Public title
Changes in family caregivers' understanding of dementia after the "Ninchisho Sekai no Arukikata" workshop
Acronym
Dementia Workshop Study
Scientific Title
Effects of understanding the perspectives of people with dementia on family caregivers: A study using the "Ninchisho Sekai no Arukikata" workshop
Scientific Title:Acronym
Dementia Perspective Workshop Study
Region
| Japan |
Condition
Condition
Dementia (study participants are family caregivers of people with dementia)
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This exploratory pilot study will examine short-term changes in family caregivers' understanding and perceptions of the subjective experiences and behavioral contexts of people with dementia before and after participation in the "Ninchisho Sekai no Arukikata" experiential workshop. Secondary exploratory objectives are to examine changes in a specific aspect of caregiver burden, including negative feelings and attitudes, and in state anxiety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from immediately before to immediately after the workshop in caregivers' understanding of the perspectives and behavioral contexts of people with dementia and in their perceptions of people with dementia. Six study-specific items are rated on a five-point scale (1-5), assessing the ability to (1) imagine how the person feels, (2) consider the person's perspective, (3) recognize reasons underlying behavior, (4) interpret behavioral and psychological symptoms of dementia as expressions rather than merely problematic behavior, (5) regard the person as an individual living their own life, and (6) consider supportive environments and care approaches. The response distribution and pre-post change for each item will be examined descriptively and exploratorily.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Family caregivers will participate in an approximately 90-minute experiential workshop based on "Ninchisho Sekai no Arukikata." The program comprises a 10-minute introduction, 25 minutes of video-based learning, 35 minutes of group work using 44 cards describing impairments of mental and physical functions, 15 minutes of group discussion, and a 5-minute reflection. It addresses subjective experiences and behavioral contexts of people with dementia and supportive approaches to daily life. Workshops are scheduled on October 31 and December 5, 2026. Participants will complete questionnaires immediately before and after their workshop.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Age 18 years or older at consent; (2) has a family member or close relative diagnosed with dementia; (3) actually provides care for the person with dementia; (4) is able to participate in the workshop; and (5) provides written informed consent.
Key exclusion criteria
(1) Is not a family caregiver of a person with dementia; (2) is unable to participate in the workshop; or (3) is judged unsuitable by the principal investigator or a co-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miyae |
| Middle name | |
| Last name | Yamakawa |
Organization
The University of Osaka
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
5650871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
0668792543
miyatabu@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyae |
| Middle name | |
| Last name | Yamakawa |
Organization
The University of Osaka
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
5650871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
0668792543
Homepage URL
miyatabu@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Miyae Yamakawa
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka
Tel
0668796106
rinri@hp-crc.med.osaka-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 | 09 | Month | 30 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072245
