UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060070 |
|---|---|
| Receipt number | R000067783 |
| Scientific Title | Effectiveness Evaluation Study of the Chiyoda City Tripartite Joint Project, Participatory Art - A Program for Living Well with Dementia |
| Date of disclosure of the study information | 2025/12/13 |
| Last modified on | 2025/12/12 15:52:28 |
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Basic information
Public title
Effectiveness Evaluation Study of a Participatory Art Program for Living Well with Dementia
Acronym
Participatory Art Effectiveness Evaluation Study
Scientific Title
Effectiveness Evaluation Study of the Chiyoda City Tripartite Joint Project, Participatory Art - A Program for Living Well with Dementia
Scientific Title:Acronym
Participatory Art for Living Well with Dementia - Chiyoda Evaluation Study
Region
| Japan |
Condition
Condition
Dementia, Mild Cognitive Impairment (MCI), Healthy Older Adults
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of a participatory, inclusive art program, in which people with and without dementia can jointly participate, on mental health through a randomized controlled trial (RCT).
Basic objectives2
Others
Basic objectives -Others
In addition to mental well-being, to clarify the effects on stigma reduction toward dementia, cognitive function, physical function, and social participation, and, as a secondary aim, to promote regional implementation as part of community-based dementia support initiatives and to disseminate the program through collaboration among participating institutions.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is mental well-being, assessed using the Japanese version of the WHO-Five Well-Being Index (WHO-5-J).
Key secondary outcomes
1.Mental health
UCLA Loneliness Scale
Rosenberg Self-Esteem Scale
General Self-Efficacy Scale
EQ-5D-5L
Depressive state Two-Question Screening
2.Social indicators
Frequency of interpersonal interactions
Frequency of going out
Social isolation LSNS-6
Engagement in social leisure activities and use of day services
3. Cognitive function
MMSE-J
Trail Making Test A and B
4. Physical function
Grip strength
Pinch strength
Blood pressure
Instrumental Activities of Daily Living
5. Oral function
OF-5
Salivary amylase
6. Mood assessment
Profile of Mood States POMS
Visual Analogue Scale for mood and impressions
7. Behavioral observation
Observation and recording of participants behaviors during each session
8. Narrative interviews
Effects of the participatory art program
Ease of participation
Perceptions of dementia
Negative reactions
9. Program satisfaction
Evaluation of satisfaction through feedback after each session
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: A participatory clinical art program designed to be accessible for people with dementia, combined with peer meetings for persons with dementia. Group sessions will be conducted for 120 minutes per session, 6 sessions over approximately 3 months.
Interventions/Control_2
Control group: Health education (attention control). Lectures on general health topics delivered by healthcare professionals. Frequency and duration matched to the intervention group.
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals with dementia, mild cognitive impairment (MCI), or subjective memory concerns, residing in the community (including those living outside Chiyoda City but receiving care at medical institutions within the ward).
2.Ability to provide written informed consent for participation in this study.
Key exclusion criteria
1.Individuals currently undergoing acute treatment for psychiatric or physical illness
2.In the case of persons with dementia, when family members do not consent to their participation
3.Individuals deemed inappropriate for inclusion in this study by the principal investigator, for example due to the severity of dementia symptoms making participation in the program difficult
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Sugiyama |
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
+81339643241
sugiyama@tmig.or.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Sugiyama |
Organization
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
+81339643241
Homepage URL
sugiyama@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department
Personal name
Mika Sugiyama
Funding Source
Organization
Chiyoda-ku, Tokyo
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
Tel
+81339643241
sugiyama@tmig.or.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 | 12 | Month | 13 | 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
55
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067783
