UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057821 |
|---|---|
| Receipt number | R000066091 |
| Scientific Title | Effectiveness of Reminiscence Therapy Using Large Screens Optimized for the Visual Needs of People with Dementia |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/05/09 19:00:46 |
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Basic information
Public title
Effectiveness of Reminiscence Therapy Using Large Screens Optimized for the Visual Needs of People with Dementia
Acronym
Effectiveness of Reminiscence Therapy Using Large Screens Optimized for the Visual Needs of People with Dementia
Scientific Title
Effectiveness of Reminiscence Therapy Using Large Screens Optimized for the Visual Needs of People with Dementia
Scientific Title:Acronym
Effectiveness of Reminiscence Therapy Optimized for the Visual Needs of People with Dementia
Region
| Japan |
Condition
Condition
older adults with dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether reminiscence therapy, optimized for the visual characteristics of people with dementia, can alleviate their behavioral and psychological symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Behavioral and psychological symptoms of dementia (measured using NPI-NH)
Key secondary outcomes
Caregiver burden(NPI-NH), Depression(GDS-15), Cognitive Function(MMSE)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The experimental group participated in reminiscence therapy once a week for five weeks, with each session lasting 60 minutes. During the treatment, slide images projected onto a large screen were used as reminiscence stimuli. This intervention was conducted in small groups of 8 to 20 participants./
Interventions/Control_2
During this period, the control group received standard occupational therapy interventions, including handicrafts, singing, and physical exercises.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants had to have a medical diagnosis of dementia, be able to hold simple everyday conversations.
Key exclusion criteria
Participants with other mental illnesses, such as schizophrenia, and those with severely impaired eyesight that prevents them from recognizing the content displayed on the large screen.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Asano |
Organization
Akita University, Graduate School of Health Science
Division name
Department of Occupational Therapy
Zip code
010-8543
Address
1-1-1 Hondo, Akita City
TEL
018-884-6536
tasano@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Asano |
Organization
Akita University, Graduate School of Health Science
Division name
Department of Occupational Therapy
Zip code
010-8543
Address
1-1-1 Hondo, Akita city
TEL
018-884-6536
Homepage URL
tasano@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University, Graduate School of Health Science
Address
1-1-1 Hondo, Akita city
Tel
018-884-6536
tasano@hs.akita-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 | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
Results
During the reminiscence therapy intervention period, significant improvements were observed in BPSD, caregiver burden, and MMSE scores. However, no significant differences were found in GDS-15.
Results date posted
| 2025 | Year | 05 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066091
