UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056855 |
|---|---|
| Receipt number | R000064987 |
| Scientific Title | Examining the feasibility of implementing picture book-based reminiscence for older adults with cognitive decline: an intervention study |
| Date of disclosure of the study information | 2025/01/29 |
| Last modified on | 2025/08/28 20:45:11 |
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Basic information
Public title
Examining the feasibility of implementing picture book-based reminiscence for older adults with cognitive decline: an intervention study
Acronym
Examining the feasibility of implementing picture book-based reminiscence for older adults with cognitive decline: an intervention study
Scientific Title
Examining the feasibility of implementing picture book-based reminiscence for older adults with cognitive decline: an intervention study
Scientific Title:Acronym
Examining the feasibility of implementing picture book-based reminiscence for older adults with cognitive decline: an intervention study
Region
| Japan |
Condition
Condition
older adults with dementia
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Targeting older adults with dementia and their staff who live in Communal Daily Long-Term Care for a Dementia Patient, 1) we will examine the feasibility of verifying the effect of reminiscence therapy using picture books on the QOL and BPSD of elderly people with dementia. 2) We will examine methods to evaluate changes in the caregiver burden felt by staff who read aloud to them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL
Key secondary outcomes
BPSD(Behavioral and Psychological Symptoms of Dementia)
burden of care
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
Reading picture book to older adults with dementia 3minutes
Group Discussion 27minutes
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who have obtained consent from the individual and their families to participate in this study
Key exclusion criteria
Older adults with severe dementia
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Yamada |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Public Health
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima
TEL
0245471180
ya-hide@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Yamada |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Public Health
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima
TEL
0245471180
Homepage URL
ya-hide@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1, Hikarigaoka, Fukushima
Tel
0245471825
rs@fmu.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 | 01 | Month | 29 | 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
5
Results
A study examined (1) the feasibility of reminiscence therapy using a picture book with nostalgic Showa-era scenes and games on the quality of life and behavioral and psychological symptoms of dementia in older adult residents of communal daily long-term care for a dementia patient, and (2) changes in caregiver burden among staff. The therapy was conducted for 30 minutes once a week for four weeks. No significant change in QOL was found, but BPSD severity and caregiver burden were significantly reduced.
Results date posted
| 2025 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were older adult residents (mean age: 84.4 years, SD: 7.4 years) of communal daily long-term care for a dementia patient in Fukushima Prefecture. All participants had been diagnosed with Alzheimer's disease.
Participant flow
With the cooperation of staff working at a communal daily long-term care for a dementia patient, five older adults with dementia who consented to participate were included in the study. Consent was also obtained from the families of all five participants.
Adverse events
none
Outcome measures
Primary outcome:Quality of life of older adults with dementia
Secondary outcomes: Behavioral and psychological symptoms of dementia (BPSD) in older adults with dementia and the caregiving burden experienced by care workers
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2025 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064987
