UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059600 |
|---|---|
| Receipt number | R000068184 |
| Scientific Title | The effects of picture books on older people with cognitive decline and readers |
| Date of disclosure of the study information | 2025/10/31 |
| Last modified on | 2025/10/31 11:23:11 |
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Basic information
Public title
The influence of picture books on older people and readers
Acronym
The effects of picture books on older people and readers
Scientific Title
The effects of picture books on older people with cognitive decline and readers
Scientific Title:Acronym
The effects of picture books on older people with cognitive decline and readers
Region
| Japan |
Condition
Condition
Dementia, Mild Cognitive Impairment
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of using picture books in older people with cognitive decline and readers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Global Impression- Improvement
Key secondary outcomes
MMSE, CDR, LS-100, VAS on Mood, VAS on Enjoyment, VQ, ACIS, Philadelphia Geriatric Center Affect Rating Scale, Attitudes dementia scale, Dementia knowledge scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The participants receive 60 minutes of individualized activity using a picture book a at once.
Interventions/Control_2
The participants receive 60 minutes of individualized activity no using a picture book a at once.
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
The study participants comprise older people aged 65 years and older at cooperating study sites who meet all inclusion criteria and do not meet any exclusion criteria. The inclusion criteria were a Mini Mental State Examination(MMSE)s' score of 27 or less or those diagnosed with MCI or dementia by a physician and those who agreed to participate in this study.
Key exclusion criteria
Exclusion criteria were defined as individuals with severe cognitive impairment (MMSE < 10) or those unable to communicate verbally.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Natsumi |
| Middle name | |
| Last name | Kimura |
Organization
Fukushima Medical University
Division name
Department of Occupational Therapy, School of Health Sciences
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Fukushima, Japan
TEL
024-581-5503
k-natsu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Kimura |
Organization
Fukushima Medical University
Division name
Department of Occupational Therapy, School of Health Sciences
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Fukushima, Japan
TEL
024-581-5503
Homepage URL
k-natsu@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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 Certified Review Board
Address
1 Hikariga-oka, Fukushima City, Fukushima, 960-1295 Japan
Tel
024-547-1825
fmucrb@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 | 10 | Month | 31 | 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
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | 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 | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068184
