UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057047 |
|---|---|
| Receipt number | R000064986 |
| Scientific Title | The effect of communication through a picture book in elderly with cognitive decline: A feasibility pilot study |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/02/16 18:24:13 |
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Basic information
Public title
The effect of the communication through a picture book in elderly with cognitive decline: A feasibility pilot study
Acronym
The effect of the communication through a picture book in elderly with cognitive decline
Scientific Title
The effect of communication through a picture book in elderly with cognitive decline: A feasibility pilot study
Scientific Title:Acronym
The effect of the communication through a picture book in elderly with cognitive decline
Region
| Japan |
Condition
Condition
Mild cognitive impairment and dementia
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of reading a picture book depicting old tales from the Showa era together with elderly with cognitive decline and their caregivers, and telling old stories related to the book's contents, on the psychiatric symptoms, cognitive function, and QOL in elderly with cognitive declien, as well as the sense of care burden and QOL in caregivers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will be evaluated the QOL of the patients and their caregivers using the WHOQOL26 and Short QOL-D at eight weeks after the start of the study.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intrevention is reading a picture book depicting old tales from the Showa era together with elderly with cognitive decline and their caregivers, and telling old stories related to the book's contents
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly met by the diagnostic criteria of mild cognitive impairment or neurocognitive disorder according to DSM-5.
Key exclusion criteria
1. Elderly with cognitive decline due to mental illnesses such as schizophrenia or depression
2. Elderly people with severe dementia who cannot understand the contents of a picture book
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University School
Division name
Health Sciences
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima
TEL
0245815555
hhayashi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University School
Division name
Health Sciences
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima
TEL
0245815555
Homepage URL
hhayashi@fmu.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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 School
Address
1 Hikarigaoka, Fukushima, 960-1295,Japan
Tel
09019387374
c-kiban@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 | 02 | Month | 17 | 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 | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | 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 | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064986
