UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058785 |
|---|---|
| Receipt number | R000067149 |
| Scientific Title | Investigating Behavioral Changes Among Older Adults in Response to Personalized Interventions Aimed at Enhancing Cognitive Reserve |
| Date of disclosure of the study information | 2025/08/13 |
| Last modified on | 2025/08/13 14:54:04 |
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Basic information
Public title
Development of tailor-made behavior modification program based on cognitive function simulation, main study
Acronym
PREPARE study, main study
Scientific Title
Investigating Behavioral Changes Among Older Adults in Response to Personalized Interventions Aimed at Enhancing Cognitive Reserve
Scientific Title:Acronym
Investigating Behavioral Changes Among Older Adults in Response to Personalized Interventions Aimed at Enhancing Cognitive Reserve
Region
| Japan |
Condition
Condition
Healthy adults over the age of 65
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This exploratory study aims to investigate the extent to which the use of a cognitive reserve simulation app, in addition to educational interventions for dementia prevention, promotes behavior change toward dementia-preventive actions among healthy older adults with a low risk of dementia. The study will also examine the use of cognitive training tools and the duration of sustained behavioral changes.
Basic objectives2
Others
Basic objectives -Others
This exploratory study aims to examine the extent to which the use of a cognitive reserve simulation app, in addition to educational interventions for enhancing cognitive reserve, can promote behavior change aimed at improving cognitive reserve among healthy older adults with a low risk of dementia. Furthermore, the study will investigate the sustainability of these behavioral changes by assessing the use of cognitive training tools and conducting a follow-up survey on daily lifestyle behaviors over a six-month period.
This study is an expanded follow-up to a pilot study conducted in 2024, designed to address the aforementioned clinical questions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-the evaluation calculated by Cognitive Researve Simulation App.
-the test score of Cognitive Function Training Tool
Key secondary outcomes
-the score of Health Belief Model for Dementia Prevention
-the score of MMSE
-the score of CQtest
-the score of adherence test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The cognitive reserve simulation app will be used once at baseline.
Interventions/Control_2
The cognitive reserve simulation app will not be used at baseline.
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
1. Individuals aged 65 years or older
2. Individuals who have never been diagnosed with dementia
3. Individuals who have provided written informed consent to participate in this study
4. Individuals who are able to use a smartphone or tablet with access to the internet
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from this study
1. Individuals who have difficulty responding to assessment scales or operating a tablet device
2. Individuals with an MMSE score of 23 or lower
3. Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University
Division name
Center for Preventive Medicine
Zip code
106-0041
Address
7th Floor, Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo, Japan
TEL
03-3353-1211
mimura.a7@keio.jp
Public contact
Name of contact person
| 1st name | Taishiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Keio University School of Medicine
Division name
Center for the Promotion of Interdisciplinary Research in Medicine and Life Science (PIRMS)
Zip code
106-0041
Address
7th Floor, Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo
TEL
03-5363-3219
Homepage URL
tkishimoto@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Splink Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Keio University, School of Medicine
Address
35 Shinanomachi Shinjuku Tokyo
Tel
0353633503
med-rinri-jimu@adst.keio.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
港区シルバー人材センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | 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
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 | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067149
