UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060165 |
|---|---|
| Receipt number | R000068811 |
| Scientific Title | Development and Validation of the Japanese Version of the Dementia Prevention Awareness Test Based on the Health Belief Model |
| Date of disclosure of the study information | 2025/12/23 |
| Last modified on | 2025/12/22 16:40:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and Validation of the Japanese Version of the Dementia Prevention Awareness Test Based on the Health Belief Model
Acronym
Development and Validation of the Japanese Version of the Dementia Prevention Awareness Test Based on the Health Belief Model
Scientific Title
Development and Validation of the Japanese Version of the Dementia Prevention Awareness Test Based on the Health Belief Model
Scientific Title:Acronym
Development and Validation of the Japanese Version of the Dementia Prevention Awareness Test Based on the Health Belief Model
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a Japanese version of the MCLHB-DRR (Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction) scale, originally developed in English, and to verify its reliability and validity among healthy community-dwelling older adults in Japan.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to create a Japanese test to evaluate dementia prevention awareness among healthy older adults in Japan based on the Health Belief Model, and to verify its reliability and validity. Since an individual's awareness of dementia prevention is highly likely to reduce the risk of dementia onset, the development of this test can contribute to establishing an indicator for future interventional studies on dementia prevention awareness. Furthermore, through this study, we will measure dementia prevention awareness in the Japanese elderly population and compare its characteristics with previous studies conducted in other countries, allowing for an objective understanding of the characteristics and trends of this population.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reliability will be verified based on the scores of the developed test, using Cronbach's alpha, inter-item correlations, intraclass correlation coefficients (ICC), and test-retest reliability for each item.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Middle-aged and older adults aged 40 to 80 at the time of informed consent, who volunteered to participate in the study through Cross Marketing Inc., a survey research firm. (Participants will be recruited in numbers that align with the age and gender distribution ratios of the 2023 Japanese census.)
2. Individuals residing in Japan who are proficient in Japanese.
Key exclusion criteria
1. Those with complications or disabilities (e.g., psychiatric symptoms or physical impairments) that could interfere with the completion of the questionnaire survey used in this study.
2. Those deemed ineligible by the principal investigator or sub-investigators for any other reason.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University School of Medicine
Division name
Center for Preventive Medicine
Zip code
106-0041
Address
Azabudai Hills Mori JP Tower 5th Floor, 1-3-1 Azabudai, Minato-ku, Tokyo
TEL
03-5363-3492
tkishimoto@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
Zip code
106-0041
Address
7th Floor, Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo
TEL
0353633219
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Keio University, School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 23 | 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
500
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None to declear
Management information
Registered date
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068811
