UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055186 |
|---|---|
| Receipt number | R000063054 |
| Scientific Title | Investigating elderly people's adherence to individualized behavioral change proposals to improve cognitive reserve: A pilot study |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2025/02/06 17:04:24 |
* 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
Investigating elderly people's adherence to individualized behavioral change proposals to improve cognitive reserve: A pilot study
Acronym
Investigating elderly people's adherence to individualized behavioral change proposals to improve cognitive reserve: A pilot study
Scientific Title
Investigating elderly people's adherence to individualized behavioral change proposals to improve cognitive reserve: A pilot study
Scientific Title:Acronym
Investigating elderly people's adherence to individualized behavioral change proposals to improve cognitive reserve: A pilot study
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how the use of a simulation app to predict cognitive function in addition to prevention education on dementia affects Health Belief in healthy older people.
Basic objectives2
Others
Basic objectives -Others
To examine how the use of a simulation app to predict cognitive function in addition to prevention education on dementia affects Health Belief in healthy older people.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction, Japanese version
Key secondary outcomes
MMSE, CQ test, Adherence research
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
App use and disease education
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People over 65 years old
2. Those who have never been diagnosed with dementia
3. Those who have given written consent to participate in this study
4. Those who can use a smartphone or tablet that can access the web
Key exclusion criteria
1. Those who have difficulty responding to rating scales or operating a tablet
2. Those with MMSE score of 23 or less
3. Those who are deemed unsuitable for conducting this research by the research director or researcher
Target sample size
30
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
Azabudai Hills Mori JP Tower 7th Floor, 1-3-1 Azabudai, Minato-ku, Tokyo
TEL
03-5363-3685
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
Hills Joint Research Laboratory for Future Preventive Medicine and Wellness
Zip code
106-0041
Address
Hills Mori JP Tower 7th Floor, 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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
03-3353-1211(62014)
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
| 2024 | Year | 08 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063054
