UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056801 |
|---|---|
| Receipt number | R000064733 |
| Scientific Title | Information support using personal health records for dementia prevention: Intervention Study |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2026/01/26 08:08:27 |
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Basic information
Public title
Supporting dementia prevention using ICT
Acronym
ICT and Dementia prevention
Scientific Title
Information support using personal health records for dementia prevention: Intervention Study
Scientific Title:Acronym
Intervention study for dementia prevention using personal health record
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is important to encourage people with mild cognitive impairment (MCI) or those at a stage where forgetfulness is a concern to visit a medical institution at the appropriate time. However, the proportion of older people in the general population who indicate a willingness to undergo regular dementia screening tests is low, and at the same time, considering the medical costs of blood tests and biomarkers used to diagnose MCI and the time burden of testing, it is suggested that older people with MCI levels may not see significant benefits. In recent years, it has been recommended that nurses and others use tablet-based cognitive function testing applications as a diagnostic aid tool. Apps for cognitive function assessment are also being developed in Japan, including one that can visualise an individual's cognitive function over time as a personal health record(PHR).The aim of this study is to examine whether, by utilising these apps, the individual can freely learn about changes in his/her own cognitive function over time, share the information with medical professionals, and provide the necessary information at the appropriate time, leading to behavioural changes in dementia prevention and early medical consultation, and ultimately to the prevention of dementia progression.
Basic objectives2
Others
Basic objectives -Others
The PHR is used for one year to measure the effectiveness of behaviour change for dementia prevention and ultimately maintenance of cognitive function, by monitoring one's own cognitive function status and receiving advice from nursing professionals.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function (MoCA-J): 6 months and One year after using PHR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The brain fitness trainer CogEvo (Total Brain Care) and LINE are installed on the subject's smartphone, tablet or PC at the start of the intervention and can be used freely at home for one year. Changes in cognitive function over time are stored by the individual and the principal investigator in the CogEvo brain fitness trainer, and information can be shared online, which is used as a PHR. The principal investigator checks the cognitive function and usage status (measurement history) at the end of each month, and sends information and advice on dementia prevention via LINE messages, depending on the condition.
Interventions/Control_2
Control group: The MCI Handbook to Energise the Brain and Body (National Institute for Longevity Sciences) will be distributed at the briefing session,followed by no intervention.
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 living in Akashi City and Kobe City, Hyogo Prefecture, who are concerned about memory loss and have been diagnosed with MCI in the past.
(2) Persons who are able to obtain written consent to participate in the study of their own free will after receiving a full explanation of their participation in the study and with sufficient understanding.
(3) Persons aged 65 years or older at the time of obtaining consent.
Key exclusion criteria
(1) People with a diagnosis of dementia or who scored less than 780 on the CogEvo brain fitness trainer in the baseline survey (because a score of less than 23 on the Mini-Mental State Examination is considered to be equivalent to dementia).
(2) People with visual impairment (because the test includes a colour discrimination test).
(3) People who are taking antipsychotic medication
(4) Other people whom the principal investigator judges to be unsuitable as research subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YOKO |
| Middle name | |
| Last name | AIHARA |
Organization
Okayama University
Division name
Faculty of Health Science
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ky Okayama City
TEL
0862356903
ayohko99@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Aihara |
Organization
Okayama University
Division name
Faculty of Health Sciences
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku Okayama City
TEL
0862356903
Homepage URL
ayohko99@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
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
Okayama University IRB Administration Office
Address
2-5-1 Shikata-cho, Kita-ku Okayama City
Tel
0862356503
mae6605@adm.okayama-u.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 | 01 | 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
10
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
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064733
