UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056516 |
|---|---|
| Receipt number | R000064583 |
| Scientific Title | Usability of the cognitive training App "Atama no Dojo, ver.App" for healthy elderly residents and comparison with a existing cognitive training App. |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2024/12/20 13:15:25 |
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Basic information
Public title
Usability of the cognitive training App "Atama no Dojo, ver.App" for healthy elderly residents and comparison with a existing cognitive training App.
Acronym
Usability of the cognitive training App "Atama no Dojo, ver.App" for healthy elderly residents and comparison with a existing cognitive training App.
Scientific Title
Usability of the cognitive training App "Atama no Dojo, ver.App" for healthy elderly residents and comparison with a existing cognitive training App.
Scientific Title:Acronym
Usability of the cognitive training App "Atama no Dojo, ver.App" for healthy elderly residents and comparison with a existing cognitive training App.
Region
| Japan |
Condition
Condition
dementia prevention
Classification by specialty
| Rehabilitation medicine | Dental medicine | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Identify factors that influence the acquisition of operational skills for brain training apps.
2.Examine the impact of individual characteristics on engagement with cognitive training apps.
3.Evaluate the effects of incorporating novelty and familiarity into the task content.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Amount of assistance required for skill acquisition using the "App Operation Practice Checklist."
2.3. Temporal changes in usage logs for each app (frequency of use, engagement time).
Key secondary outcomes
1.
i. Proficiency in app operation on devices: "Questionnaire on Smartphone Usage"
ii. Cognitive function: Neuropsychological tests (MMSE-J, TMT-J, Digit Span Test, Tapping Span Test, Modified Stroop Test)
2.3.
i. Cognitive function: Neuropsychological tests (MMSE-J, TMT-J, Digit Span Test, Tapping Span Test, Modified Stroop Test)
ii. Enjoyment and satisfaction: Flow Scale, NPS (Net Promoter Score), "Post-App Usage Questionnaire (1-Month)"
iii. Psychosocial factors: Self-efficacy (GSES), Depression (GDS), Health Literacy (HLS-Q12)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use the cognitive training app "Atama no Dojo App Version" in daily life.
Interventions/Control_2
Use the existing commercial cognitive training app "CogEvo" in daily life.
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women aged 65 and older residing in the community who own and use smartphones regularly.
Individuals capable of recognizing text (in Japanese) on the screen of their device and performing input operations, with sufficient visual, motor, and cognitive functions.
Participants with an MMSE score of 24 or higher (since the study targets individuals living independently in the community, it is generally assumed that their MMSE score will be 24 or higher. However, if participants with an MMSE score of 23 or lower are identified, they will be categorized separately and allowed to continue using the app).
Key exclusion criteria
Individuals living outside their own homes, such as in care facilities, receiving assistance from others in daily life.
Those who were unable to independently master the operation of the app used in this study within the allotted practice time. (While their participation, evaluation, and app usage will be conducted in the same manner as eligible participants, taking into account relationships with other participants, they will be treated as dropouts if they do not actually use the app.)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsunehiro |
| Middle name | |
| Last name | Otsuka |
Organization
Hyogo Medical University
Division name
Faculty of rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima Cyuouku Kobe Hyogo
TEL
0783043185
ts-ootsuka@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsunehiro |
| Middle name | |
| Last name | Otsuka |
Organization
Hyogo Medical University
Division name
Faculty of rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima Cyuouku Kobe Hyogo
TEL
0783043185
Homepage URL
ts-ootsuka@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University, Faculty of Rehabilitation, Tsunehiro Otsuka
Institute
Department
Personal name
Tsunehiro Otsuka
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University ethics committee
Address
1-1 Mukogawacyo Nishinomiya Hyogo
Tel
0798456111
chizai@hyo-med.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 | 12 | Month | 25 | 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
41
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
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2024 | 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 | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064583
