UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053297 |
|---|---|
| Receipt number | R000060831 |
| Scientific Title | Development and Evaluation of a Digital Skills Learning Program for Dementia Prevention and Psychosocial Health Among Elderly Residents in a Community Setting |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/15 15:03:49 |
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Basic information
Public title
Development and Evaluation of a Digital Skills Learning Program for Dementia Prevention and Psychosocial Health Among Elderly Residents in a Community Setting
Acronym
Development and Evaluation of a Digital Skills Learning Program Among Elderly Residents
Scientific Title
Development and Evaluation of a Digital Skills Learning Program for Dementia Prevention and Psychosocial Health Among Elderly Residents in a Community Setting
Scientific Title:Acronym
Development and Evaluation of a Digital Skills Learning Program Among Elderly Residents
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of a digital skills learning program, developed for this research, on cognitive and psychosocial functions among elderly residents aged 65 and older living in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of cognitive functions (the Japanese version of MoCA) and Psychosocial functions (feelings of loneliness, social network, outdoor and living space activities, depression, motivation scores, anxiety, life satisfaction scales, and morale scales)
Key secondary outcomes
Subjective Health Perception/Objective Health Status/Satisfaction with the Program
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
| Behavior,custom | Other |
Interventions/Control_1
Three months of follow-up after a single 150-minute session in the digital skills learning class.
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) Individuals aged 65 or above, residing in Sendai City or nearby areas.
(2) Individuals who own a personal smartphone (either Android OS or iOS).
(3) Individuals who have understood the contents of the research and have provided written consent.
Key exclusion criteria
(1) Individuals with severe visual or hearing impairments.
(2) Individuals who do not understand Japanese.
(3) Individuals from whom informed consent cannot be obtained.
(4) Individuals currently participating in other clinical studies.
(5) Individuals whom the principal investigator deems unfit for participation in the trial.
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8559
Homepage URL
yasuyuki.taki.c7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
The Japan Foundation for Aging and Health
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 01 | Month | 10 | 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
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 31 | 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
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060831
