UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051427 |
|---|---|
| Receipt number | R000058589 |
| Scientific Title | Investigating the effects of digital art learning on cognitive and psychological functioning |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/23 14:29:55 |
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Basic information
Public title
Investigating the effects of digital art learning on cognitive and psychological functioning
Acronym
DIG-ART_COG-PSY
Scientific Title
Investigating the effects of digital art learning on cognitive and psychological functioning
Scientific Title:Acronym
DIG-ART_COG-PSY
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of digital arts learning programme on the neurocognitive and psychological wellbeing of older adults.
Basic objectives2
Others
Basic objectives -Others
Design of the art learning programme, adherance to programme, interview-based feedback.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The outcome will be measured through a range of neurocognitive and psychological assessment questionnaires and surveys (paper-based assessment).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group will join an art learning programme for 6 months (one 90-min lesson per week), as well as attending health lecture series (twice in the study duration).
Interventions/Control_2
Control group will participate in only health lecture series (twice in the study duration).
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Aged 65-74 (at the time of registration)
(2) Gender: any gender
(3) Beginners in painting (those who have never studied painting other than in compulsory art classes, or who have never painted on their own before)
(4) Those who can give written consent to participate in the research.
Key exclusion criteria
(1) Those who are unable to give informed consent
(2) Those with a history of dementia or neurological disease
(3) Those with severe visual or hearing impairment
(4) Those who are participating in other clinical studies
(5) Those who have other difficulties in carrying out the research.
Target sample size
80
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
Sendai-shi, Aoba-ku, Seiryou-chou, 4-1
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
Sendai-shi, Aoba-ku, Seiryou-chou, 4-1
TEL
022-717-8559
Homepage URL
yasuyuki.taki.c7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Yasuyuki TAKI
Funding Source
Organization
Wacom Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethical Committee
Address
Sendai-shi, Aoba-ku, Seiryou-chou 2-1
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
| 2023 | Year | 06 | 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
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 | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | 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
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058589
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
