UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030595 |
|---|---|
| Receipt number | R000034939 |
| Scientific Title | A comprehensive study to develop and investigate the effect of a cognitive intervention program |
| Date of disclosure of the study information | 2017/12/27 |
| Last modified on | 2020/07/06 13:00:53 |
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Basic information
Public title
A comprehensive study to develop and investigate the effect of a cognitive intervention program
Acronym
Cognitive intervention utilizing GO game:iGO-kochi program
Scientific Title
A comprehensive study to develop and investigate the effect of a cognitive intervention program
Scientific Title:Acronym
Cognitive intervention utilizing GO game:iGO-kochi program
Region
| Japan |
Condition
Condition
community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a cognitive intervention program through intellectual stimulation utilizing GO game and to investigate the efficacy of the program for community dwelling older adults.
We also investigate the intervention's effect comparing participants who had social interactions and who had no special social interaction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Working Memory(Verbal function:Digit Span Test from the Wechsler Adult Intelligence Scale version III,Visual function:Visual Memory Span from the Wechsler Memory Scale Revised)
Key secondary outcomes
Mini Mental State Examination-Japanese,Japanese version of Montreal Cognitive Assessment,Logical memory subscale from the Wechsler Memory Scale Revised, Verbal Fluency tests,Trail Making Test Part A and Part B,Japanese version of WHO-Five well-being Index,Memory complaint,Frequency of going outdoors,Frequency of social interaction,Frequency of participation in group activity,Frequency of intellectual activity,Fluorodeoxyglucose-position emission tomography(FDG-PET)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants attend the GO game classes lectured by GO instructors on face to face. The GO game classes are held once a week, 1 hour each time and a total of 12 times in the community space.
Interventions/Control_2
Participants individually attend the GO game program which is same period, same frequency, and same contents as Intervention1, using a tablet-type devise.
Interventions/Control_3
Participants of the control group attend lectures on health maintenance once a month and a total of three times.
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
(i)age 65 years and older; (ii)ADL-independent(iii)no experience of the GO game
Key exclusion criteria
diagnosed dementia
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
TEL
03-3964-3241
suzukihy@tmig.or.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Iizuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
TEL
03-3964-3241
Homepage URL
aiizuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culture,Sports,Science and Technology of Japan
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
Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae-cho,Itabashi-ku,Tokyo,Japan
Tel
03-3964-3241
naomi_hasegawa@tmghig.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
| 2017 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16K13036/
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/gps.5024
Number of participants that the trial has enrolled
91
Results
The VMST scores significantly improved after the intervention in both the FG and NFG, and the effect size of the FG was greater than that of the NFG. The VMSB scores significantly improved after the intervention in the FG. Regional cerebral glucose metabolism was significantly increased in the left middle temporal gyrus and bilateral putamen in the FG and NFG. At the follow-up, mean score of WHO-5 significantly improved over time in the participants who were continuing GO.
Results date posted
| 2020 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Community-dwelling older adults
Participant flow
The 91 participants who provided informed
consent were randomly assigned to one of the following three groups:(1)a face to face group (FG) (n = 30); (2)a non face to face group(NFG) (n = 30); or (3)an active control group (CG) (n = 31). Two participants in the FG, one in the NFG, and six in the CG dropped out of the intervention program for the following reasons: (1) in the FG, one participant was hospitalized with a severe medical disorder, and another refused to attend the Go classes; (2) in the NFG, one participant refused to use the tablet computer; and (3) in the CG, four participants refused to be assigned to the CG, one was hospitalized with a severe medical disorder, and one refused to participate in the follow up assessment.
Adverse events
none
Outcome measures
Visual working memory:Visual memory span test(forward, backward)
Verbal working memory:Digit span test(forward, backward)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 12 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034939
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