UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000030595
Receipt No. 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 (Ver. 4)

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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
Email 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
Email aiizuka@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034939