UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057142 |
|---|---|
| Receipt number | R000065323 |
| Scientific Title | Feasibility, Acceptability, and Potential Efficacy of Cognitive Intervention Programs Using Go and Pair Go in US Older Adults |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/09/12 05:41:59 |
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Basic information
Public title
Pilot Testing of Go and Pair Go Game for Brain Health in US: Understanding Feasibility, Acceptability, and Impacts
Acronym
Go game for brain health in US
Scientific Title
Feasibility, Acceptability, and Potential Efficacy of Cognitive Intervention Programs Using Go and Pair Go in US Older Adults
Scientific Title:Acronym
Go and Pair Go game pilot testing in US
Region
| North America |
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 evaluate the impact of Go and Pair Go (Go played in pairs) on cognitive function, mental health, and social interaction. This includes feasibility and acceptability of Go and Pair Go as tools for health promotion in US older adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility and acceptability of the programs
Feasibility: attendance rate, reasons for absence, dropout rate, reasons for drop out, program satisfaction, program feedback
Acceptability: Likelihood of continuing Go/Pair Go, Likelihood of recommending Go/Pair Go to family or friends, perceived usefulness of Go/Pair Go
Key secondary outcomes
Cognitive function: Corsi Block-Tapping Test, Digit Span Test, Trail Making Test, Verbal Fluency Test, Mini-Mental State Examination, Montreal Cognitive Assessment
Mental health: the Geriatric Depression Scale, The University of California, Los Angeles Loneliness Scale, The Control, Autonomy, Self-realization, and Pleasure questionnaire, the WHO-5 Well-being Index, Memory complaints
Social network: Lubben Social Network Scale-6, the number of people they interacted with outside of the program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants will attend a Go program once a week for 90 minutes for a total of 12 sessions. Sessions comprise of lectures on basic rules, solving Go exercises, and playing Go.
Interventions/Control_2
The participants will attend a Pair Go program once a week for 90 minutes for a total of 12 sessions. The instructors will explain the rules specific to Pair Go , after which participants will solve practice problems and participate in Pair Go games with partners. After each game, a review session will be conducted to discuss strategies and reflect on gameplay to enhance learning and cooperation skills.
Interventions/Control_3
The participants will not attend any classes.
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. Community-dwelling older adults aged 65 years or older
2. Activity of daily livng independent
3. Not having any previous experience in playing Go
Key exclusion criteria
1. Having medical and psychiatric disorders affecting cognitive function and mental health status
2. Having diagnosis of dementia
3. Adults unable to consent
4. Individuals who do not understand English
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Iizuka |
Organization
The University of Iowa
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Department of Community and Behavioral Health, Collage of Public Health/ Research Team for Social Participation and Healthy Aging
Zip code
52242/ 173-0015
Address
Collage of Public Health Building 145 N. Riverside Drive Iowa City, IA, USA/ 35-2, Sakae-Cho, Itabashi-ku, Tokyo, Japan
TEL
319-335-2661
ai-yasunaga@uiowa.edu
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Iizuka |
Organization
The University of Iowa
Division name
Department of Community and Behavioral Health, Collage of Public Health
Zip code
52242
Address
Collage of Public Health Building 145 N. Riverside Drive Iowa City, IA, USA
TEL
319-335-2661
Homepage URL
ai-yasunaga@uiowa.edu
Sponsor or person
Institute
The University of Iowa
Institute
Department
Personal name
Funding Source
Organization
The Japan Pair Go Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Iowa
Address
Hardin Library, Suite 105A 600 Nweton Rd Iowa City, IA 52242-1098
Tel
319-335-6564
irb@uiowa.edu
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
The University of Iowa
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 24 | 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
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065323
