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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046667
Receipt No. R000053239
Scientific Title Examination of the effect of GO intervention on psychological and social function
Date of disclosure of the study information 2022/01/19
Last modified on 2022/05/11

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Basic information
Public title Examination of the effect of GO intervention on psychological and social function
Acronym GO intervention using iGO-kochi program
Scientific Title Examination of the effect of GO intervention on psychological and social function
Scientific Title:Acronym GO intervention using 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 aim of this study is to examine the effect of GO intervention on psychological and social function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Well-being
Key secondary outcomes Instrumental Activities of Daily Living, Japanese Version of the UCLA Loneliness Scale Version3, social function (frequency of social interaction, frequency of going out, social network, social support), satisfaction of the program, attendance rate, reason for absence, mental health and behavioral changes.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Participants attend the GO game classes lectured by GO instructors. The GO game classes are held once a week, 1 hour each time, and a total of 3 months in the community space.
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 65 years and older; ADL-independent
Key exclusion criteria People who cannot come to the community space
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Okamura
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Promoting Independence of the Elderly
Zip code 1730015
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL 03-3964-3241
Email tokamura@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 1730015
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL 03-6905-6781
Homepage URL
Email aiizuka@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization Mayekawa Hitodukuri Zaidan
Organization
Division
Category of Funding Organization Non profit foundation
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
2022 Year 01 Month 19 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
2021 Year 10 Month 26 Day
Date of IRB
2021 Year 10 Month 26 Day
Anticipated trial start date
2022 Year 01 Month 19 Day
Last follow-up date
2022 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 18 Day
Last modified on
2022 Year 05 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053239

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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