UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046667 |
|---|---|
| Receipt number | 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 | 2023/07/29 15:59:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
aiizuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
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
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
20
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because of the COVID-19 pandemic, the research progress has been delay.
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
| 2023 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
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 |
