UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052772 |
|---|---|
| Receipt number | R000060219 |
| Scientific Title | Effects of eSports participation on subjective well-being among older adults: A cluster randomized-controlled study |
| Date of disclosure of the study information | 2023/11/14 |
| Last modified on | 2023/11/12 13:21:02 |
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Basic information
Public title
Effects of eSports on subjective well-being among older adults
Acronym
Effects of eSports on subjective well-being among older adults
Scientific Title
Effects of eSports participation on subjective well-being among older adults: A cluster randomized-controlled study
Scientific Title:Acronym
Effects of eSports participation on subjective well-being among older adults: A cluster randomized-controlled study
Region
| Japan |
Condition
Condition
To examine the effects of eSports on subjective well-being among older people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of eSports on subjective well-being among older people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Ikigai-9
Key secondary outcomes
Changes in life satisfaction, happiness, self-rated physical health, self-rated mental health, interaction with friends and family, frequency of going out, participation in senior clubs, laughing, etc.
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
3-month eSports program, once per a week
Interventions/Control_2
Usual activities
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) People who can communicate in Japanese
(2) Aged 60 years or older
(3) People who consent to participate in the study
Key exclusion criteria
(1) People who do not consent to participate in the study
(2) People who are recommended not to play video games by their doctors
(3) People who are considered not appropriate to participate in the study by the study team
Target sample size
276
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakagomi |
Organization
Center for Preventive Medical Sciences, Chiba University, Chiba, Japan
Division name
Department of Social Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoicho, Inage Ward, Chiba
TEL
043-251-1111
anakagomi0211@chiba-u.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakagomi |
Organization
Center for Preventive Medical Sciences, Chiba University, Chiba, Japan
Division name
Department of Social Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoicho, Inage Ward, Chiba
TEL
043-251-1111
Homepage URL
anakagomi0211@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Atsushi Nakagomi
Funding Source
Organization
Research Institute of Science and Technology for Society
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Chiba University
Address
1-8-1Inohaba, Chuo-ku, Chiba, Chiba
Tel
043-251-1111
inohana-rinri@chiba-u.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
| 2023 | Year | 11 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 12 | 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
| 2023 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
