UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051888 |
|---|---|
| Receipt number | R000059202 |
| Scientific Title | Effects of Community Sheds on Social Isolation and Loneliness and Mental and Physical Health~Non-randomized controlled trial~ |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/08/10 17:11:43 |
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Basic information
Public title
Effects of Community Sheds on Social Isolation and Loneliness and Mental and Physical Health~Non-randomized controlled trial~
Acronym
Effects of Community Sheds on Social Isolation and Loneliness and Mental and Physical Health~Non-randomized controlled trial~
Scientific Title
Effects of Community Sheds on Social Isolation and Loneliness and Mental and Physical Health~Non-randomized controlled trial~
Scientific Title:Acronym
Effects of Community Sheds on Social Isolation and Loneliness and Mental and Physical Health~Non-randomized controlled trial~
Region
| Japan |
Condition
Condition
Men over 40 years old
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine in a randomized controlled trial whether community sheds, new places for men, can prevent social isolation and loneliness among men (especially older men) over 40 years old
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Online Social Identity Mapping (oSIM)
Japanese version of the Loneliness Scale (short 10-item version)
Measured once every year
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
CS is an activity-based activity program for men over 40 years old, based on the concept of a "secret base for adult men. The main activities are woodworking (coaster making, furniture making) and gardening (coffee bean making, charcoal kiln making). In other cases, participants think of things they would like to do on their own initiative, make proposals at CS meetings, and recruit others to join them in implementing the activities.
The intervention period will be one year, with annual evaluations planned.
Interventions/Control_2
A control group that does not participate in CS. Non-intervention group.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Males who are 40 years of age or older at the time of obtaining research consent
Those who live in the community not in an institution
Those who are able to commute to the site by themselves or by public transportation.
Those who can commute to the study site by themselves or by public transportation.
Key exclusion criteria
Those who have obvious cognitive impairment and may not be able to carry out CS activities.
Those who have communication problems in conducting CS activities (Violent behavior, etc.).
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
kumamoto health science university
Division name
Department of rehabilitation
Zip code
8615598
Address
325 Izumi-machi,kita-ku,kumamoto,japan
TEL
0962752283
m.takashi0627@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
kumamoto health science university
Division name
Department of rehabilitation
Zip code
8615598
Address
325 Izumi-machi,kita-ku,kumamoto,japan
TEL
0962752283
Homepage URL
m.takashi0627@gmail.com
Sponsor or person
Institute
kumamoto health science university Takashi Matsuo
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency Research Institute of Science and Technology for Society
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University, Hokkaido University, Nagasaki University, Kochi University of Technology, Nagoya University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kumamoto health science university
Address
325 Izumi-machi,kita-ku,kumamoto,japan
Tel
0962752283
m.takashi0627@gmail.com
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 | 08 | Month | 10 | 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 | 06 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 29 | 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 | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059202
| 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 |
