UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053102 |
|---|---|
| Receipt number | R000060598 |
| Scientific Title | An Empirical Study on the Prevention of Social Isolation and Loneliness among Middle-aged and Older Men |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2024/06/25 18:15:30 |
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Basic information
Public title
An Empirical Study on the Prevention of Social Isolation and Loneliness among Middle-aged and Older Men
Acronym
Social Isolation and Loneliness among Middle-aged and Older Men
Scientific Title
An Empirical Study on the Prevention of Social Isolation and Loneliness among Middle-aged and Older Men
Scientific Title:Acronym
Social Isolation and Loneliness among Middle-aged and Older Men
Region
| Japan |
Condition
Condition
Healthy older people or older people with mild frailty who live in community
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This project aims to implement Men's Shed, a community space for men, in Japan. The purpose of this study is to verify whether the Men's Shed functions effectively as a primary prevention system for social isolation and loneliness among middle-aged and older men, and whether it has a positive impact on their health, based on field investigations and psychological, brain, and health examinations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental functioning (loneliness, depression), social identity, and participation in activities at one and two years after the intervention
Key secondary outcomes
Health status, cognitive function, subjective well-being, brain structure, and brain function at one and two years after the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Participants in the intervention group belong to and participate in a Men's shed, which is a social activity in their community. In the Men's Shed, members gather in their own "base (shed)" and engage in a variety of activities according to their preferences, skills, and environment. They divide and manage their own roles. Participants can decide how often and when they want to participate in the shed according to their own availability and preferences. The duration of the program is two years.
Interventions/Control_2
Participants in the control group participate in local social activities outside of the Men's Shed. Participants can decide the type of social activities, frequency, and time of participation according to their convenience and preference. However, the type of social activities depends on the social resources in the community where the participants live. The duration of the program is two years.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Those who
- live in the suburbs of Sapporo
- can speak daily conversation
- can communicate in Japanese
Key exclusion criteria
Hospitalized patients
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Takashima |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
0600812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
TEL
011-706-3380
risa-t@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Takashima |
Organization
Hokkaido University
Division name
Department of Rehabilitation Science, Faculty of Health Sciences
Zip code
0600812
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
TEL
011-706-3380
Homepage URL
risa-t@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Risa Takashima
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Expert committee of faculty of health sciences of Hokkaido university
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan
Tel
011-706-3316
shomu@hs.hokudai.ac.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
地域の会館や施設等（Public halls and facilities in community）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2027 | 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 | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060598
