UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058386 |
|---|---|
| Receipt number | R000066753 |
| Scientific Title | Supporting Community Participation of Older Adults Living Alone after Relocation (Welcome Project) |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/07 13:45:17 |
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Basic information
Public title
Supporting Community Participation of Older Adults Living Alone after Relocation (Welcome Project)
Acronym
Welcome Project
Scientific Title
Supporting Community Participation of Older Adults Living Alone after Relocation (Welcome Project)
Scientific Title:Acronym
Welcome Project
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Relocation is a high-risk life event for older adults living alone, as failure to build community ties may lead to a decline in mental health. In contrast, community hubs have observed that professional-facilitated interactions foster connections and mutual support among residents. This study investigates the impact of post-relocation support on psychological well-being.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is psychological well-being measured by the CASP-19, which encompasses four domains: pleasure/enjoyment of life, control, autonomy, and self-realization.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Individuals who responded to the post-relocation survey and expressed interest in receiving a visit-based support program, in which a professional accompanies them to a local community hub and facilitates interaction with other residents.
Interventions/Control_2
Individuals who responded to the post-relocation survey but did not wish to receive support.
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
1.Individuals aged 65 years or older who have recently relocated to Takashimadaira Danchi 2-chome.
2.Living alone.
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okamura |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
0339643241
tokamura@tmig.or.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Yamashita |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
0339643241
Homepage URL
yama0531@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Mari Yamashita
Funding Source
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
0339643241
yama0531@tmig.or.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 11 | 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
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066753
