UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046769 |
|---|---|
| Receipt number | R000053356 |
| Scientific Title | Effectiveness of the community-based intervention promoting intergenerational support |
| Date of disclosure of the study information | 2022/01/28 |
| Last modified on | 2022/01/28 20:24:58 |
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Basic information
Public title
Effectiveness of the community-based intervention promoting intergenerational support
Acronym
Effectiveness of the community-based intervention promoting intergenerational support
Scientific Title
Effectiveness of the community-based intervention promoting intergenerational support
Scientific Title:Acronym
Effectiveness of the community-based intervention promoting intergenerational support
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to develop a community-based intervention program promoting intergenerational support, and examine its effects on instrumental support and generativity among community-dwelling adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Generativity
Key secondary outcomes
Neighborhood trust/reciprocity
Instrumental support
Emotional support
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Organizing the community meeting and conducting it regularly (23 times)
Holding the project logo and slogan contest
Distributing the goods such as badges, uniforms, banners, and document folders
Training the volunteer staff members
Providing intergenerational programs and events (63 times)
Interventions/Control_2
No treatment
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
| 25 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Residents in the study area at the baseline survey
Key exclusion criteria
Those who live in nursing care homes
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Fujiwara |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research team for social participation and community health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo, Japan
TEL
03-3964-3241
fujiwayo@tmig.or.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Fujiwara |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research team for social participation and community health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo, Japan
TEL
03-3964-3241
Homepage URL
fujiwayo@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae-cho, Itabashi, Tokyo, Japan
Tel
03-3964-3241
fujiwayo@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.jst.go.jp/ristex/funding/files/JST_1115140_15657097_fujiwara_ER.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.jst.go.jp/ristex/funding/files/JST_1115140_15657097_fujiwara_ER.pdf
Number of participants that the trial has enrolled
5211
Results
Multivariable analysis showed that neighborhood trust and reciprocity were significantly improved in the intervention group compared with the control group.
Results date posted
| 2022 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the intervention group, the mean age was 57.7 years, and 40.6% of them were males. In the control group, the mean age was 57.7 years, and 39.7% of them were males.
Participant flow
Of 15,099 eligible residents, 5,211 adults responded to the baseline survey. A total of 1,359 participants were excluded from the follow-up survey, 2,518 participants completed both surveys.
Adverse events
None
Outcome measures
Neighborhood trust and reciprocity
Instrumental social support
Emotional social support
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | 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 | 28 | Day |
Last modified on
| 2022 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053356
