UMIN-CTR Clinical Trial

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
Email	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
Email	fujiwayo@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053356