UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054471 |
|---|---|
| Receipt number | R000062075 |
| Scientific Title | An effect evaluation of community organizing intervention by accompanied support with local municipalities for the promotion of a healthy aging society: a protocol for a cluster randomized controlled trials. |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/12/12 11:07:08 |
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Basic information
Public title
Municipal Support for Advancing Data-Driven Management of Community-based Integrated Care: A Cluster Randomized Controlled Trial
Acronym
MUSUBI Study
Scientific Title
An effect evaluation of community organizing intervention by accompanied support with local municipalities for the promotion of a healthy aging society: a protocol for a cluster randomized controlled trials.
Scientific Title:Acronym
An effect evaluation of community organizing intervention by accompanied support with local municipalities for the promotion of a healthy aging society: a protocol for a cluster randomized controlled trials.
Region
| Japan |
Condition
Condition
Functional Ability
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To promote a healthy aging society, we clarify effective municipal support methods and evaluate their intervention effects.For this purpose, we use JAGES-HEART, a support tool designed for the development of a comprehensive community care system based on the social determinants of health (SDH).This tool facilitates data utilization and organizational collaboration, enabling local government staff and residents to organize community efforts towards healthier towns.We evaluate the intervention effects through a cluster-randomized controlled trial using the Functional Ability Index of older people who have not received long-term care certification as the primary outcome measure. We will also assess the effects of the intervention on broader community issues beyond health, such as environmental awareness and disaster preparedness, as well as its co-benefits in participating municipalities.Additionally, the study will evaluate the effects on the prevention of need for care, work engagement of municipal elderly care staff, policy-making capabilities, and the status of multidisciplinary collaboration within these municipalities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Ability Index
Key secondary outcomes
Individual level:
1)Social Isolation 2)Loneliness 3)Poverty 4)Social Withdrawal 5)Cognitive Function 6)Higher-level Functional Capacity 7)Functional Ability Index Domain Score 8)JAGES Human Flourishing Score
Municipality Level:
1)Long-term Care Benefit 2)Community Social Capital 3)Rate of Social Participation 4)Incentive Grant Score 5)Long-term Care Prevention Program Report Points 6)Rate of New Long-term Care Certification
7)Medical and Long-term Care Benefits 8)Estimated Reduction in Greenhouse Gas Emissions Through Energy Sharing in Community Settings
Municipal staff evaluation:
1)9 items Utrecht Work Engagement Scale Japanese version 2)Workplace Social Capital 3)Administrative Execution Capability Scale 4)Subjective and Objective Multidisciplinary Collaboration 5)Longitudinal and Transversal Organizational Collaboration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Both the intervention group and the comparison group will receive the following interventions.
-Provision of Epidemiological Evidence
-Peer Support and Information Provision via Mailing List
-Provision of Community Diagnosis Data and Target Area Selection Sheets
-Organization of Joint Research Meetings for mucipalities
Interventions/Control_2
In addition to the intervention described in Intervention 1, the intervention group will receive the following interventions.
-Assign a responsible researcher in each municipality and provide hands-on support tailored to the situation of each municipality to promote community organization.
-Support for identifying community issues and resources by actively utilizing the provided community diagnosis data
-Support for inter-organizational collaboration and multi-departmental collaboration
-Support for planning and implementing long-term care prevention measures
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
[Evaluation for older people (census survey)]
1)They are participating in the JAGES cohort study conducted in 2022.
2)They are 65 years or older at the time of participation in the study.
3)They are not certified as needing long-term care insurance (support levels 1-2 and care levels 1-5) at the time of participation in the study.
[Evaluation for older people (Sample Survey Municipalities)]
1)They are 65 years or older at the time of participation in the study.
2)They are not certified as needing long-term care insurance (support levels 1-2 and care levels 1-5) at the time of participation in the study.
3)Those who meet criteria 1) and 2) are randomly selected from each elementary school district within the municipality, with a minimum of 150 individuals. If fewer than 150 individuals meet these criteria in a district, all eligible individuals residing in that district are included in the study.
4)Among those sampled in 3), only those who responded to the distributed questionnaire are included.
[Municipal Staff Evaluation]
1)They are employees of the municipal community-based integrated care promotion department.
Key exclusion criteria
[Evaluation for older people (Census Survey)]
1)They are under 65 years old at the time of participation in the study.
2)They are certified as needing long-term care insurance at the time of participation in the study.
[Evaluation for older people (Sample Survey Municipalities)]
1)They are under 65 years old at the time of participation in the study.
2)They are certified as needing long-term care insurance at the time of participation in the study.
3)If there are more than 150 individuals who meet criteria 1) and 2) in the elementary school district of the municipality, 150 individuals are randomly selected, and those who are not selected in this random sampling.
[Municipal Staff Evaluation]
None
Target sample size
92000
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kondo |
Organization
Graduate School of Medicine and School of Public Health, Kyoto university
Division name
Department of Social Epidemiology
Zip code
606-8501
Address
Science Frontier Laboratory Floor 2, Yoshida-konoe-cho, Sakyo-ku, Kyoto 606-8501
TEL
075-753-4355
contact@socepi.med.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Oda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Social Epidemiology
Zip code
606-8501
Address
Science Frontier Laboratory Floor 2, Yoshida-konoe-cho, Sakyo-ku, Kyoto 606-8501
TEL
075-753-4355
Homepage URL
jagesmusubi@socepi.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kyoto University Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501 JAPAN
Tel
81757534680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | 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
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062075
