UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050767 |
|---|---|
| Receipt number | R000057852 |
| Scientific Title | The impact of health-related social capital and meaningful work on health-related quality of life and care prevention among community-dwelling older adults |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2025/05/25 03:25:22 |
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Basic information
Public title
The impact of health-related social capital and meaningful work on health-related quality of life and care prevention among community-dwelling older adults
Acronym
The impact of social capital and meaningful work on caregiver prevention
Scientific Title
The impact of health-related social capital and meaningful work on health-related quality of life and care prevention among community-dwelling older adults
Scientific Title:Acronym
The impact of social capital and meaningful work on caregiver prevention
Region
| Japan |
Condition
Condition
Approximately 1,600 community-dwelling elderly persons aged 65 or older who do not have access to long-term care insurance will be included in the study.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.The purpose of this study is to clarify the relationship between social participation and health-related quality of life, social capital, and meaningful work among the elderly living in the community.
2.The purpose of this study is to clarify the relationship between social participation and health-related quality of life (QOL), social capital, and meaningful work among community-dwelling elderly people, and to clarify the relationship between support for social participation and the outcomes sought by the government, such as lower rates of certification for support and nursing care and lower nursing care benefit costs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related quality of life (EQ-5D-5L), long-term care certification rate and long-term care benefit costs
Key secondary outcomes
Frailty Determination by Basic Checklist
Health-related social capital indicators at the regional level
Performances, satisfaction, and frequency of meaningful tasks
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 94 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study will target approximately 1600 of the elderly residents of Obuse-cho, Nagano Prefecture who are 65 years of age or older, and who do not use long-term care insurance, and who fall into each of the following categories.
Key exclusion criteria
people who use long-term care insurance (e.g., those who have died, moved, hospitalized, etc.)
Death,relocation,hospitalization,etc. difficult to trace
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Obuchi |
| Middle name | |
| Last name | Kohei |
Organization
Nagano Matsudai General Hospital
Division name
Rehabilitation Department
Zip code
3811231
Address
183 Matsushiro, Matsushiro-cho, Nagano City, Nagano Prefecture
TEL
0262782031
kindai0707@gmail.com
Public contact
Name of contact person
| 1st name | Obuchi |
| Middle name | |
| Last name | Kohei |
Organization
Nagano Matsudai General Hospital
Division name
Rehabilitation Department
Zip code
3811231
Address
183 Matsushiro, Matsushiro-cho, Nagano City, Nagano Prefecture
TEL
0262782031
Homepage URL
kindai0707@gmail.com
Sponsor or person
Institute
Nagano Matsudai General Hospital
Institute
Department
Personal name
Funding Source
Organization
without
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagano Matsudai General Hospital
Address
183 Matsushiro, Matsushiro-cho, Nagano City, Nagano Prefecture
Tel
0262782031
kindai0707@gmail.com
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
長野松代総合病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 10 | 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
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2033 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 18 | 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
In this study, we will clarify the effects of environmental support, such as the creation of social capital and the continuation of meaningful tasks, activities, and daily living for people living in the community, on psycho-psychological and social frailty in the elderly, where physical frailty has been the main focus of improvement. The study will also clarify the cost-effectiveness of the environmental support. If the cost-effectiveness of the system can be clarified, it will be possible to develop the system as a long-term care prevention program and policy that can contribute to reducing the cost of long-term care.
Management information
Registered date
| 2023 | Year | 04 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057852
