UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057893 |
|---|---|
| Receipt number | R000066170 |
| Scientific Title | A pilot study on the effects of welfare-based employment for older adults with cognitive decline |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/07/30 14:26:29 |
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Basic information
Public title
A study to support continued employment for individuals experiencing work difficulties due to memory loss and related cognitive challenges
Acronym
A study on continued employment for individuals with memory impairment
Scientific Title
A pilot study on the effects of welfare-based employment for older adults with cognitive decline
Scientific Title:Acronym
Pilot program of welfare-based employment for individuals with MCI
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, from the perspective of extending healthy life expectancy, there has been a demand for the elderly to continue working, such as by extending retirement age.In Japan, there is a welfare-based employment system called "Type B Support for Continuous Employment," which enables elderly people with cognitive decline to continue working while receiving support.It is expected that the "rewarding" activity of continued employment will suppress the decline in cognitive function and life function, but such an effect has not been demonstrated in practice.One possible way to demonstrate this is to verify whether the progression of decline in cognitive and life functions is suppressed when elderly people with mild cognitive impairment (MCI) use Type B Continuous Employment Support as welfare-type employment.In this study, we will conduct a pilot study to investigate 1) whether there is a need for elderly people with mild cognitive impairment (MCI) to use Type B continuous employment support as welfare employment, and 2) whether it is feasible to conduct research on whether elderly people with mild cognitive impairment (MCI) can suppress the progression of decline in cognitive function and daily life function by using Type B continuous employment support as welfare-based employment.This is a pilot study to explore the feasibility of conducting a study to determine whether the progression of cognitive and lifestyle function decline can be reduced when elderly people with cognitive impairment (MCI) use support for continuous employment as welfare-based employment.If needs and feasibility are identified in this study, it can be developed into a larger, more detailed study of welfare-based employment for MCI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Ability to Perform Activities of Daily Living Six Months After Beginning Welfare-Based Employment
Key secondary outcomes
Changes in Cognitive Function Six Months After Beginning Welfare-Based Employment
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who meet the criteria for MCI (MoCa-J score of 25 or less and MMSE-J score of 24 or more)
Individuals aged 60 years or older and under 85 years old.
The "work group": Individuals who wish to work at Type B continuous employment support and agree to participate in the study
Control group: Individuals who do not wish to work at Type B continuous employment support, but agree to participate in the study as a control group
Key exclusion criteria
Individuals who continue to work in general employment or through organizations such as the Silver Human Resources Center (self-employment or unpaid labor is not considered employment)
Individuals for whom participation in Type B continuous employment support is difficult due to physical limitations
Others deemed unsuitable for participation by the researcher, such as those with emotional instability
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ide |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
029-888-4000
ide.masayuki.ga@alumni.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ide |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
029-888-4000
Homepage URL
ide.masayuki.ga@alumni.tsukuba.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
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
Research Ethics Comittee, Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-mach, Inashiki-gun, Ibaraki, Japan
Tel
029-888-4000
kyoumu@ipu.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
茨城県
Institutions
Institutions
茨城県立医療大学（茨城）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 30 | 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 | 05 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-randomized parallel-group comparative study
Management information
Registered date
| 2025 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066170
