UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058022 |
|---|---|
| Receipt number | R000066314 |
| Scientific Title | Study of developing dementia-friendly society through inclusive workplace: A pilot study |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/30 11:20:50 |
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Basic information
Public title
Study of developing dementia-friendly society through inclusive workplace: A pilot study
Acronym
Dementia-friendly workplace
Scientific Title
Study of developing dementia-friendly society through inclusive workplace: A pilot study
Scientific Title:Acronym
Dementia-friendly workplace
Region
| Japan |
Condition
Condition
Dementia and cognitive impairment
Classification by specialty
| Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previous in-depth interviews with individuals who had been diagnosed with dementia and were engaged in inclusive work environments revealed that such engagement enhanced their self-esteem and promoted their mental well-being.
The present study aimed to explore the potential effects of inclusive work participation on the cognitive function, mental health, and social participation of individuals with cognitive decline, as well as on the mental health of their family members.
This study is positioned as a pilot study intended to inform the design of a future randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The Japanese version of the World Health Organization-Five Well-Being Index
Key secondary outcomes
[People with dementia/cognitive impairment].
1. Changes in mental health (UCLA Loneliness Scale, Rosenberg's Self-Esteem Scale, EQ-5D-5L, General Self-Efficacy Scale, Old Age Depression Rating Scale)
2. Changes in social indicators (frequency of interpersonal interactions, frequency of outings, LSNS-6, social support)
3) changes in cognitive functioning as measured by cognitive tests (MMSE-J, MoCA-J, TMT-A,B, word recall task); 4) changes in physical functioning tests (hand, finger and handwritten instruments); 5) changes in physical functioning tests (hand, finger and handwritten instruments).
4. Changes in physical function tests (hand dexterity (Pardue peg board test), grip strength, pinch strength)
5. Changes in oral function (OF-5)
6. thoughts about working, thoughts about the future, thoughts about dementia, willingness to continue working, etc. as assessed in narrative interviews
7. Changes in the work performance ability
[Family]
1. Changes in mental health (WHO-5-J, UCLA Loneliness Scale, CES-D)
2. Changes in sense of care burden (J-ZBI_8)
3. Changes in the Dementia Friendly Scale
4. the person's living situation, thoughts about the person, concerns about care and living, etc. as assessed in the narrative interview
[Workplace staff]
1. The state of the subject's working life, etc. as assessed by narrative interviews
2. Consideration of feasibility (narratives) after completion of the project
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
To work at one company two days a week for at least two hours each time, for a period of three months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. has a DSM5 diagnosis of Major/Mild Neurocognitive Disorder and an MMSE score between 16 and 30
2. willing to work twice a week at X Ltd.
3. not working in any other job
4. have written consent from the individual to participate in the study
5. has a family member, if any, who also agrees to participate
6. can read, write and speak Japanese well enough
7. able to go to the study site on their own
Key exclusion criteria
1. is in acute treatment for mental or physical illness
2. has a family member who does not agree to participate
3. has a guardian, assistant or assistant under the Adult Guardianship Act
4. clearly functionally incapable of doing the work
5. otherwise judged by the researcher to be unsuitable for this study
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okamura |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi, Tokyo, JAPAN
TEL
0339643241
t.okamura.jp@gmail.com
Public contact
Name of contact person
| 1st name | Hana |
| Middle name | |
| Last name | Sakurai |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi, Tokyo, JAPAN
TEL
0339643241
Homepage URL
hsakurai@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Tsuyoshi Okamura
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2, Sakae-cho, Itabashi, Tokyo, JAPAN
Tel
0339643241
hsakurai@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
| 2025 | 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
3
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066314
