UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050225 |
|---|---|
| Receipt number | R000056864 |
| Scientific Title | Investigation of the effectiveness of reducing the burden of stress and improving work efficiency by using Cog-Map |
| Date of disclosure of the study information | 2023/02/03 |
| Last modified on | 2025/03/18 09:03:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the effectiveness of reducing the burden of stress and improving work efficiency by using Cog-Map
Acronym
Investigation of the effectiveness of reducing the burden of stress by using Cog-Map
Scientific Title
Investigation of the effectiveness of reducing the burden of stress and improving work efficiency by using Cog-Map
Scientific Title:Acronym
Investigation of the effectiveness of reducing the burden of stress by using Cog-Map
Region
| Japan |
Condition
Condition
None.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efforts to reduce the stress of families caring for dementia patients are an essential issue. We will verify the reduction of stress using our proprietary "Cog-Map." For dementia patients and families caring for the elderly, Cog-Map may reduce stress and the burden of caregiving. Before verifying the reduction of the burden on caregivers of dementia patients, we will first conduct research targeting general working adults. A pilot randomized controlled trial will be conducted to verify the reduction of stress burdens in the workplace and the improvement of work efficiency before and after implementation of the Cog-Map, comparing the conventional checklist method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coping Inventory for Stressful Situations (CISS)
Key secondary outcomes
1. Psychological Well-Being Scale
2. Persistence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cog-Map
Interventions/Control_2
Checklist
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
General working adults in local governments or companies. Any gender, age, and healthy state.
Key exclusion criteria
None.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Sato |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Aging Neurobiology
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
(0562)46-2311
nsato@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Sato |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Aging Neurobiology
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
(0562)46-2311
Homepage URL
nsato@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology Ethics Committee
Address
7-430, Morioka, Obu, Aichi
Tel
(0562)46-2311
yaday@ncgg.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1571
Org. issuing International ID_1
National Center for Geriatrics and Gerontology
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 03 | 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
| 2022 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
10 people participated in this study.
Management information
Registered date
| 2023 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056864
