UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046732 |
|---|---|
| Receipt number | R000053318 |
| Scientific Title | Development of a tool for assessing the working ability in persons with mild cognitive impairment and dementia |
| Date of disclosure of the study information | 2022/01/26 |
| Last modified on | 2022/01/26 10:33:54 |
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Basic information
Public title
Development of a tool for assessing the working ability in persons with mild cognitive impairment and dementia
Acronym
Assessment of working ability for cognitive impairment
Scientific Title
Development of a tool for assessing the working ability in persons with mild cognitive impairment and dementia
Scientific Title:Acronym
Assessment of working ability for cognitive impairment
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment and Dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a simple assessment of the working ability with medical reliability and validity for persons with mild cognitive impairment and dementia
Basic objectives2
Others
Basic objectives -Others
Cross-sectional study on working ability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Working ability; working time, number of errors, type of the errors, amount of assistance
Key secondary outcomes
Visual analog scale(VAS)
The Clinical Dementia Rating (CDR)
Handgrip strength
Simple Test for Evaluating hand function (STEF)
Mini-mental State Examination (MMSE)
Montreal Cognitive Assessment (MoCA-J)
Memory span(forwards)
Trail Making Test (TMT)
Communication Activity of Daily Living Test (CADL)
Auditory Verbal Learning Test (AVLT)
Behavioral Assessment of the Dysexecutive Syndrome (BADS)
Raven's Colored Progressive Matrices (RCPM)
The Rivermead Behavioral Memory Test (RBMT)
Self-rating Depression Scale(SDS)
Neuropsychiatric Inventory (NPI)
Barthel Index (BI)
MRI(VSRAD)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with mild cognitive impairment and dementia in our Rehabilitation Center
Patients with MMSE score >=15
Family
Key exclusion criteria
Those who are difficult to hold a sitting position for more than 60 minutes
Those who are difficult to understand the meaning of research, contents of the questionnaire, or how to work due to aphasia etc.
Those who are difficult to participate in the working task due to visual impairment
Those who are difficult to participate in the working task due to severe psychiatric symptoms of dementia
Those who are not permitted to hold a sitting position and working for more than 60 minutes due to other diseases
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Arai |
Organization
National Center for Geriatrics and Gerontology
Division name
President
Zip code
474-8511
Address
7-430, Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562462311
harai@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Osawa |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu, Aichi, 474-8511, Japan
TEL
0562462311
Homepage URL
aiko@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Uemura Co., LTD
Organization
Division
Category of Funding Organization
Profit organization
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
Address
7-430, Morioka-cho, Obu, Aichi, 474-8511, Japan
Tel
0562462311
cgss-frailty@ncgg.go.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
| 2022 | Year | 01 | Month | 26 | 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
90
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the relationship between patients attributes dementia severity, cognitive function, behavior or psychological symptoms of dementia, upper limb function, ability of activity of daily living, neuroimaging findings and working ability, we will calculate Spearman's rank correlation coefficient.
Management information
Registered date
| 2022 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053318
