UMIN-CTR Clinical Trial

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
Email	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
Email	aiko@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053318