UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033967 |
|---|---|
| Receipt number | R000038743 |
| Scientific Title | Verification of effectiveness of conversational assessment of cognitive function |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2018/08/31 11:55:52 |
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Basic information
Public title
Verification of effectiveness of conversational assessment of cognitive function
Acronym
The effectiveness of conversational assessment of cognitive function
Scientific Title
Verification of effectiveness of conversational assessment of cognitive function
Scientific Title:Acronym
The effectiveness of conversational assessment of cognitive function
Region
| Japan |
Condition
Condition
Dementia, Mild Cognitive Impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the verify the effectiveness of conversational assessment of cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conversational Assessment of Neurocognitive Dysfunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A clinical psychologist performs a cognitive test, and then another staff member communicate with the elderly person and evaluates the conversational assessment of neurocognitive dysfunction (CANDy). Caregivers were also asked to evaluate the CANDy.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years and caregivers who attend the department of psychiatry, University Hospital, Kyoto Prefectural University of Medicine.
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hikaru Oba |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of psychiatry, graduate school of medical science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5612
hkroba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hikaru Oba |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of psychiatry, graduate school of medical science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5612
Homepage URL
hkroba@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 04 | 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
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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038743
