UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024098 |
|---|---|
| Receipt number | R000027741 |
| Scientific Title | The relationship between the abilities of language, memory, discourse and communication in the demented elderly -the analisis from the view point of familiy- |
| Date of disclosure of the study information | 2016/09/18 |
| Last modified on | 2017/10/02 17:02:54 |
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Basic information
Public title
The relationship between the abilities of language, memory, discourse and communication in the demented elderly -the analisis from the view point of familiy-
Acronym
The communication between demented elderly and their families
Scientific Title
The relationship between the abilities of language, memory, discourse and communication in the demented elderly -the analisis from the view point of familiy-
Scientific Title:Acronym
The communication between demented elderly and their families
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
systematise the augmentative and alternative communication based on the cognitve neuropsychological findings of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluate the efficacy of designed AAC in about three months during which the subjects are traind to use the AAC
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
design and train the AAC suitabe for the cognitive neurospychological status of the subject
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with dementia
Key exclusion criteria
physicallly unstable, difficult to understand the instructions, difficult to respond
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takako Yoshimura |
Organization
Kyoto Gakuen University
Division name
Department of health and medical sciences
Zip code
Address
18, Gotanda-cho, Yamanouchi, Ukyo-ku, Kyoto
TEL
075-406-9159
takakoy@kyotogakuen.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Narisuke Nonami |
Organization
Kyoto Gakuen University
Division name
center for study and community
Zip code
Address
18, Gotanda-cho, Yamanouchi, Ukyo-ku, Kyoto
TEL
075-406-9111
Homepage URL
nonami@kyotogakuen.ac.jp
Sponsor or person
Institute
Kyoto Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
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
| 2016 | Year | 09 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 18 | Day |
Last modified on
| 2017 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027741
