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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024098
Receipt No. 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

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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
Email 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
Email nonami@kyotogakuen.ac.jp

Sponsor
Institute Kyoto Gakuen University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027741

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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